Minutes For 260 Meeting Registration Board Held On 28-29 June, 2016

Minutes for 260th Meeting Registration Board held on 28-29th June, 2016.
Item No. Detail of Item Page No(s)
Item No.I Confirmation for minutes of 259th Registration Board meeting 04
Item No.II Pharmaceutical Evaluation & Registration Division 05 - 375
Item No.III Biological Drugs Division 376 - 483
Item No.IV Quality Assurance & Laboratory Testing Division 484 – 490
Item No.V Additional cases 491 - 493
Minutes for 260th Meeting Registration Board 1

260th meeting of Registration Board was held on 28-29th June, 2016 in the Committee
Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by
Mr. Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division,
DRAP. The meeting started with recitation of the Holy Verses. The meeting was attended by the
following:-
1. Lt General (R) Karamat Ahmed Karamat. Member
2. Brig (R). Dr. Muzammil Hasan Najmi, Member

Associate Dean, Basic Sciences Division,
Foundation University Medical College, Rawalpindi
3. Mr.A.Q.Javed Iqbal Member
4. Sheikh Sarfraz Ahmad Member

Additional Draftsman, M/o Law and Justice
5. Mr.Ghulam Mujtaba, Assistant Director Member
Representative of IPO
6. Dr.Muhammad Arshad Member
President, Pakistan Veterinary Medical Council
7. Dr.Amanullah Khan Member
Director Drugs Testing Laboratory
Government of Baluchistan, Quetta
8. Dr.Muhammad Khalid Khan Member
Government of Khyber Pakhtunkhwa, Peshawar
9. Mr.Abdus Salam Shah Member
Government of Sindh, Karachi
10. Mr.Saleem Butt Member
Government of Punjab, Rawalpindi
11. Shaikh Ansar Ahmad, Member
Director Biological Drugs Division, DRAP
12. Dr.Noor Muhammad Shah Member
Director Medical Device Division, DRAP
13. Dr.Abdur Rasheed Member
Chairman, Quality Control
QA&LT Division, DRAP

14. Dr. Obaidullah, Deputy Director General (Reg.I) Secretary
Dr.Muhammad Khalid Khan attended the meeting on 28.06.2016 while Dr.Muhammad

Arshad and Mr.Abdus Salam Shah participated on 29.06.2016 only.
Dr.Masud-ur-Rehman (DDG Biological), Zaheer-ud-Din M Babar (DDC R.I/R IV),

Muhammad Akhter Abbas (DDC/Incharge, PEC), Dr.Hafsa Karam Elahi (DDC,PEC),
Muhammad Amin (DDC R.V / DDC,PEC), Tehreem Sara (DDC RRR), Adnan Faisal Saim
(DDC,QC), Babar Khan (ADC R.II/RIII), Dr.Ghazanfar Ali Khan (ADC RRR), Salateen
Waseem Phillips (ADC,PEC), Muhammad Ansar (ADC,PEC) and Muneeb Cheema
(ADC,Biological) assisted relevant Directors and Secretary of the Board with agenda.
Shafiq Ahmad Abbasi, Ayub Siddique, Nadeem Alamgeer and Abuzar Faizi Rattu
attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively.
In addition to routine agenda, following was also discussed and decided:
 Registration Board deliberated that only those drugs will be registered for import from
India, which are as allowed / permissible as per Import Policy Order, 2016 (Ministry of
Commerce).

Item No. I: Confirmation of minutes of 259th meeting Registration Board.
259th meeting of Registration Board was held on 30-31st May, 2016. Draft minutes were
circulated to all members (who attended the meeting) on 15.06.2016 through e-mail with the
request to forward their comments (if any) within 05 days. 02 members forwarded their
comments / observations, as follows:
 Dr.Amanullah Khan, Director DTL, Quetta:

Item No.III, Case No.01:
It may be decided as per decision of Registration Board.
 Dr.Noor Muhammad Shah, Director Medical Device, DRAP:

While discussing observation of Dr.Amanullah regarding registration of Injection Ropegra, the
members were informed that the Board endorsed the statement of registration of the product in
parawise comments submitted before the court and change in source was accordingly approved.
Member including the undersigned stated that Board has its own wisdom and procedure for
registration of drugs instead of endorsing of parawise comments. It was also submitted that as
necessary requirements were fulfilled, registration should have been granted for the new source
instead of change of source.
Keeping in view comments of Dr.Amanullah Khan, Director DTL, Quetta, respective
case is again placed as agenda item (Item No.II, Case No.01).
Decision: Registration Board deliberated that points observed by Director Medical

Device, DRAP has already been discussed in previous meetings. Hence
Registration Board confirmed minutes of 259th meeting Registration Board.

Item No. II: Pharmaceutical Evaluation & Registration Division.
Case No.01: New committee(s) for on-site inspection of stability data or any other
assignments.
Registration Board in 258th meeting considered following proposal of Dr.Muhammad

Khalid Khan, Director DTL, Peshawar forwarded in response to draft minutes of 257th
Registration Board meeting. Dr.Amanullah Khan, Director DTL, Quetta has also endorsed these
observations.
As per decision of the Registration Board to verify stability data as per site and in this
connection already one committee was constituted which is working. However as a member
of Registration Board I do feel that only one committee is not sufficient to look after the
entire Pharma of the country therefore to avoid unnecessary delay for onsite verification of the
data the board may constitute new committee(s) in the public interest compromising of members
of the Registration Board only. Registration Board may also develop rationalized check list for
onsite verification of the data with clear, time Bound Terms of Reference.
Registration Board after deliberation deferred the case and advised Pharmaceutical
Evaluation Cell to bring complete details / data of stability datas submitted by the manufacturers
in forthcoming meeting. Accordingly, following data is submitted for consideration of
Registration Board.
S.No Name of Drug & Composition No of applicants / manufacturers

1. Capsule Dex-Lansoprazole 30mg, 60mg 02
2. Tablet Sofosbuvir 400mg 03
3. Tablets Cinacalcet 30 mg, 60 mg 01
4. Tablet Mirabegron 25mg, 50mg 01
5. Tablet Sitagliptin+Metformin XR 50/500, 01
50/1000, 100/1000
In 259th meeting, Registration Board decided as follows:
Registration Board deliberated the matter in detail and decided that already constituted panel
(Brig (R) Muazmmil Najmi, Dr.Obaidullah and Dr.Saif-ur-Rehman Khattak) will continue to
inspect pharmaceutical units for onsite investigation to confirm genuineness/ authenticity of
stability data and associated documents, import of API, quality, specification, test analysis,

facilities for Anti-retroviral drugs. For rest of formulations, following panels are constituted for
aforementioned purposes.
 Sind and Balochistan: Director DTL Karachi; Director DTL Quetta and area
FID, DRAP.
 Punjab: Director DTL Lahore; Director DTL Peshawar and

area FID, DRAP.
 Islamabad, AJK and KPK: Director DTL Rawalpindi; Director DTL Peshawar and
area FID, DRAP.
Registration Board also approved above panels for confirmation genuineness/

authenticity of stability data and associated documents, import of API, quality, specification, test
analysis, facilities for various applications.
Decision: Registration Board deliberated the matter and decided that already
constituted panel (Brig (R) Muazmmil Najmi, Dr.Obaidullah and Dr.Saif-ur-Rehman
Khattak) will continue to inspect pharmaceutical units for onsite investigation to confirm
genuineness/ authenticity of stability data and associated documents, import of API,
quality, specification, test analysis, facilities for Anti-retroviral drugs. For rest of
formulations, following panels are constituted for aforementioned purposes.
 Sind and Balochistan: Director DTL Quetta (Chairman), Director DTL

Karachi (Member); and area FID, DRAP
(Member / Convener).
 Punjab: Director DTL Peshawar (Chairman), Director DTL
Lahore; and area FID, DRAP (Member/Convener).
 Islamabad, AJK and KPK: Director DTL Peshawar (Chairman), Director DTL
Rawalpindi and area FID, DRAP (Member/Convener).
Case No.02: Price fixation under the Drug Pricing Policy-2015.
Drug Pricing Committee referred the under mentioned five cases of price fixation for
policy guidelines from the Policy Board of the Authority for price fixation of drugs whose plain
formulations or injections in vials/ampoules are available in the market at much lower prices and
the companies have applied for price fixation of sustained release formulations or injections in
prefilled syrings or modification in dosage administration / drug delivery device respectively.
These formulations are not new chemical entities and DPC could not find any guideline in the
Drug Pricing Policy -2015 to fix prices of these formulations at much higher prices. Therefore,

DPC decided to refer the following cases of price fixation to the Policy Board of the Authority
for policy guideline whose prcice fixation is not covered under the Drug Pricing Policy –2015.
S. Drugs / Composition Reasons for referring to the Policy Board for policy guideline
No.
1. Panadol Joint Tablets Plain tablets of Panadol 500mg of the same company are available
Each modified release tablet @ Rs.180.00/200’s (Rs.0.90/- per tablet) and the company is
contains:- demading Rs.200.00/20’s (Rs.10.00/- per tablet) for modified
Paracetamol Ph release of 665mg tablets.
Eur….665mg
Demanded price of 665mg modified release tablets @ Rs.10/- per
M/s GSK, Karachi tablet is much high in comparison to price of 500mg plain tablet of
(M-243) the same company available @ Rs.0.90/- per tablet.
It is not a new chemical entity. Reference price is neither available

nor applicable. DPC decided to refer the matter to Policy Boar for
policy guideline.
2. Sayana Press Injection PFS The company is already marketing injection of
104mg/0.65ml Medroxyprogesterone acetate 150mg per 1ml in vial dosage form @
(Medroxyprogesterone Rs.153.16/1ml x 1’s under the brand name “Depo-Provera”.
acetate)
Pre-filled injection system Now the company has applied for price fixation of same drug
contains Depo- (Medroxyprogesterone acetate) for 104mg per 0.65ml under the
medroxyprogesterone acetate brand name “Sayana Press Injection PFS” and demaned maximum
(DMPA) 104mg/0.65ml retail price of Rs.1078/- per injection in Pre-filled syringe.
 Imported by Pfizer Demanded price of Sayana Press Injection @ Rs.1078/- per

Pakistan Limited, injection is much higher in comparison to already available brand
Karachi “Depo-Provera” of the same company @ Rs.153.16 per injection
 Imported from (vial).
Manufacturer: Pfizer
Manufacturing It is not a new chemical entity. Reference price is neither available
Belgium NV, nor applicable. DPC decided to refer the matter to Policy Boar for
Rijksweg 12, 2870 policy guideline.
Puurs, Belgium.
Main indications:
Contraceptive, depot
effective for at least 13
weeks.

No.
3. Ritalin LA Capsules 20mg The company is already marketing Methyphenidate hydrochloride
Each capsule contains:- 10mg Tablets in plain tablet dosage form @ Rs.140.00 per pack of
Methyphenidate 10 tablets under the same brand name “Ritalin Tablets”.
hydrochloride…..20mg
(M-245) Now the company has applied for price fixation of same drug
 Imported by M/s. (Methyphenidate hydrochloride) for 20mg per capsule under the
Novartis Pharma brand name “Ritalin LA Capsules 20mg ” and demaned maximum
(Pakistan) Ltd. retail price of Rs.2400.00/- for a pack of 30 capsules (Rs.80/- per
Karachi/ capsule).
 Imported from M/s.
Elan Holdings Inc, Demanded price of Ritalin LA Capsules 20mg @ Rs.2400.00/- for
Georgiam, USA. a pack of 30 capsules (Rs.80/- per capsule) is much higher in
comparison to already available brand “Ritalin Tablets 10mg” of
the same company @ Rs.140.00 per pack of 10 tablets (plain)
(Rs.14/- per tablet).

policy guideline.
hydrochloride….320mg
(Pakistan) Ltd. retail price of Rs.3200.00/- for a pack of 30 capsules (Rs.106.67/-
Karachi/ per capsule).
Georgiam, USA. a pack of 30 capsules (Rs.106.67/- per capsule) is much higher in

policy guideline.

No.
hydrochloride…..40mg
(Pakistan) Ltd. retail price of Rs.3900.00/- for a pack of 30 capsules (Rs.130/- per
Karachi/ capsule).
Georgiam, USA. a pack of 30 capsules (Rs.130/- per capsule) is much high in

policy guideline.
Policy Board of the Authority in its 14th meeting held on 10th & 11th September, 2015 had
referred the matter to the Drug Registration Board to decide a specialized dosage form whether it
is a new drug or not and its price is to be granted. Accordingly as a new product or a same
product but different strength / different pack size as both are separately mentioned in the Drug
Pricing Policy-2015.
Decision: Mr.Abdul Ghaffar, DDC (Pricing) apprised Registration Board about the
case. The Board deferred the case for decision of DRAP’s Policy Board in
instant case for further deliberation.

RRR Division
Case No.03: Renewal of registered drug and Post-registration variation approval.
In 243rd Meeting of the Registration Board a following decision was made post-
registration variation was made and the extract is as under:
“Registration Board deliberated that transfer from one importer to another (with no change in
manufacturing site), change of brand name and change of name of manufacturer will be
considered as post-registration variation. Moreover, this approval will not be considered as
renewal of the product and firm will apply for renewal of product as per procedure and will be
processed as per import policy for finished drugs.”
Although decision was made as above but notification to this effect for not considering
post-registration variations towards renewal products was not issued and the firms are still
considering/applying renewal of registration from their date of post-registration variations.
Case was deliberated in 259th Registration Board meeting and decided to bring the issue
as agenda in the forthcoming meeting for discussion.
Decision: Registration Board deliberated on the matter at length and decided post-
registration variations shall not be considered towards renewal of products
w.e.f 01-10-2016. However, it was observed that renewal applications already
submitted or to be submitted till 30.09.2016 shall be considered from post
registration varioation, if appled by the firm.
Case No.04: Renewal of Registered drugs.
Number of applications submitted for renewal of drugs which are incomplete or have
shortcoming especially with reference to the submitted prescribed renewal fees. The following
applications for renewal of drugs are submitted on Form 5-B after the expiry of validity of the
certificate of registration but within sixty days after validity of certificate of registration. The
applications for renewal are incomplete with reference to renewal application fee or having some other
deficiency.
Rule 27 Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of certificate of
registration). A certificate of registration under this chapter, [shall unless earlier suspended or
cancelled, be in force for a period of five years from the date of [Registration of the drug] and may
thereafter be renewed for period not exceeding five years and a certificate to this effect shall be
issued within one month] at a time.

Provided that an application for the renewal of registration shall not be entertained unless it has
been made within sixty days after the expiry of the registration and when an application has been
made aforesaid the registration shall subject to the orders passed on the application for the renewal
continue in force for the next period of five years and a certificate to this effect shall be issued within
one month].
Provided further that in case of an imported drug, the renewal may be granted and a renewal
certificate shall be issued, if in the opinion of the Registration Board it is necessary to do so in the
public interest.
Following cases are placed below for the consideration of Registration Board.
a. M/s Prix Pharma Lahore.
S. Reg/No Products/Name Initial Date of Application receiving

No Registration date
and fee submitted date/
and due date
1 014568 Farbenda Oral Suspension 22-2-1994 Due date (21-2-2014)
Each ml contains 17-3-2014
Albendazole…. 100 mg Fee of Rs. 40,000/-
deposited on 17-03-2014
Decision: Firm submitted renewal application within 60 days of expiry period of

registration time i.e; 17-03-2014 with fee of Rs. 40000/-, therefore
Registration Board decided to grant renewal of above product till 21-02-2019
subject to adherence to the Import Policy for Finished Drugs.
b. M/s Navegal Laboratories Rawalpinid.
S. Reg/No Products/Name Date of Application receiving date

No transfer of and fee submitted date/
Reg. and due date
1 015732 Naveten 1 mg tablet 21-1-2008 Due date (20-1-2013)
Each tablet contains 19-2-2013
Ketotifen Fumerate.. 1 mg Fee of Rs. 60,000/-
deposited on 19-02-2013
2 015731 Piram 20 mg capsule do
Each capsule contains do
Piroxicam…..20 mg
3 018979 Zantidon 150 mg tablets do
Each tablet contains do
Ranitidine HCl… 150 mg

registration time i.e. 19-02-2013 with full fee, therefore Registration Board
decided to grant renewal of above products at serial No. 1 to 3 till 20-01-2018.
c. M/s Nabiqasim Industries (Pvt) Ltd Karachi.
S. Reg/No Products/Name Initial Date Application receiving date

No of and fee submitted date/ and
Registratio due date
n
1 053139 Deplat-AP Tablet 1-12-2008 Due date (30-11-2013)
Clopidogrel Fee of Rs. 20,000/- deposited
(as bisulphate)…. 75 mg on 10-12-2013
Aspirin BP….. 75 mg
(Manufacturer’s Specification)
2 053135 Lungair 4 mg tablet do
Each chewable tablet contains do
Montelukast Acid (as
sodium)………. 4 mg
3 053142 Valset 250 mg tablet do do
Each tablet contains
Valproic Acid (as
4 053133 Ordiab 5/500 tablet do do
Glipizide……. 5.00 mg
Metformin Hydrochloride…
500 mg
5 053138 Clarithro 125mg/5ml Oral do do
Drops
Each 5ml contains
Clarithromycin …….. 125 mg
6 053140 Lumether tablet do do
Artemether ……… 20.00 mg
Lumefantrine…… 120.00 mg
7 053136 Lungair 4 mg Sachet do do
Each chewable tablet contains
Montelukast Acid (as
registration time i.e; 10-12-2013 with full fee, therefore Registration Board
decided to grant renewal of above products at serial No. 1 to 7 till 30-11-2018.
d. M/s Mediate Pharmaceuticals (Pvt) Ltd Karachi.
S. Reg/No Products/Name Initial Date Application receiving

No of Reg. date
and fee submitted
date/ and due date
1 006919 Mefenemic tablet 9-3-2004 Due date (8-3-2014)
Mefenamic Acid……. 250 mg Fee of Rs. 10,000/-
deposited on 11-3-
2014. Remaining fee of
Rs/ 10,000 deposited
on 18-5-2016
2 012123 Tr.Iodine Solution do do
Each contains
Iodine……… 5 gm
Potaqssium Iodide……. 10 gm
3 012449 Benephal Capsule do do
Each Capsule contains
Cephalexin……….. 250 mg
4 012451 Lakenine Capsule do Do
Each capsule contains
Ampicillin Trihydrate eq.to
Ampicillin Base…..250 mg
5 006920 Seladrine tablet do Do
Chloroquine Phosphate eq.to
Chloroquine base……. 80 mg
6 004327 Seladrine tablet do Do
Chloroquine Phosphate250 mg
7 011342 Frusemide tablet do Do
Frusemide……….. 40 mg
8 010526 Trupentine Liniment do Do
Contains
Soft Soap……….. 75 gm
Turpentine Oil…… 650 ml
Purified water…….. 225 ml
(Fresh boiled& cooled
Camphor……….. 50 gm

9 010287 Polter past Ointment do Do
Each 400 gm contains
Heavy Kaolin……..52.7 gm
Boric Acid………….04.5 gm
Methylsalicylate…….. 00. 2ml
Thymol…………….. 50.0 mg
Pepermint Oil…… 0.05 ml
Glycerol………….. 42.5 gm
10 004488 Aspera-Co tablet do Do
Aspirin…………… 300 mg
Paracetamol……….. 200 mg
Caffeine…………. 30 mg
11 009043 Feverol Suspension do Do
Each 5ml contains
Paracetamol………… 120 mg
12 010289 Decmasil tablet do Do
Magnesium Trisilicate.. 500 mg
13 011180 Duocarte Solution do Do
Contains
Salicylic Acid…….. 16.7%
Lactic Acid………. 16.7%
14 012125 Decsazone tablet do Do
Dexamethasone……… 0.5 mg
15 012124 Aminophylline tablet do Do
Aminophylline………. 100 mg
16 006917 Dep-Roll tablet do Do
Aspirin…………. 300 mg
17 010286 Inchthazmol Glycerin do Do
Each contains
Inchthazmol Glycerin….10%/w/w
18 012448 Benaphal Capsule do Do
Cephalexin………… 500 mg
19 009352 Cetadrine tablet do Do
Ephedrine………….. 30 mg
20 009042 Anatrate Syrup do Do
Each 5ml contains
Sodium Citrate……. 37.625 Kgs
Citric Acid………. 14.200 Kgs

21 004489 Predamenium tablet 4 mg do Do
Chlorpheniramine Maleate…. 4mg
22 009044 Freshmasil Syrup do Do
Each 5ml contains
Ammonium Chloride….. 100 mg
Sodium Citrate…… 60 mg
Chlorpheniramine Maleate…… 2mg
Ephedrine HCL….. 7 mg
Menthol…………. 1 mg
23 010525 Mercurochrone Solution do Do
Contains
Mercurochrone Solution….1%/w/w
Clean Skin Lotion
Contains
Calamine………….. 15%
24 004601 Ascorbic Acid tablet do Do
Ascorbic Acid……… 50 mg
25 007032 Cake-Sea 500 tablet do Do
Ascorbic Acid……. 500 mg
26 006918 Paracetamol tablet do Do
Paracetamol ………. 500 mg
27 010524 Gentian Violate Paint do Do
Contains
Crystal Violet in water…. 0.5%/w/w
28 007033 Mad folic tablet do Do
Folic Acid………. 5 mg
29 009353 Kotria tablet do Do

Trimethoprim………. 80 mg
Sulphamethoxazole……. 400 mg
30 004328 Paracambind tablet do Do

Paracetmol ………..300 mg
Aspirin……….. 200 mg
31 010577 Clean Skin Solution do Do

Contains
Calamine………..15%

32 012450 Lakcine Capsule do Do
Ampicillin Thydrate eq.to
Ampicillin Base ……500 mg
33 006921 Sodamint tablet do Do
Sodium Bi Carbonate… 300 mg
34 004602 Kaleup tablet do Do
Calcium Lactate…… 300 mg
35 004603 Sulphadiazine tablet do do
Sulphadiazine……. 500 mg

registration time i.e; 11-03-2014 with full fee, therefore Registration Board
decided to grant renewal of above products at serial No. 1-35 till 08-03-2019.
e. M/s Shaheen Pharmaceuticals Swat.
S. Reg/No Products/Name Initial Date of Application receiving

No Registration date
and fee submitted date/
and due date
1 068418 Butone Elixir 2-12-2010 Due date (1-12-2015)
Each 5ml contains 3-12-2015 Fee of
Phenobarbitone…….20 mg Rs/10,000 deposited on
(shaheen Specification) 3-12-2015 remaining fee
of Rs 10,000/- deposited
on 15-2-2016

registration time i.e. 03-12-2015 with full fee, therefore Registration Board
decided to grant renewal of above product till 01-12-2020.

Registration-I
Case No.05: Request for change of manufacturer of Kefei ® Injection (Reg.No.059054) by

M/S. RG Pharmaceutical (Pvt.) Ltd, Karachi.
M/s. RG Pharmaceutical (Pvt) Ltd., Karachi had applied for change of

manufacturer/manufacturing site for their following already registered imported human product
from M/s. Guangzhou Lifetech Phrmaceutical Co. Ltd., China to M/s. Reyoung Pharmaceutical
Co., Ltd No. 06 Erlangshan Road, Yiyuan County, Shandong Province, P.R China:-
S. No. Reg. No. Name of Products.
1. 059054 KeFei ® Injection
Each vial contains:-
Levocarnitine for injection 1.0gm.
The firm have deposited required fee Rs.100,000/- and submitted following supporting
documents:-
i) Application on Form 5A.
ii) Copies of initial registration letters & renewal status.
iii) Original & legalized CoPP & GMP from China regarding new manufacturing facility.
iv) Site master plan of the manufacturer.
In 259th meeting The Registration Board observed that following points needs to be
clarified before taking decision:-
i. Brand name owner.
ii. Sole agency agreement from the new proposed manufacturer.
iii. NOC from previous manufacturer for the proposed change.
iv. Approval status by reference regulatory authorities.
The firm has submitted sole agency agreement from the new proposed manufacturer and
NOC from previous manufacturer mentioning that change of manufacturer of Kefei ® Injection
as requested above.
The availability of the drug as lypolized powder could not be confirmed in reference
countries like USA, EMA etc. Moreover, the Board observed that there is need to establish the
product license holder as in the CoPP given by the firm product license holder is mentioned for
generic name and brand name Kefei is not mentioned.
Decision: Registration Board advised to provide evidence of approval of the drug

(lyophilized form) by regulatory authorities of reference countries and also to

clarify the product license holder, who is authorized to make such request
alongwith supporting document.
Case No.06 Application for registration of drug of M/S. ICI, Karachi - remanded back
by Drug Appellate Board in its 144th Sitting.
The Appellate Board in its 144th sitting held on 22-12-2015 has, interalia, decided
to remand back the case filed by M/s. ICI, Karachi regarding rejection of transfer of registration
applications of following products:-
S. No. Reg. No. Brand Name

1 063792 Alba 10 Plus Suspension
2 075666 Alba 10 suspension
3 026563 Alba-25 suspension
4 063787 Albasan Plus 2.5 Suspension
5 069607 Alpro Suspension
6 059134 Bendol 2.5 Suspension
7 059153 Bendol 10 Suspension
8 059129 Clobendol 2.5 Suspension
9 063798 Cypercid Liquid
10 035082 Creezan suspension
11 059165 Cypermet Liquid
12 059161 Darsul Liquid
13 063559 Devotyl Liquid
14 063549 Enrolac 10 Liquid
15 075663 Enrocam Liquid
16 059113 Levanil Drench
17 075671 Motil Liquid
18 059144 Noworm Plus Suspension
19 059130 Oxanil Drench
20 063800 Oxfenox Plus Suspension
21 058800 Oxyfen S.C Drench
22 063790 Oxypro Drench
23 059124 Paranil Plus Suspension
24 059143 Paranil Gold Suspension
25 063556 Pulmopro Liquid
26 059109 Disulf Liquid
27 075656 Resporal Liquid
28 075667 Solvita-S Solution
29 002821-E Sist-Mix Drench
30 075665 Tryton suspension
31 075669 Tolzur Plus Liquid
32 075670 TY-Dox Plus Liquid
33 059107 Tenex Plus 8.75 Drench

34 057131 Toltrox Oral Solution
35 063791 Triclev 8.75 Drench
36 058780 Trisole S.C Drench
37 063563 Vorcid Suspension
38 059141 Wantox Drench
39 059110 Wantox Plus Drench
40 059103 Wantonil Plus Suspension
41 059155 Zurox Oral Solution
42 059150 Alincospectin Water Soluble Powder
43 075662 Almoxin-C Water Soluble Powder
44 075677 Avicox Water Soluble Powder
45 063555 Clarinal Powder
46 059154 Colicid Water Soluble Powder
47 063548 Colint Water Soluble Powder
48 059181 Comox Water Soluble Powder
49 059131 Cyclo-Mix 20 Premix
50 075668 Coxikil Water Soluble Powder
51 063796 Diurex Powder
52 059115 Doxityl WSP
53 059166 Doxi-Mix 50 Powder
54 063799 Etholon Powder
55 063788 Lincamox-S Water Soluble Powder
56 059159 Linco-Mix II Premix
57 075673 Macrodox Water Soluble Powder
58 059146 Neo-Stin Water Soluble Powder
59 075659 NCO-60 Water Soluble Powder
60 075660 Rapid-TD Water Soluble Powder
61 063797 Somcox Powder
62 057126 Sulfa-Vito Water Soluble Powder
63 057130 Sulzin Powder
64 075658 Super Leva Water Soluble Powder
65 075672 Super Flush Water Soluble Powder
66 059119 Trifon Powder
67 075657 Triclofon Powder
68 057129 Tydox Water Soluble Powder
69 059160 TY-Mix 10 Premix
70 049532 Ventilax Water Soluble Powder
71 059157 Vitavit-Adek Feed Premix
72 063553 Voladol Premix
73 059117 ZPS-100 Powder
74 052371 Almoxin 15% L.A Injection
75 063564 Amivit Injection
76 063551 Amcolox L.A Injection
77 059135 Amoxicure L.A Injection
78 063550 Amoxilist LA Injection

79 002820-E Bi-Sel E Injection
80 002819-E Bi-Strep Injection
81 057146 Biosign Injection
82 063552 Cal.D Lyte Injection
83 059175 Cefpro Injection
84 063557 Ceftron Injection
85 059174 Coligent Injection
86 071050 Control-CRD Injection
87 063786 Dayfos Injection
88 075654 Dimox Injection
89 059156 Diaminac Granules for Injection
90 059132 Diclonac Plus Inj.
91 059138 Dimenol Injection
92 063795 Dipyrene Plus Injection
93 059182 Dectron Injection
94 059147 Distilled Water for Injection
95 059106 Disulf Injection
96 057142 Dorvet Injection.
97 069606 Enrolac-10 Injection
98 059178 Enro-Pro10 Injection
99 059125 Flunix Injection.
100 059126 Fostel Injection
101 059136 Genton Injection 10%
102 075664 Genton 5% Injection
103 063558 Gentamix Injection
104 059151 Gencotyl Injection
105 059148 Gentrax Injection
106 059133 HIT-CRD Injection
107 059152 Ivoron Injection
108 059127 Ivoron Super Injection
109 063554 Melonac Injection
110 075652 Melonac Plus Injection
111 063794 Megaflux Injection.
112 059142 Mectin Plus Injection
113 057147 Metagen Injection
114 063547 Moxin Injection
115 059114 Onyx 50 Injection
116 075653 Oxytron LA Injection
117 059137 Onyx 100 Injection
118 059128 Onyx LA Injection
119 059149 Orasone Injection
120 075661 Oxytron 100 Injection
121 059145 OTC Forte LA Injection
122 057095 Pred Gold Injection
123 063561 Progent Injection

124 059162 Provet 40 Lac Dry Injection
125 075676 Pyraminol Injection
126 075674 Solodex Injection
127 075675 Supernova Infusion
128 059120 Spectral Injection
129 059158 Strepciben 5gm powder for Inj.
130 059176 Strepcin Injection
131 059180 Top-Vet Injection
132 059123 Triben Injection
133 057135 Triface Injection
134 057137 Tylo 2DHS Powder for Injection
135 002822-Ex Tri-Vit+ Injection
136 059108 Tylogent Injection
137 063789 Tylox-P Injection
138 059163 Tycolimet Injection
139 059173 Tylo-Pro 10 Injection
140 059177 Tylo-Pro 20 Injection
141 063793 Tryton Injection
142 075655 Tylox-20 Injection
143 059179 VAD3 Injection
144 059164 V-Sel Injection
145 057128 Variax Injection
146 063560 Vigorin Injection
147 044980 Albenda 250 Bolus
148 059104 Benvet Plus 250 Bolus
149 069605 Bendol 250 Bolus
150 059111 Bendol 500 Bolus
151 059139 Bengral Granules
152 059105 Benvet 600 Bolus
153 063562 Clovet Bolus
154 044978 Dart 350Bolus
155 059112 Deworm Bolus
156 059116 Fendamax Plus Bolus
157 059118 Nitron Bolus
178 002378-EX Oxyclozanide Super 750mg Bolus
159 059140 Paranil Bolus
160 044979 Zanisol Bolus
161 059122 Incramilk Granulated Powder
The Brief of the case presented in Registration Board meeting No. 245th held on 29-30th
September, 2014, is as under:-
M/s. ICI Pakistan Limited, Karachi had applied jointly with M/s. Breeze Pharma (Pvt)
Limited, Islamabad to the Central Licensing Board for acquisition of their license

premises situated at 125, 126, 127-A, Industrial Triangle, Kahuta Road, Islamabad, on
the basis of a registered Lease agreement, they have applied for transfer of
registrations of above mentioned 161 products from M/s. Breeze Pharma (Pvt)
Limited, Islamabad to their name and deposited an amount of Rs.3,320,000/-, as the
required fee in the DRAP account.
M/s. ICI Pakistan Limited, Karachi later informed that as the Central Licensing Board
vide its orders communicated under letter dated 4th February, 2014, decided that
instead of transfer of DML No.000659 (Formulation) M/s. ICI Pakistan Limited shall
apply for grant of fresh DML after surrendering of Licence and Inspection Book issued
to M/s. Breeze Pharma (Pvt) Limited, Islamabad, so their application for transfer of
registration has been rendered redundant and stands effectively aborted, as neither of
the parties agrees to such terms and the same would cause a drastic shortage of the
concerned drugs in the market against the spirit and requirements of the law and
relevant rules. They have therefore requested that the amount of Rs.3,320,000/-
deposited as above be refunded and returned to them to foreclose the issue.
The applications for the grant of registrations are submitted under rule 26 of the Drugs
(Licensing, Registering & Advertising) Rules, 1976. The fee is deposited under sub-
rule 3 of the rule 26. The Rule 26 (6) stats “Any Fee deposited under sub-rule (3) shall
not be refunded”. Moreover, the applications were submitted for transfer of
registration which can not be approved as the central licensing Board has not acceded
to their request.
Registration Board in its 245th meeting held on 29-30th September, 2014, after detailed
deliberations and keeping in view decision of the Central Licensing Board rejected the
applications of M/s. ICI Pakistan Limited, Karachi for transfer of registrations of 161
products from M/s. Breeze Pharma (Pvt) Limited, Islamabad to their name.
The proceedings, observation and decision of the Appellate Board is as under:-
The appellant submitted the following arguments, as already stated in their appeal that:
i. They never applied for transfer of registration. They applied for grant of
registration.
ii. Against their request for refund of fee, they received letter that the Registration
Board has rejected their applications for transfer of registration of 161 products.

iii. They were trying to acquire a running business.
iv. Sub-Rule (3) of rule 26 of the Drugs (Licensing, Registration & Advertising)
Rules, 1976, which stipulates that the fee deposited in no case be refunded, stood
omitted by SRO 662(I)/2005 dated 25-06-2005.
v. Why their application submitted in 2013 were considered while applications for
registration of January, 2011, were pending.
b. The respondents stated that the firm applied for the transfer registrations to the 161
products, which were registered in the name of Breeze Pharma (Pvt.) Ltd; to their name. Refund
is not allowed under rule 26 (6) of the Drugs (Licensing, Registration and Advertising) Rules,
1976.
c. The Board observed that:
i. No explicit decision was made by the Registration Board on the specific of the
Appellant for refund of the fee.
ii. The Appellant prematurely applied for transfer of grant of registration, as the case
may be, before the final decision on their request by the Central Licensing Board.
iii. Appeal was applied based on a decision communicated vide letter No.F.3-4/2014-
Reg-I(M-245) dated 06-11-2014, wherein their request for transfer of registration
of 161 products from M/s. Breeze Pharma (Pvt.) Ltd; Islamabad to their name was
rejected. But the Appellant was contesting their request of refund instead of
rejection of their request for transfer.
Decision of Appellate Board:-
In light of the above, the Board decided to remand back the case to Registration Board
for precise and specific decision on the request of the Appellant for refund of their fee. The
Registration Board in its 259th meeting deferred the case for having clear rule positions
particularly with reference to issue of refund of registration fee.
The applications for the grant of registrations are submitted under Rule 26 of the Drugs
(Licensing, Registering & Advertising) Rules, 1976. Earlier, the fee was deposited under Sub-
rule 3 of the Rule 26 which specify registration fees to be submitted. The Sub-rule 3, however,
was omitted vide SRO 662(I)/2005 dated 25-06-2005, while the Sub-rule 6 of Rule 26, which
states that “Any Fee deposited under sub-rule (3) shall not be refunded”, is intact.
Decision: Registration Board observed that sub-rule 3 of Rule 26 of Drugs (Licensing,

Registering & Advertising) Rule 1976 can not be read in isolation. Sub-rule 3
is an integral part of Rule 26 and also referred in sub-rule 3(b). When sub-
rule 3 was omitted, a consequential amendment was to be made in sub-rule 6
where the reference of sub-rule 3 should have been substituted with the
reference to sub-rule 3(b). This consequentianal amendment was not carried
out which is very nominal consequential omission and does not render the
contents of sub-rule(6) in-effective. Therefore, the fee is not to be refunded as
the applications have already been rejected by Registration Board.

Case No.07: Show cause notices issued to the firms having registration of products
containing Ciprofloxacin for veterinary use.
The Registration Board in its 249th meeting had decided to issue show cause
notices for cancellation of all the drug formulation having Ciprofloxacin for veterinary use for
the reason of development of resistance in human. Accordingly show cause notices were issued
to the firms having registrations of aforementioned drug formulations. A number of firms have
responded with their point of view including request for personal hearings.
The case was placed before the Registration Board in its 257th meeting and the Board
directed to place comments of all firms / stake holders before the Board in its next meeting.
Accordingly the responses of the firms are being placed before the Board. The salient points, of
the responses received are summarized as under:-
i) The Board may considered taking legal measures to avert unnecessary use and
ensuring compliance of withdrawal period after treatment.
ii) Opinion of technical expert/veterinary expert committee may be taken before
making any decision in this regard.
iii) Transfer of drug resistance from animal bacteria to human bacteria is not reported
strongly.
iv) Putting ban on over the counter sale of such antibiotic.
v) Under Section 7 (11) of Drugs Act, 1976, detail of the, information or enquiry
conducted or comprehensive data/record/documents, on the basis of which the
decision was taken, may be communicated for response.
vi) A few firms also agreed to withdraw and requested for grant of registration of
other products.
vii) Most of the firm requested for opportunity for personal hearing.
Registration Board deferred the case in its 258th meeting due to paucity of time. The case
was again taken by in its 259th meeting held on 30th -31st May, 2016 and the Board decided to
call the firm's having registration of such products for personal hearing.
Notices for personal hearing to the firms have been issued.
Decision: Representatives of M/s. Tarobina Corporation, SB Pharma, Bio Labs,

Vetcon Pharmaceuticals, Attabak Pharmaceuticals, Cheris Pharma, and
Grand Pharma appeared before the Board. The firm representatives were of
the view that there is need together credible scientific data for establishing
the claim of development of resistance in human due to veterinary use of
ciprofloxacin. However, firm’s representatives agreed to proposal of de-

registration as the drug is not used in veterinary practices in reference
countries. They further requested that in order to save from financial losses
may be given sufficient time to liquidate the existing stocks and substitute
registration of another product may be given to them on priority. Keepining
in view above discussion, the Board in princiale agreed to de-register all the
products having Ciprofloxacin for veterinary use. However modalities for
implementation to this effect will be further deliberated in forthcoming
meeting.
Case No.08: Request for Registration of Drug(s) under Drug Act, 1976 by M/s. Unicare
Enterprises, Faisalabad.
The Registration Board in its 237th meeting held on 26-02-2013 constituted a sub-
committee for evaluation of applications of veterinary product for ensuring completion of codal
formalities. The Board further authorized Chairman, Registration Board for taking decision on
recommendations of the committee.
The sub-committee in its meeting held on 25-04-2013 approved the following products of
M/s. Unicare Enterprises, Faisalabad, manufactured by M/s. Laboratorios Karizoo S.A. Caldes
De Montbui, Barcelona, Spain, subject to inspection of manufacturer abroad, verification of
storage facilities as per policy:-
S. No. Name of Drug(s) Demanded Demanded

Pack sizes Shelf life
1. Lincosol 40% Oral Powder Decontrolled 03 years
Each gm contains:- 100gm
Lincomycin (as lincomycin 500gm
hydrochloride)…………400mg 1 Kg
(Antimicrobial). 2.5 Kg
5 Kg
10 Kg
2. Kariflox 10% Oral Solution Decontrolled 03 years
Each ml contains:- 1 Liter
Enrofloxacin…100mg/ml solution 5 Liter
(Antimicrobial). 10 Liter
25 Liter
3. Amoxicilina 500 Karizoo Decontrolled 02 years
Each gm contains:- 200gm
Amoxicillin Trihydrate….500mg 400gm
(Antimicrobial). 1 Kg
2.5 Kg
5 Kg
10 Kg

The firm has deposited fee of Rs. 1,00,000/- per product. The storage facility of the
importer has already been verified by the Area FID and as per new Import Policy of Medicine,
the product approved by regulatory authorities of Western European counties including Spain
may be exempted from inspection of manufacturing facilities.
While processing M/s. Unicare Enterprises, Faisalabad request for issuance of registration letter
of above drugs, it was noted that the pack sizes mentioned on CoPP are as under:-
Lincosol 40% Oral Powder 100gm, 1Kg

Kariflox 10% Oral Solution No pack size mentioned
Amoxicilina 500 Karizoo 200gm, 400gm & 1Kg
While the firm has demanded no of pack sizes which are not included in the CoPP of
exporting country.
The case was considered in 259th meeting of the Registration Board and the Board
decided as under:-
a. Approved the pack size of the products which are already mentioned in their CoPP.
b. For pack sizes not mentioned in the CoPP, the Board deferred the case for further
deliberation.
With reference to Kariflox 10% Oral Solution the firm has now submitted a copy of
Summary of Products Characteristics (SPC) which it claims to be part of CoPP. As per clause 6
of SPC the packs sizes of 250ml, 1 Liter 5 Liter are mentioned. The firm has requested to grant
them the same packing.
Decision: Registration Board decided as under:-

i. For the product Kariflox 10% Oral Solution, the pack size mentioned
in SMPC i.e. 250ml, 1 liter and 5 liters is approved.
ii. It was also decided that in future the pack size approved by the
reference regulatory authority, or those approved by the regulatory
authority of exporting country as mentioned in CoPP, SMPC shall be
considered for approval.

Case No.09: Request for Registration of Surgical Sutures by M/S. Zenith
International, Karachi.
Registration Board in its 243rd meeting deferred following products for expert opinion.
1. M/s. Zenith “Trugut” Chromic Catgut As per PRC 05 Rs.15000 +

International, (Absorbable Surgical Suture years
Karachi. / U.S.P) (With or Without Rs.85000 =
Needle) (All sizes) Rs.100000/-
Manufactured by
M/s. Sutures (Surgical Suture).
India (Pvt) Ltd.
Bangalore, India.
The product, however, was not sent for expert opinion as the firm did not provide the EC
certificate. The firm subsequently claimed that EC Authority do not issue CE certificate to any
manufacturer for Chromic Catgut since several years. They further claimed that their principal is
exporting this product to USA. The Board in 254th meeting, while considering the case, advised
that the firm should provide an appropriate certificate from the concerned regulatory authority as
evidence of it’s free sale.
The firm later provided a legalized and attested free sale certificate issued by Indian
authorities. The case was considered in the 259th meeting the Registration Board and the Board
deferred the case for confirmation of importability from India as per Import Policy Order, 2106.
The product is not included in the list of items not importable from India.
Decision: Registration Board decided to defer the case for ascertaining the approval
status by reference regulatory authorities. Moreover, the sizes also need to be
specified and clarification is required with regards to differentiation of the
sutures with needle and without needle.
Case No.10: Deferred drugs for expert opinion regarding for the use of formulation of
phenylbutazone.
Registration Board in its 257th meeting held on 24-25th March, 2016 deferred following
case for taking expert opinion of veterinary experts regarding use of the formulation in veterinary
practice.

S. Name of Name of Drug (s) Demanded Shelf
N
Manufacturer Composition & Life
o Therapeutic Group. Price &
Pack Size.
1. M/s Prix Pri-Phen 20 Injection 50ml 02
Pharmaceutica years
(Pvt) Ltd. Plot # Each ml injection contains:-
5 Pharmacity, 30- Phenylbutazone.…….200mg
Km Multan
(NSAID)
Road, Lahore.
The opinion of the experts is as under:-
Prof. Dr. M. Shoaib Akhtar, Prof. Dr. Muhammad Ashraf Brig (R). Dr.
Professor of Pharmacology, (T.I), Muzammil Hasan
Faculty of Pharmacy, Najmi,
University of Sargodha. Professor of Emeritus, Associate Dean,
Basic Sciences
Department of Pharmacology
Division, Foundation
and Toxicology,
University Medical
University of Veterinary College, Rawalpindi.
Animal Sciences, Lahore.
According to the published i) Phenylbutazone is a Awaited.

literature Phenylbutazone has nonsteroidal anti-
been one of the earliest inflammatory drug with
NSAIDS approved for use in same indications as
horses and dogs for the relief of other NSAIDs.
the relief of inflammatory ii) In veterinary practice it
conditions associated with the is quite effective and is
musculoskeletal system. It is commonly used in
available in the form of tablet, horses.
paste gel and parenteral iii) FDA also has approved
(injectable) formulations. its preparations for use
However, there is no in Horses and Dogs.
Phenylbutazone product for iv) The drug is not for use
approved use in food animals in in cattle/buffalo/sheep/
USA. But it can be used as goat as zero tolerance
extra label drug in dairy cattle policy in meat/milk/eggs
as well in less than 20 months due to chances/ problem
old animals. of lethal idiosyncrative
Therefore, keeping in view the agranulocytosis by
literature attached, I feel like Phenylbutazone reported
recommending the use of this in human.

drug formulation (Pri-Phen 20 v) Phenylbutazone is
Injection) use in veterinary banned for use in any
practice, especially in equines, animal intended for
cats and dogs. However, when human consumption
used in food producing species, because it causes serious
the withdrawal time periods and lethal idiosyncratic
must be taken care due to the adverse effects in
toxicity problems associated human.
with the drug residues. vi) Effect of
Phenylbutazone is bone-
marrow toxicity, leading
to agranulocytosis.
vii) Product "Pri-Phen 20
Injection" may be
approved for use in
equines and dogs only.
The Registration Board deferred the case in its 259th meeting for confirmation of
approval status by reference regulatory authorities.
As per information available on the website Phenylbutazone is not permitted for use in
food producing animals by USFDA and EMA.
Decision: Registration Board, in view of the expert opinion and status of use of
phenylbutazone in reference regulatories authorities decided as under:-
i. Rejected the application of Pri-Phen 20 Injection as drug is not
recommended for use in food producing animals.
ii. Issue show cause notices to all registered veterinary drug formulation
containing phenylbutazone.
Case No.11: Import of Phenylbutazone by M/S. International Pharma Labs. Lahore for
manufacturing of already registered drugs.
M/s. International Pharma Labs. Lahore has informed that their imported consignment of
Phenylbutazone raw material for manufacturer of their registered drug Phenylbutazone Injection
(Registration No.041231) has been withheld by the Assistant Drugs Controller, Lahore office
with the advise to get clarification from DRAP on whether use of Phenylbutazone in veterinary
product has been discontinued or not. The firm has requested for necessary clarification.

As per record of this office no formal instruction has been issued for discontinuation of
Phenylbutazone for veterinary use. However, the product is under review by the Registration
Board alongwith number of other veterinary drugs but, so far, no decision has been taken.
Since 218th meeting held 2009, the Registration Board used to refer the cases of
combinations, containing Phenylbutazone, to the Veterinary Expert Committee. As per available
record of VEC meetings (74th to 76th meeting) no recommendations were finalized.
The Registration Board in its 259th meeting deferred the case till decision of preceding case.
Decision:- Registration Board decided to defer the case till finalization of under
consideration issue of the registration of phenylbutazone containing
products.
Case No.12: Lack of interest for getting registration of approved oncology products by
M/S. Novartis Pharma, Karachi.
The Registration Board in its 236th meeting held on 20th November, 2012
approved the registration of following imported drugs in the name of M/s. Novartis Pharma
(Pakista) Limited, Karachi Manufactured by firm as mentioned in column II subject to inspection
of manufacturer abroad, verification of storage facilities and price fixation / calculation etc, as
per policy:-
S. No. Name of applicant & Name of Drug(s) Demanded Shelf Remarks

Manufacturer Price life
1. M/s. Novartis Pharma Oxaliplatin “Ebewe” Rs.30000/ Per 03 Rs.28,500/ Per vial
(Pakistan) Limited, 150mg Injection vial years
Karachi. / Each vial contains:- 7th DPC (DRAP)
M/s. Ebewe Pharma Oxaliplatin…150mg Complete address
Ges.m.b.H. Nfg. KG (Anticancer). of the manufacturer
MondseestraBe has been mentioned
Unterach, Austria. on registration letter
as per CoPP.

2. M/s. Novartis Pharma Neoflubin 50mg/2ml Rs.13262.70/1’ 03 Rs.9280.00/1’s
(Pakistan) Limited, injection s years
Karachi./ Each vial contains:- 14th DPC
M/s. Ebewe Pharma Fludarabine Complete address
Ges.m.b.H. Nfg KG Phosphate……50mg/2ml of the manufacturer
Unterach, Austria. (Anticancer). has been mentioned
on registration letter
as per CoPP.
3. M/s. Novartis Pharma Ebetrexat 2.5mg Tablets Rs.403.43/Per 03 The firm is not
(Pakistan) Limited, Each tablet contains:- 30’s years interested in the
Karachi./ Methotrexate registration.
M/s. Salutas Pharma Disodium….2.75mg
GmbH, Otto-von- (equivalent to 2.5mg
Guericke, Germany. Methotrexate)
License Holder:- (Anticancer Specialty)
M/s. Hexal AG,
Holzkirchen,
Germany.
4. M/s. Novartis Pharma Folcium 50mg/5ml Rs.1171.98/1’s 02 -do-

(Pakistan) Ltd, Injection years
Karachi. / Each 5ml ampoule
M/s. Ebewe Pharma contains: -
Ges.m.b.H Nfg. KG Folinic Acid as Calcium
MondseestraBe 11 Folinate......50mg.
AT-4866 Unterach
Austria. (Anticancer) not by FDA
& EMA

Karachi. / Each 10ml vial contains: -
M/s. Ebewe Pharma Folinic Acid as Calcium
Ges.m.b.H Nfg. KG Folinate......100mg.
MondseestraBe 11 (Anticancer Adjuvants)
AT-4866 Unterach
Austria.

Karachi. / Each 30ml vial contains: -
M/s. Ebewe Pharma Folinic Acid as Calcium
Ges.m.b.H Nfg. KG Folinate......300mg.
MondseestraBe 11 (Anticancer)
AT-4866 Unterach
Austria.
The firm later informed that they are only interested in registration of products at Sr. 1 &
2 above, and are not interested in the rest of the products.
Accordingly the registration letter of above 02 products have been issued, while the firms
intention for not getting registration of rest of the above products is submitted for consideration
of the Registration Board.
Decision:- As the product are important anti-cancer drugs, so the Board decided to ask
firm the reason / clarification for withdrawing registration of these products.
Case No.13: Request For Change Of Manufacturer Of Clipper Tablet (Reg.No.066104) By

M/S. Chiesi Pharmaceutical (Pvt.) Ltd, Lahore.
M/s. Chiesi Pharmaceuticals (Pvt.) Ltd; Lahore has applied for change of
manufacturer/manufacturing site for their following already registered imported human products,
as per details given below:-
S. Reg. No. Name of Products. Existing Approved New proposed site
No. sites
1. 066104 Clipper Tablets M/s. Chiesi M/s. DOPPLE
Each tablet contains:- Farmaceutici S.p.A, FARMACEUTICI
Beclomethasone Italy. S.R.L. con
Dipropionate ………. 5mg stabilimento sito in
VIA MARTIRI
DELLE FOIBE, 1-
29016
CORTEMAGGIORE
(PC) ITALIA.
The firm have deposited required fee of Rs.100, 000/- (Pages 60-61 & 83-84/Corr) and
submitted following supporting documents:-
ii) Copies of initial registration letter and the firm had applied within the validity of
registration on 21-06-2011.

iii) Fresh original & legalized CoPP from authorities of Italy for proposed
manufacturing site (Pages 100-102/Corr).
The firm have deposited required fee of Rs.100, 000/- and submitted following supporting
documents:-
ii) Copies of initial registration letter and the firm had applied within the validity of
registration on 21-06-2011.
iii) Fresh original & legalized CoPP from authorities of Italy for proposed
manufacturing site.
Decision: Registration Board deferred for confirmation of approval status in of

formulation by regulatory authorities of reference countries.
Case No.14 Request for change of manufacturer of Seroxat Tablet 20mg (Reg.No.
019501) by M/s. GlaxoSmithKline Pakistan Limited, Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi has applied for change of

manufacturer/manufacturing site for their following already registered imported human products,
as per details given below:-
S. No. Reg. No. Name of Products. Existing Approved New proposed site
sites
1. 019501 Seroxat Tablet 20mg M/s. S.C. Product License
Each tablet contains:- Europharma S.A. holder / marketing
Paroxetine HCl …… 20mg Brasov Romania. authorization
holder:
M/s. Smithkline
Beecham Limited,
980 Great West
Road, Brentford,
Middlesex, TW8
9GS, United
Kingdom.
Manufacturer
/Packagers:
M/s.
Glaxosmithkline
Pharmaceuticals
S.A. Ulica
Grunwaldzka 189,
Poznan, PL-60-
322, Poland.

The firm have deposited required fee of Rs.100, 000/- and submitted following
supporting documents:-
ii) Copies of initial registration letters & renewal status. (265-270/Corr).
iii) Original & legalized CoPP from Medicine and Healthcare Products Regulatory
Agency of UK for proposed manufacturing site (Pages 272-297/Corr).
The firm have deposited required fee of Rs.100, 000/- and submitted following supporting
documents:-
ii) Copies of initial registration letters & renewal status.
iii) Original & legalized CoPP from Medicine and Healthcare Products Regulatory
Agency of UK for proposed manufacturing site.
Decision:- Registration Board approved change of manufacturing site and product

license holder of Seroxat Tablet 20mg (Reg.No. 019501) as under:-
Product License holder:
M/s. Smithkline Beecham Limited, 980 Great West Road, Brentford,
Middlesex, TW8 9GS, United Kingdom.
Manufacturer & Packagers:
M/s. Glaxosmithkline Pharmaceuticals S.A. Ulica Grunwaldzka 189, Poznan,
PL-60-322, Poland.
Case No. 15. Request of M/S. CCL Pharmaceuticals (Pvt.) Ltd., Lahore for change of
manufacturing sites of their registered drug(s).
M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore have requested to approve the change of
manufacturing site of their following registered imported anti-cancer products form M/s.
Laboratorios IMA S.A.I.C (Palpa 2870, CABA) Argentina to M/s. Glenmark Generics S.A.
Calle 9 Ing Meyer Oks N° 593 (B1629MAX) Parque Industrial Pilar, Buenos Aires, Argentina:-
S. No. Reg. No. Name of drug(s) & Composition.

1. 044851 Toxiplatin 150mg Injection
Carboplatin ……….150mg
2. 044852 Toxiplatin 450mg Injection
Carboplatin ……….450mg
3. 052286 Cytotecan Injection 40mg
Each 2ml vial contains:-
Irinotecan Hydrochloride Trihydrate 40mg

M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore have deposited fee Rs.50,000 + 50,000 =
3,00,000/- and submitted following supporting documents:-
i) Copies of initial registration letters.

ii) Copy of change of manufacturer name from M/s. Servycal S.A., Argentina to
M/s. Glenmark Generics S.A., Argentina.
iii) Copies of last renewal.
iv) Original and legalized approval from regulatory authority of Argentina.
v) Copy of GMP Certificate.
vi) Original & Legalized Certificate of Pharmaceutical Products.
vii) Applications on Form 5-A.
viii) Credentials of the Manufacturer.
ix) Site Master File.
x) Copy of NOC for CRF.
M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore initially submitted Rs.50, 000/ per
products claiming that these are not available locally. However, later the firm has submitted the
balance fee Rs.50, 000/- per products also.
Decision: As the proposed change has been approved by the regulatory authority of
exporting countries, so the Board approved change of manufacturing site of
above products from M/s. Laboratorios IMA S.A.I.C (Palpa 2870, CABA)
Argentina to M/s. Glenmark Generics S.A. Calle 9 Ing Meyer Oks N° 593
(B1629MAX) Parque Industrial Pilar, Buenos Aires, Argentina subject to
inspection of manufacturer abroad as per policy on same terms & condition.
Case No.16: Request of M/s. Ghazi Brothers, Karachi for change of name of
manufacturer/manufacturing sites of their registered drug(s).
M/s. Ghazi Brothers, Karachi has applied for change of name of manufacturers for their
following already registered products as under:-
S. Reg. Name of Existing Name Requested changes
No. No. Drugs/Composition
1. 046647 Neomix 325 Soluble M/s. Pfizer Suzhou M/s. Zoetis Suzhou
Powder Animal Health Manufacturing Co.
Each gm contains:- Products Co. Ltd., Ltd., No.180 Zhu
Neomycin China. Yuan Road, Suzhou
Sulphate…….715mg New District,
(equivalent to Jiangsu, China.
Neomycin base
500mg)

2. 044992 Excede Injectable M/s. Pharmacia & M/s. Zoetis Inc.
Each ml contains:- Upjohn Company, 2605 East Kilgore
Ceftiofur crystalline Subsidiary of Pfizer Road, Kalamazoo,
free acid equivalent Inc. USA. Michigan, 49007,
to 200mcg Ceftiofur USA.
in a Miglyol and
cottonseed oil based
suspension
The firm has further requested for change of manufacturing site of their registered
products Draxxin Injection as per following details:-
S. Reg. Name of Existing Source Requested/proposed

No. No. Drugs/Composition changes
1. 044919 Draxxin Injection M/s. Pfizer Global M/s. Laboratorios
Each ml contains:- Manufacturing, Pfizer Ltda
Tulathromycin….100mg France. Guarulhos, Avenida
Monothioglycerol…5mg Presidente Tancredo
de Almeida Neves,
1555 Guarulhos, SP
P.P. Box 017112-
070 Brazil.
The firm have deposited required fee Rs.100,000 x 3 = Rs.300,000/- and submitted following
supporting documents:-
i) Application on Form-5A.
ii) Copies of initial registration letters.
iii) Copies to renewal status.
iv) Original & Legalized CoPP's for Neomix 325 Soluble Powder (China), for Excede
Injectable (USA) for Draxxin 100mg injection (Brazil)
v) Copy of GMP Certificate for Neomix 325 Soluble Powder) for Excede Injectable &
for Draxxin 100mg injection.
vi) NOC for (Draxxin 100mg Injection).
vii) Site master plans of concerned firms (Draxxin 100mg injection).
Decision: Registration Board decided as under:-

i. For Neomix 325 Soluble (Reg.No.046647), approved change of the name of
manufacturer from M/s. Pfizer Suzhou Animal Health Products Co. Ltd.,
China to M/s. Zoetis Suzhou Manufacturing Co. Ltd., No.180 Zhu Yuan
Road, Suzhou New District, Jiangsu, China on same terms & conditions.
ii. For Excede Injectable (Reg.No. 044992), approved change of the name of
manufacturer from M/s. Pharmacia & Upjohn Company, Subsidiary of

Pfizer Inc. USA to M/s. Zoetis Inc. 2605 East Kilgore Road, Kalamazoo,
Michigan, 49007, USA on same terms & conditions.
iii. For Draxxin Injection (Reg.No. 044919), approved the change of

manufacturing site from M/s. Pfizer Global Manufacturing, France to
M/s. Laboratorios Pfizer Ltda Guarulhos, Avenida Presidente Tancredo
de Almeida Neves, 1555 Guarulhos, SP P.P. Box 017112-070 Brazil
subject to inspection of manufacturer abroad on same terms &
conditions.

Registration-IV
Case No.17: Registration of Drugs For Export Purpose.
The following firm has applied for registration of drugs for the purpose of export only:-
S. # Name of Name of Drug (s)/Composition.

Manufacturer
1 M/s. Fassgen Valdis Tablets
Pharmaceuticals, Each film coated tablet contains:-
Hattar Ledipasvir…………………90mg
Sofosbuvir……………….400mg
The firm submitted all the relevant documents along with the fee of Rs.20,000/- per
product and requested for registration of drugs for export purpose only.
Decision: Registration Board approved above product for export registration.

However firm will deposit remaining balance Fee of Rs. 30,000/- and
Chairman, Registration Board will permit issuance of registration letter.
Registration is subject to following conditions:
 Manufacturer will export the product after complying all the

requirements as required under Drug Act, 1976 and relevant rules
including No objection certificate from concerned DRAP office.
 Manufacturer will also furnish export documents endorsed from custom
authorities (if required for any query) in order to ensure the export of the
product.
Case No.18: Request of M/s. Welmed Pharmaceuticals Gadoon for extension in contract
manufacturing permission.
Registration Board in 254th meeting deferred following application of M/s. Welmed

Pharmaceuticals Gadoon Swabi for extension of contract manufacturing period (where contract
manufacturer was also changed) for confirmation of already extended contract manufacturing
permissions.

S.No Name of Existing Reg.No Name of Product Date of Remarks
Applicant manufacturer applicatio
ns/Fee
1. M/s. Welmed M/s. 056233 W-Pime 500mg Injection 30-06-2015 30-06-2015
Pharmaceutical Welmark Each vial contains:- Dy No.66 Firm has
Gadoon Swabi. Hattar Cefipime….500 mg Rs.50,000/- requested
(USP Specification) for
change of
contract
manufacturer
to Bio-Lab
(Pvt) Ltd.,
Islamabad
2. -do- -do- 056234 W-Pime 1 gm Injection 30-06-2015 -do-

Each vial contains:- Dy No.69
Cefipime…………1 gm Rs.50,000/-
(USP Specification)
3. -do- -do- 056238 Mectrum 1gm Injection 30-06-2015 -do-

Cefoperazone Sodium Rs.50,000/-
≡ Cefoperazone.500 mg
Sulbactam …….500mg
(Welmark Specification)
4. -do- -do- 056239 Mectrum 2 gm Injection 30-06-2015 -do-

Cefoperazone Sodium Rs.50,000/-
≡ Cefoperazone.1000 mg
Sulbactam ….1000mg
(Welmark Specification)
The firm subsequently requested that they would like to exclude the products Medifotax
Injection 500mg & 1gm, contract manufacturing permission for which has already been given
from M/s. Mediate Pharmaceuticals, Karachi and they may be granted extension/change of
manufacturer permission of above products instead. The case was considered in 258th meeting
and deferred on the ground that the firm has not made any specific request for withdrawal /
cancellation of their products Medifotax Injection (500mg & 1gm), so matter needs to be
clarified from the firm. The case is accordingly deferred.
Now the firm stated to cancel the registration of Medfotax Injection (Cefotaxime 500mg,

1gm) (Reg.No. 056228, 056229) and issue the extension letter of above mentioned drugs.
The firm has only two Sections and it, therefore, entitles to contract manufacturing of 10
products as per policy of 5 products per section. So far the firm has been granted registration of 8
products.
Decision: Registration Board did not agree to the firm’s proposal for withdrawal /
cancellation of their already registered two products for making way to get
the approval of fresh one as replacement. The Board further decided to allow
permission for extension of contract manufacturing alongwith change of
manufacturer (from M/s. Wnsfeild Pharmaceuticals Hattar to M/s. Bio-Labs,
Islamabad) for only two of the above mentioned products of firm choice till
30.06.2020. The Chairman Board was authorized to allow issuance of
permission letter after taking firm’s choice for the products.
Case No.19: Registration of Frodine Syrup.
Registration Board in 243rd meeting held on 9th May, 2014 deferred following drug of
M/s. Wisdom Pharmaceuticals, Peshawar for confirmation of controlled drug section and
international availability of the product
M/s. Wisdom Frodine Syrup

1 Pharmaceuticals, Each 5ml contains:-
Peshawar Pholcodine……………….….5mg
Chlorpheniramine Maleate…..2mg
Registration Board in 250th meeting considered the comments of review committee and
decided as under:-
International availability Remarks
BRONCALENE ADULTES Chlorphénamine (maléate de) ;

chlorphénamine (maléate de) ; pholcodine
pholcodine Adults:
0,01300g/100 ml (0.65mg/5ml); Dose: 0.01300g/100 ml (0.65mg/5ml);
0,08g/100ml (4mg/5ml) 0.08g/100ml (4mg/5ml)
Oral Syrup 0.0133gm/100ml (0.665mg/5ml);
0.08g/100ml (4mg/5ml) (sugar free
sweetened with saccharine sodium)
Children: 0.01gm/100ml (0.5mg/5ml);
0.05g/100ml (2.5mg/5ml)
(Ref: ANSM France)

Decision of 250th Registration Board meeting :
i. Applicants shall shift their formulation as per formulation approved in ANSM France (new
registration application with complete fee) if manufacturing facility is approved by CLB.
ii. For already registered drugs, same procedure as mentioned above (at Sr. No. i) shall be
adopted.Otherwise show cause notices shall be issued for deregistration of drugs in this
formulation.
iii. All such application shall be processed on priority basis.
Now M/s. Wisdom Pharmaceuticals Peshawar has made an application with the revised
formulation alongwith complete fee of Rs.20000/- . The revised formulation is as under:-
1 M/s. Wisdom Frodine Syrup

Pharmaceuticals, Each 5ml contains:-
Peshawar Pholcodine……………….….4mg
Chlorpheniramine Maleate…..0.65mg
Decision: Registration Board decided to approve the change in formulation of Frodine

Syrup in accordance with the revised standard formulation.
Case No.20: Request of firms for issuance of registration of deferred drugs.
The following registration applications of various firms were deferred by Registration

Board meetings in its 234th meeting for the reason mentioned against each.
1. M/s. Winbrain Razole 20mg Tablets 10’s As Per Deferred as per policy of 5
Research Each tablet contains:- SRO products per section for new
Laboratories, Omeprazole…….20mg license/new section (product is
Hattar (Proton Pump Inhibitor) recommended by the me-too
1. Tablet General committee)
2. Caps General,
3. Dry powder
Susp General
2. -do- Diclo-K 50mg Tablets 2x10’ As Per Deferred as per policy of 5

Each tablet contains:- s SRO products per section for new
Diclofenac license/new section (product is

Potassium……50mg recommended by the me-too
(Analgesic) committee)
3. -do- Diclo-K 75mg Tablets 2x10’ As Per Deferred as per policy of 5

Each tablet contains:- s SRO products per section for new
Diclofenac license/new section (product is
Potassium……75mg recommended by the me-too
committee)
4. -do- Pepzole 40mg Tablets 14’s As Per Deferred as per policy of 5
Each tablet contains:- SRO products per section for new
Pantoprazole (as license/new section (product is
Sodium recommended by the me-too
Sesquihydrate)…40mg committee)
5. -do- Lodepress 20mg Tablets 10’s As Per Deferred as per policy of 5

Each tablet contains:- SRO products per section for new
Paroxetine as license/new section (product is
HCl…..20mg recommended by the me-too
(Antidepressant) committee)
6. -do- Am-Telma 5/40mg 14’s As Per Deferred as per policy of 5
tablets SRO products per section for new
Each tablet contains:- license/new section (product is
Amlodipine………5mg recommended by the me-too
Telmisartan……..40mg committee)
(Antihypertensive)
7. -do- Loxit 60mg Capsules 10’s As Per Deferred as per policy of 5

Each capsule contains:- 14’s SRO products per section for new
Duloxetine as license/new section (product is
HCl….60mg recommended by the me-too
8. -do- Gabapen 300mg 10’s As Per Deferred as per policy of 5
Capsules SRO products per section for new
Each capsule contains:- license/new section (product is
Gabapentin……100mg recommended by the me-too
(Anticonvulsant) committee)
9. M/s. Weather G-Pentin 300mg Capsule 10’s -do- Deferred as per policy of 5
Folds Each capsule contains: - products per section for new
Pharmaceuticals, Gabapentin …… 300mg license/new section (product is
Hattar (Analgesic) recommended by the me-too
1. Dry powder committee)
Susp General,
2. Caps, General
10. -do- Effexor 75mg Capsule 10’s -do- Deferred as per policy of 5
Each capsule contains:- products per section for new
Venlafaxine HCl 75mg license/new section (product is

(Psychotherapeutic) recommended by the me-too
committee)
11. -do- Tizadine 6mg Capsule 10’s -do- Deferred as per policy of 5
Tizanidine …….. 6mg license/new section (product is
(Muscle relaxants) recommended by the me-too
committee)
12. -do- Helcobal 500mcg 10’s -do-` Deferred as per policy of 5
Capsule 10x1 products per section for new
Each capsule contains:- 0’s license/new section (product is
Mecobalamine. 500mcg recommended by the me-too
(Coenzyme-type vitamin committee)
B12)
13. -do- Floxapen 250mg Capsule 10’s -do- Deferred as per policy of 5
Flucloxacilline .. 250mg license/new section (product is
(Pencillin) recommended by the me-too
committee)
14. -do- D-Lox 30mg Capsules 14’s As Per Approved
Each capsule contains:- SRO
Duloxetine as
HCl.30mg
(Antidepressant)
15. -do- D-Lox 60mg Capsules 10’s As Per Deferred as per policy of 5
Each capsule contains:- 14’s SRO products per section for new
Duloxetine as license/new section. (product is
HCl.60mg recommended by the me-too
16. -do- Artham DS Capsule 8’s -do- Deferred as per policy of 5

Artemether …… 40mg license/new section (product is
Lumefantrine ….. 240mg recommended by the me-too
(Anti-malarial) committee)
17. -do- Ciprofold 250mg Capsule 10’s -do- Deferred as per policy of 5
Ciprofloxacin as HCl. license/new section (product is
250mg recommended by the me-too
(Anti infective committee)
Quinolones)
18. -do- Tranxam 500mg Capsule Not -do- Deferred as per policy of 5
Each capsule contains:- menti products per section for new
Tranexamic acid.. 500mg oned license/new section (product is
recommended by the me-too
committee)

19. -do- Tranxam 250mg Capsule Not -do- Deferred as per policy of 5
Each capsule contains:- menti products per section for new
Tranexamic acid.. 250mg oned license/new section (product is
(Antifibrinolytic) recommended by the me-too
committee)
20. -do- P-Zole 40mg Capsule 14’s -do- Deferred as per policy of 5
Pantoprazole…… 40mg license/new section (product is
(Antipeptic ulcerants) recommended by the me-too
committee)
21. M/s. Welwrd Artiwel 280mg Tablets 8’s As Per Deferred as per policy of 5
Pharmaceuticals, Each tablet contains:- SRO products per section for new
Hattar Artemether……….40mg license/new section (product is
1. Dry Powder Lumefantrine……240mg recommended by the me-too
Inj. Sterile (Antimalarial) committee)
2. Tablet General
3. Capsule
General
4. Dry Powder
Suspension
General
5. Sachet General
22. -do- Estowel 10mg Tablets 10’s As Per Deferred as per policy of 5
Each tablet contains:- 14’s SRO products per section for new
Escitalopram (as license/new section (product is
oxalate).10mg recommended by the me
(Anti Psychotic)
23. -do- Weldiclof 100mg SR 2x10’ As Per Deferred as per policy of 5

Tablets s SRO products per section for new
Each film coated tablet license/new section (product is
contains:- recommended by the me-too
Diclofenac SR committee)
…..100mg
(NSAID)
24. -do- Lansowel 30mg Capsules 14’s As Per Approved with fulfillment of
Each capsule contains:- SRO requirements of source, GMP
Lansoprazole Pellets certificate, stability data and
equivalent to Fee. Rs.15000/-
Lansoprazole…30mg
(Proton Pump Inhibitor
25. -do- W-Pentone Injection Per As Per Highly sensitive product.

Each vial contains:- vial SRO Product specific inspection is
Thiopentone Sodium recommended by the experts.

..5.00mg
(Anesthetic agent)
26. -do- Zimtac 250mg Injection Per As Per Deferred as per policy of 5
I.V vial SRO products per section for new
Each vial contains:- license/new section (product is
Cefotaxime sodium recommended by the me-too
equivalent to committee)
Cefotaxime……..250mg
(Cephalosporin)
27. -do- Zimtac 500mg Injection Per As Per Deferred as per policy of 5
I.V vial SRO products per section for new
Cefotaxime sodium recommended by the me-too
Cefotaxime……..500mg
(Cephalosporin)
28. -do- Zimtac 1gm Injection I.V Per As Per Deferred as per policy of 5
Each vial contains:- vial SRO products per section for new
Cefotaxime sodium license/new section (product is
equivalent to recommended by the me-too
Cefotaxime……..1gm committee)
(Cephalosporin)
29. -do- Weltraxone 250mg Per As Per Deferred as per policy of 5

Injection IV vial SRO products per section for new
Ceftriaxone Sodium recommended by the me-too
Ceftriaxone ……250mg
(Cephalosporin)
30. -do- Weltraxone 500mg Per As Per Deferred as per policy of 5
Ceftriaxone ……500mg
(Cephalosporin)
31. -do- Weltraxone 1gm Per As Per Deferred as per policy of 5

Ceftriaxone …1gm

(Cephalosporin)
In 234th meeting the Board adopted 5 products per section policy and 5 products per section of
each firm were accordingly approved while rest of the applications were deferred. Subsequently
in 236th meeting 5 more products per section per firm were approved among the products
deferred in 234th meeting. The above products are the remaining applications which were left
after the approval of 10 products (in 234 & 236th meeting) as mentioned above paras.
The firms have requested for issuance of registration letters for the products at S.No.1-25
while for the products at S.No.26-31, the applicant M/s. Welwrd has not made any request.
As per record of the section number of registration granted to various sections of the
above firms is as under:-
Name of Firms Section Already registered
M/s. Winbrain Reserch Labs Capsules 8 products
M/s. Weather Fold Capsule 10 products
M/s. Welwrd Tablets 10 products

Pharmaceuticals,
Liquid Injectable 10 products
Capsule 8 products
Decision: Registration Board in principal agreed to allow two products in Capsule

Section of M/s. Welwrd Pharmaceuticals, Hattar from among their above
applications. The choices for the products are to be taken from the firm
before placing the case for consideration of the Board for final decision.
Remaining products will be taken up as per their turn.
The case of applications of M/s. Winbrain Research Laboratories, Hattar

was discussed alongwith following case No.21 and decision is recorded there
in.

Case No.21 Request of M/s. Winbrain Research Laboratories, Hattar for issuance of
registration letter.
M/s. Winbrain Research Laboratories, Hattar has requested for issuance of registration
letters of their following product approved in 234th meeting of Registration Board with
conditions mentioned against each .
S.No Name of Name of Products Pack Demand Dated Decision of

Manufacturer size ed MRP Registration
Board
1. M/s. Winbrain Brainzole 30mg 14’s As Per 2-6- Approved with
Research Capsules SRO 2011 fulfillment of
Laboratories, Each capsule contains:- requirements of
Hattar Lansoprazole Pellets source, GMP
1. Tablet equivalent to certificate,
General Lansoprazole…..30mg stability data and
2. Caps (Proton Pump Inhibitor) Fee. Rs.15000/-
General,
3. Dry powder
Susp General
2. -do- Esobrain 20mg Capsules 14’s As Per -do- Approved with
Each capsule contains:- SRO fulfillment of
Esomeprazole Pellets requirements of
equivalent to source, GMP
Esomeprazole….20mg certificate,
(Proton Pump Inhibitor) stability data and
Fee. Rs.15000/-
3. -do- Omebrain 40mg 14’s As Per -do- Approved with
Capsules SRO fulfillment of
Each capsule contains:- requirements of
Omeprazole Pellets source, GMP
equivalent to certificate,
Omeprazole……..40mg stability data and
(Proton Pump Inhibitor) Fee. Rs.15000/-
4. -do- Loxit 30mg Capsules 14’s As Per -do- Approved
Each capsule contains:- SRO
Duloxetine as
HCl….30mg
(Antidepressant)

The registration letter was not issued as the firm has not fulfillment the requirements while the
product as S.No.4 was referred for price fixation. The firm has now requested to issue registration
letter by providing the documents referred in the minutes. Moreover the price of product as S.No. 4
has also been fixed.
The firm already has registration of 8 products in the capsule section.

Decision: Registration Board in principal agreed to allow two products in capsule
section of M/s. Winbrain Research Laboratoire, Hattar from among their
above applications (referred in the instant case and case No.20). The choices
for the products are to be taken from the firm before placing the case for
consideration of the Board for final decision. Remaining products will be
taken up as per their turn.

Registration-V
Case No.22: Export of Non Me-Too Product
a. M/s. Highnoon Laboratories Ltd, Lahore
M/s. Highnoon Laboratories Ltd, Lahore has requested for registration of following
product for export purpose only:-
S. No Name of Products
1. Daploz 5mg Tablets
Each film coated tablet contains:
Dapagliflozin propanediol monohydrate equ to;
Dapagliflozin…………..5mg
2. Daploz 10mg Tablets
Dapagliflozin propanediol monohydrate equ to;
Dapagliflozin……….…..10mg
3. Cana 300mg Tablets
Canagliflozin hemihydrates equivalent to;
Canagliflozin…..……….300mg
4. Cana 100mg Tablets
Canagliflozin hemihydrates equivalent to;
Canagliflozin…..……….100mg
5. Daclata 60mg tablets
Daclatasvir dihydrochloride equ to:-
Daclatasvir……………...60mg
6. Daclata 30mg tablets
Daclatasvir dihydrochloride equ to:-
Daclatasvir……………..30mg
The firm has submitted the following documents.
a. Fee of Rs. 50000/- each product for this purpose.
b. Form-5.
c. Copy of GMP inspection.
d. Export orders.
c. NOC for CRF.
e. Approval of section by CLB.

Decision: Registration Board approved grant of above registrations exclusively for
export purpose. Registration is subject to following conditions:

product
b. M/s. CCL Pharmaceuticals (Pvt) Ltd , Lahore
M/s. CCL Pharmaceuticals (Pvt) Ltd , Lahore has requested for registration of following
product for export purpose only:-
S. No Name of Products
1. Carci Suspension 500mg/5ml
Each 5ml contains:
Carbocisteine…………..500mg
2. Carci Suspension 200mg/5ml
Each 5ml contains:
3. Carci Capsule 500mg
Each Capsule contains:
The firm has submitted the following documents.

a. Fee of Rs. 50000/- each product for this purpose.
b. Form-5.
c. Copy of GMP inspection.
d. Export orders.
c. NOC for CRF.
e. Approval of section by CLB.
Decision: Registration Board approved grant of above registrations exclusively for

export purpose. Registration is subject to following conditions:

product

Case No.23 Registration applications of M/S Gallop Water Sciences, Lahore deferred in
253rd meeting of Registration Board.
Following applications of M/s Gallop Water Sciences, Lahore were deferred in 253rd
meeting of registration board
1. G-SOL PAEDS Form-5 • Int availability Deferred for

IV Infusion Dy. No: 3472 not confirmed. confirmation of
Each 100ml contains: dated 18-05-  Me-too: Macsol approval by
Dextrose 2015 Paeds of M/s Mac reference
anhydrous….4.3g 20,000/- & Rains Lahore. regulatory
Sodium Rs.50/- Rs.40/- authority.
Chloride……..0.18g 500ml, 200ml
Caloric & Electrolytic
solution
2. G-Lyte M Form-5  Internationally, Deferred for
IV Infusion Dy. No: 3473 not available in confirmation of
Each 100ml contains: dated 18-05- this strength. approval by
Sodium 2015  Me-too: reference
Plabolyte-M of regulatory
Chloride……..0.216gm 20,000/- authority.
M/s Otsuka,
Potassium Rs.100/- Karachi
Chloride…..1.5gm Rs.70/-
Calcium Chloride 2 H2O 1000ml, 500ml,
…..…0.022
Sodium Acetate 3 H2O
…0.313gm
Dextrose………..5.0gm
Electrolytic & Caloric
solution
3. Mannitol Form-5  Internationally Deferred for
IV Infusion Dy. No: 3458 Not available in confirmation of
Each 100ml contains: dated 18-05- this strength approval by
Mannitol…….17.5gm 2015  Me-too: Mactol reference
of M/s Mac & regulatory
Sorbitol…….2.5gm 20,000/- authority.
Rains, Lahore
Osmotic diuetic Rs.200/- 500ml
Subsequently the firm requested for replacement of above applications with the following
new ones which were presented in 255th meeting of the board. Case was decided as follows:

566 G-SOL 10% Form 5 Otsuka The Board deferred the
Japan application for
Rs. 20,000/- formulation clarification whether the
vide Dy. No. (Pladix) firm wants to withdraw
Each 100 ml contains 1140 dated 06- their previously deferred
Dextrose anhydrous 10gm 11-2015 application in view of the
FDA newly submitted
approved applications or otherwise.
Caloric solution Pack size of Dextrose
1000ml / 70 10%
(Manufacture PKR
Specification) Medisol
10%
(Medipak)
567 G-SOL 5% Form 5 Otsuka The Board deferred the

Japan application for
Rs. 20,000/- formulation clarification whether the
vide Dy. No. (Pladix) firm wants to withdraw
Each 100 ml contains 1140 dated 06- their previously deferred
Dextrose anhydrous 5gm 11-2015 application in view of the
FDA newly submitted
approved applications or otherwise.
Caloric solution Pack size of Dextrose
500ml / 55 5%
(Manufacture PKR
Specification) Medisol 5%
(Medipak)
568 G-Sol RL 500 ml Form 5 MHRA The Board deferred the

approved application for
Each 100 ml contains Rs. 20,000/- clarification whether the
vide Dy. No. firm wants to withdraw
Sodium Chloride 0.60gm 1141 dated 06- their previously deferred
Potassium Chloride 11-2015 application in view of the
0.04gm Medisol newly submitted
Hartmann applications or otherwise.
Calcium Chloride Pack size of IV infusion
0.027gm 500ml / 56

Sodium lactate 0.32 gm PKR (Medisol )
Electrolyte Solution
(Manufacture
Specification)
The firm has requested that the registration of the products deferred in 253 rd meeting may
be considered in routine as per DRAP Policy and two products may be processed on priority
basis against the quota of ten products per section. This request of the firm was considered in
257th meeting of registration board and following decision was taken:-
Decision: Registration Board acceded to the request of the firm and approved products at
serial no. 559 and 560 whereas product at serial no 558 was deferred for clarification
whether the firm wants to withdraw their previously deferred application in view of the
newly submitted applications or otherwise.
It is submitted that a typographic error was made in the minutes of 257th registration
board meeting and products at Sr no. 559 and 560 was mentioned inadvertently instead of
product at Sr. No 567 & 568. The firm has been issued registration letter with correction in
minutes.
Decision: Registration Board noted the information and endorsed the action taken.
Case No.24: Pending registration of Vinqo 500mg & 1gm Injection of M/s Wilshire
Laboratories (Pvt) Ltd, Lahore.
Registration Board in 258th meeting discussed the following case of M/s. Wilshire
Laboratories (Pvt) Ltd, Lahore. Following products of M/s Wilshire Laboratories (Pvt) Ltd,
Lahore were discussed in 236th meeting of Drug Registration Board but deferred for further
clarification about manufacturing facility. Then the case was included in 243rd meeting of the
board again deferred for further clarification about the manufacturing facility.

S.No Product Name Generic Name Date of Remarks
Submission
1 Vinqo 500mg inj Vancomycin 04.06.2011 Applied as a new
Hydrochloride 500mg section product
2 Vinqo 1gm inj Vancomycin 04.06.2011 Applied as a new
Hydrochloride 1gm section product
Registration Board its 243rd meeting discussed the case and for further deliberation on
manufacturing area requirements.. Registration Board in its 248th meeting decided the
manufacturing Area requirement for Vancomycin:
“As it is not a Penicillin Derivative, hence manufacturers, having in-house lyophilization

facilities, may be allowed to produce it in General Injectable Area”
Decision: Registration Board deferred the case for getting details of manufacturing
process of the applicant and to decide the case in the light of decision taken by the board
in 248th meeting.
The above decision needs to be reconsidered as Registration Board in 257th meeting has
granted the same registration to M/s. Fynk Pharma, Lahore and referred decision of 248 th
meeting of the board is not the same as depicted in 258th meeting of the board. Rather, board in
2418th meeting had deferred the product for further deliberations.
Decision: Regsitration Board approved the above drugs in favour of M/s Wishire
Laboratories (Pvt) Ltd, Lahore.
Case No.25: Change of brand name for Epinol CF tablet of M/s. CCL Pharmaceuticals
(Pvt) Ltd; Lahore
M/s. CCL Pharmaceuticals (Pvt) Ltd: Lahore has requested for change of brand name of
their following product and they have informed that the proposed brand name already in syrup
form:-
S. No. Names of Drug(s) with Reg. No. New proposed names

formulation
1. Epinol CF Tablet 023982 Pulmonol CF Tablet

Each tablet contains:
Paracetamol……………500mg
Pseudoephedrine HCl….60mg

Chlorpheniramine
Maleate……….4mg
The management of the firm has submitted following documents:

i. Fee of Rs. 20,000/- for each product.
ii. Undertaking on stamp paper.
iii. Copies of initial letter of registration & renewal status.
iv. CRF clearance certificate.
It is submitted that the composition of Epinal tablets as mentioned above is different form
pulmonol syrup. Composition of pulmoul is as under.
S.No. Reg. No Name of Product with composition
1 000874 Pulmonol Syrup
Each 5ml Contains:-
Chlorpheniramine maleate B.P……5mg
Terpin Hydrate USP……………….10mg
Potassium Bicarbonate B.P………...0.1mg
Ammonium Chloride B.P…………..25mg
Menthol B.P………………………...1mg
Aminophylline Ph.Eur………………32mg
Potassium guaiacol sulfonate U.S.P…...5mg
Potassium citrate B.P………………..0.1mg
Tr. Senega B.P……………………….0.05ml
Tr. Ipecac B.P………………………...0.025ml
Extract Glycyrrhiza b.P………………..0.1ml
Flavor & Base……………..q.s
Decision: Registration Board considered the request of the firm in the light of SOPs /
guidelines for change of brand name of the drugs and did not accede to the
request as composition of formulation of the drug (Epinol CF Tablet) was
different from the composition of Pumonol Syrup.
Case No.26: Registration of M/S N.B.S Pharma, Lahore
Following products of M/s N.B.S Pharma, Lahore were considering 215th meeting of
registration board and decided as follows.
Sr.No Name of Drug Decision

1. Povidone-1 Solution Approved subject to the submission of
Each 100ml contains:- the last Inspection report.
Povidone Iodine USP 7.5gm equivalent to
0.75% available iodine (USP)

It is submitted that the above cases were discussed in 215th meeting of registration board
and decision of the board has been reflected in the above table. The firm has now submitted the
differential free of Rs. 12000 and submitted the inspection report dated 12.11.2014. which
shows details of the section as under:-
External Preparation Section:-
This section comprised of preparation and filling rooms, equipped with preparation
vessels of different sizes. Silver san mixer and filling machines was installed HVAC
system was provided in this area and was functional at the time of inspection. Re-packing
area was equipped with filling machine and different size vessels. HVAC system was
installed production area furnish with epoxy.
Decision: Registration Board deferred the case for GMP status of the firm and
confirmation of section either from Licensing division or from panel /
renewal inspection report.
Case No.27: Registration of M/s Chishti Pharma ; Sahiwal
M/s Chishti Pharmaceuticals Industries, Sahiwal has requested to issue following

registration approved in 206th meeting.

1. Imperial Crepe Bandage. Approved.
Contains:-
Crepe Bandage BPC.
The firm has submitted following documents :-
i. Copy inspection report (GMP)

ii. Copy of Bank challan of Rs. 8000/-
iii. Differential fee of Rs. 12000/-as balance fee.
Decision: Registration Board deferred the case for submission of new Form-5 and
verification of record regarding issuance of registeration letter, as product
was considered by Registration Board in 2007.

Case No.28: Registration Of M/S Schazoo Pharma, Lahore.
M/s the Schazoo Pharmaceuticals Laboratories (Pvt) Ltd, Sheikhupura had requested for
permission to export drugs containing precursor Chemical Ephedrine to M/s. Rahullah Nasrat
Limited, Afghanistan as detail below:-
S.No Name and composition Reg. No Pack Size Quantity Quantity of

requested to Ephedrine
export
1. Rhinosone-P Nasal Spray 040892 15ml 50000 Bottles 3.75-kg
Each 100ml Contains:-
Naphazoline
Nitrate…..125mg
Ephedrine HCl…..500mg
Prednisolone
Acetate….2.5mg
2. Rhinosone-P Nasal Spray 000834 15ml 100000 7.5-kg
Each 100ml Contains:- Bottles
Naphazoline
Nitrate…..125mg
Ephedrine HCl…..500mg
9 alpha- Fluoro
Prenisolone 21-
Acetate….2.5mg
The firm was asked for the clarification of the both compounds of Prednisolone . They
have replied with official reference i.e. The USP monograph of 9 Alpha-Floropredinsolone
Acetate shows it is an veterinary drugs but the ear drops applied by the firm are for human
consumption.Moreover, the subject formulation is not available in reference regulatory
authorities as specified by the board in 249th meeting.
Decision: Registration Board deferred the case for further deliberation and
presentation by the firm before Registration Board.

Case No. 29: Registration of M/S Dyson, Lahore
M/s. Dyson Pharma, Lahore has requested to issue following registration considered in
236th meeting.

1 Dyprog Tablets 5mg Approved subject to submission of
Each tablet contains:- comparative dissolution profile and
Norethisterone….5mg related documents. The firm shall be
B.P Specs granted non-anabolic steroids in this
section.
2 Dyston Tablets 10mg -do-
Each film coated tablet contains:-
Dydrogesterone….10mg
USP Specs
3 Dyestro Tablets 0.625mg -do-

Conjugated Estrogens …..0.625mg
USP Specs
4. Dyestadiol Tablets -do-

Cyproterone acetate….2mg
Ethinylestradiol….35mcg
The firm has submitted following documents:-
i. Differential Fee of Rs. 12000/per product

ii. Comparative dissolution profile
iii. Undertaking as per decision of Registration Board in 251st meeting.
Decision: Registration Board deferred the case for further deliberation in next
meeting.

Case No.30: Registration application of M/s. English Pharmaceutical, Lahore deferred in
241st meeting.
Registration Board in 241st meeting discussed the case of M/s English Pharma, Lahore
and decided as follows:-
M/s. English Pharmaceuticals Industries, Lahore were deferred in its 237th meeting for
verification of complete formulation with originator (Detrusitol Capsule SR 4 mg by Pfizer) and
Comparative Dissolution profile with originator.
Name of products & Composition Pack Demanded

size price
Terol 4mg SR Capsules 3×10’s Rs.2300/-
Each capsule contains:-
Tolterodine HCl equiv. to
Tolterodine SR…4mg
The firm has provided following documents:-
1. Comparative dissolution profile.

2. Sample of Detrusitol Capsule SR 4 mg by Pfizer confirming that product is I pellet
form
3. GMP certificate of manufacturer.
4. Stability studies.
5. Certificate of analysis.
Decision (241 meeting): - Registration Board deferred the submitted data to following experts for
evaluation and authorized its Chairman for decision on recommendation of experts:
I. Prof.Dr.mehmood Ahmad, Islamia university, Bahawalpur

II. Prof.Dr.Zafar Iqbal, University of Peshawar.
III. Director DTL, Lahore.
In view of above, experts have furnished comments as under:-
S.NO Name of the drugs with Comments of the experts

composition
1. Mr. Jamil Anwar Director, As per information/ data provided by M/s.
Drugs Testing Laboratory, English Pharmaceutical industries Lahore for
Lahore registration of the product Terol (Tolterodine
HCl to Tolterodine 4mg) SR Capsule, the

standard Analytical Procedures for the finished
product has been studies. The stability data foe
accelerated stability program (6 Months) and
long term stability program (12 months) has
been performed for 1,3 and after 7 hours
dissolution profile. The study has been carried
out by M/s. Heterol, India.
The comparative study with the brand leader
i.e. M/s Pgizer’s product- Detrusitol 4mg SR
capsules, Bach No A..1566F, carried out by
M/s. English Pharmaceutical Industries, Lahore
with the comparable results at 01,1 and after 7
hours.
The Good Manufacturing Practices (GMP),
dated 22.08.2012 for M/s. Heterol, India is
attached with information/ data provided by
M/s. English Pharmaceuticals industries,
Lahore.
In the light of above and as per data/
information provided, the registration of
“Terol 4mg SR Capsule” is recommended
subject to the provision of Good
Manufacturing Practices of M/s English
Pharmaceutical, Lahore, and the firm may be
directed to submit the dissolution profile of
Terol 4mg SR Capsules before marketing.
Dr. Mehmood Ahmad, Granules with white to off white colour were
Islamia University seen in enclosed gelatin shells upon physical
Bahwalpur. examination. Dissolution studies were
conducted in USP type-1 basket with rotation
speed of 100 ± 4rpm at 37± 2°C. Standard
solution was made in mobile phase comprising
of buffer solution and acetonitrile. Stability
studies i.e real time at 30°± 75% RH for 2
years and accelerated at 40°C ± 75% RH for 06
month were conducted. During stability testing
various parameters were evaluated like
physical description, identification via HPLC
chromatogram, dissolution testing and assay.
Product passed all aforementioned parameters
and remained stable during the stability period.
Therefore, based on the presented results it is
recommended that the capsule Terol 4mg can
be registered.
3. Dr Zafar Iqbal Reply Awaited

Decision: Registration Board deliberated the reports and deferred the case for opinion
of Prof.Dr.Mehmood Ahmad regarding use of basket system for performing
dissolution studies instead of paddle system and to issue reminder to Dr.
Zafar Iqbal for furnishing expert opinion.
Case No.31: M/s Feroza International Lahore- Extension of contract manufacturing.
M/s Feroza International Lahore has informed that their below mentioned products were
approved in 212th meeting of registration board but letter was not issued. The firm has requested
to grant extension.
Sr Name of Drug
No.
1 Leetab Infusion 500mg
Levofloxacin…………………….500gm
2 Haemofer 200mg Injection
Each 5ml Contains:-
Iron as iron sucrose……………..200mg
3 Neuramin 500mcg injection
Each ml contains:-
Mecobalamine…………..500mcg
Following documents have been submitted.

 Fee of Rs: 50,000 per product.
 Form -5 with contract agreement with M/s English Pharma, Lahore.
 Copy of contract agreement between two parties.
 GMP certificate of M/s English Pharma, Lahore.
It is submitted that the above products of the firm were approved in 212 meeting and extension
was granted till 30.6.2010. However, the form did not apply for extension for the further period.
Now the firm has requested to grant approval for extension under new toll policy for the period
of five years.
Decision: Registration Board deferred for confirmation of composition of applied

products at S.No.02 and confirmatuion from record regarding non-issuance
of registration letters as claimed by the firm.

Pharmaceutical Evaluation Cell
Out of Queue Applications for New Molecule, Anticancer, HIV Aids and other life saving drugs.
Registration Board in 257th meeting decided to consider registration applications of

various classes of drugs on priority. Decision is as follows:
“Registration Board deliberated that drugs for treatment of chronic ailments and drugs which
are in short availability should have priority review process and consideration by the Board to
ensure their free availability. The Board decided that drugs for treatment of cancer, viral
diseases, thalaesemia, immunosuppresants, vaccine and sera, new molecules / formulations,
blood factors and bags will be given priority consideration.”
Registration Board considered (out of queue) following registration applications as

evaluated by Pharmaceutiacl Evaluation Cell. However the Board advised to inform DRAP’s
Policy Board regarding above mentioned decision.
List of human imported drugs Anticancer, Immunosuppressant, New molecules and Blood
bags applications with complete fee.
Muhammad Ansar Evaluator-I (PEC)
S/N Name and Brand Name Type of Remarks on Remark Decision

address of (Proprietary name + Form the s of the
manufacturer / Dosage Form + Initial formulation Evaluat
Applicant Strength) date, diary (if any) or.
Composition Fee including
Pharmacological including International
Group differential status in
Finished product fee stringent
Specification Demanded drug
Price / regulatory
Pack size agencies /
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
1. M/s. AJ Mirza Emeset 4mg/2ml Form -5-A MHRA.Ondan COPP Approved

Pharma (Pvt) Injection setron 2mg/ml valid as per
Ltd., Karachi. / Diary No. by M/s upto 13- Import
Each ml contains:- 136/ R&I Hameln 12-2013. Policy for
Manufactured Ondansetron Dated 15- GMP Finished
By Hydrochloride USP 06-2011 complian Drugs.
M/s Cipla Ltd Equivalent to Rs.15000 Local. Zofran t as per Firm will
D.P Pally Ondansetron…2mg & 350000 by M/s GSK. COPP. provide
(Narsapur Water for Injection dated 15- GMP valid
Road). Near BP……..q.s. 10-2012 dy valid legalized
Gandimaisamma No.951. upto 30- CoPP and
X Road, Anti emetic for As per 12-2016. Chairman
Hydarabad India chemotherapy induced PRC. Registratio
emesis. n Board
will permit
Manufacturer’s further
Specifications processing
of case.
36 months
2. M/s. AJ Mirza Emeset 4mg Tablets Form 5A MHRA.Ondan COPP Deferred
Pharma (Pvt) Dy.No 79 setron 4mg
issued on for the
Ltd., Karachi. Each film coated tablets 15-06-2011 tablet by M/s
12-06- submissio
Manufactured contains:- Rs.15000/ Accord 2008 by n of valid
by Ondansetron 15-10-2012 India. legalized
M/s. Cipla Ltd., Hydrochloride USP Rs.35000/- Local. Zofran GMP COPP, as
L-147 to L0147- Equivalent to 4mg by M/s complian it was
1, Verna Ondansetron……4mg As per PRC GSK. t as per expired at
Industrial Estate, COPP. time of
Verna Goa, Anti emetic for GMP 29- submissio
India. chemotherapy induced 06-2017. n of
emesis. registratio
n
applicatio
Manufacturer’s n.
Specifications
36 months
3. M/s. Merixil Capecitabine Form 5A MHRA. COPP Approved
Pharma Labosuan/Mericap Dy. No. Capecitabine issued by as per
Office No 28, 500mg Tablet 261 Dated 500mg f/c by Spain Import
2nd Floor, Rose 27-07-2011 M/s Accord. dated 12- Policy for
Plaza I-8 Each film coated tablet Rs. 15000/- 01-2016. Finished
Markaz, contains:- 09-12-2014 Local. Xeloda Brand Drugs
Islamabad. Capecitabine….500mg Rs. 85000/- 500mg by M/s Name for
Manufactured dy No. 225. Roche. Pakisatn
By adjuant treatment of Mericap
M/s. patients following Tablet.

Laboratorios surgery of stage III As per PRC GMP
Normon, S.A. colon cancer, meta- complian
Ronda De static colo-rectal t as per
Valdecarrizo, 6, cancer COPP.
Tres Cantos, GMP
28760, Madrid, issued
Spain. USP Specifications 13-06-
2014.
4. M/s. Merixil Temoeirgen 100mg Form 5A MHRA. COPP Approved
Pharma Capsules Temodal 5mg, issued on as per
Office No 28, Dy. No. 20mg, 100mg, 04-02- Import
2nd Floor, Rose Each capsule contains:- 721 dated 140mg, 180mg 2015 by Policy for
Plaza I-8 Temozolomide…100mg 18-08-2011 & 250mg by HPRA Finished
Markaz, Rs. 15000/- M/s Merck Ireland. Drugs
Islamabad. For newly diagnosed 08-12-2014 GMP
Product Glioblastoma Rs 85,000/- Local. complian
License Holder multiforme dy No. 226. Temoside t as per
M/s Fair-Med concomitantly with 20mg, 100mg COPP.
Healthcare radiotherapy. As per & 250mg by GMP
GmbH SRO M/s AJ. Mirza. issued
Planckstrasse Manufacturer’s dated 28-
13, 22765 Specifications 02-2014
Hamburg, by Irish
Germany. 24 Months Medicine
Manufactured Board.
by
M/s. Eirgen
Pharma Ltd.
64/65 Westside
Business Park
Old Kilmeaden
Road,
Waterford,
Ireland.
5. M/s. Oncogene Anaskebir 1mg Coated Form 5A MHRA. COPP Deferred

Pharmaceuticals Tablet Anastrozole issued on for the
, Karachi Dy No. 1mg f/c by 29-08- submissio
Each film coated tablet 1198 dated M/s consilent. 2012 and n of
Product License contains:- 28-11-2012 valid following:
Holder Anastrozole……1mg Rs.100,000 Local. upto 28- a. valid
M/s. /- Anastrozole 08-2013. legalized
Laboratorios Manufacturer’s 1mg by M/s GMP COPP, as
Aspen S.A. Specifications Rs.3300/Pa Pfizer complian already it
Remedios ck t as per was valid

3439/43, (Treatment of CoPP. upto 28-
C1407HJC, harmone recpotor Stability 08-2013.
Buenos Aires, positive advanced data as b. Stability
Argentina. breast cancer in post per data as per
Manufactured menopausal women) condition conditions
by s of Zone of Zone
M/s IV-A not IV-A.
Laboratorios attached. Druds
Eczane Pharma DSL is c. Sales
S.A. Laprida 43 not License.
Localidad attached. d.
Avellaneda. Clarificat Clarificati
Prov. Bs. As ion on
Craveri S.A.I.C- regardin regarding
Arengreen 830, g the the
CABA Blipack place of manufactu
S.A-Av. Juan B. manufact ring site as
Justo 7669, ure. it is
Caba. different
in
Form5A
and CoPP.
6. M/s. Oncogene Kebirzol 2.5mg Coated Form 5A MHRA. Femra The Deferred
Pharmaceuticals Tablets 2.5mg f/c product for the
, Karachi Dy No. tablet by M/s is not submissio
Each tablet contains:- 1197 dated Novartis. actually n /
Product License Letrozole……2.5mg 28-11-2012 in the clarificatio
Holder Rs.100,000 Local. Femra market n of
M/s. (Adjuant treatment of /- 2.5mg by M/s of following
Laboratorios post-menopausal Novartis. country a. The
Aspen S.A. women with harmone Rs.5000/pa of origin product is
Remedios recpotor positive ck as not
3439/43, invasive early breast mentione actually in
C1407HJC, cancer). d in the market
Buenos Aires, COPP. of country
Argentina. USP Specifications DSL is of origin
Manufactured not as
by attached. mentioned
M/s GMP in COPP.
Laboratorios certificat b. Drug
Eczane Pharma e is not Sales
S.A. Laprida 43 attached. License.
Localidad Complet c.
Avellaneda. e Complete
Prov. Bs. As descripti descriptio
Craveri S.A.I.C- on of the n of the

Arengreen 830, tablet is tablet.
CABA Blipack not d.
S.A-Av. Juan B. provided Clarificati
Justo N 7.669, as film on is
CABA. coated. required
Clarificat for
ion is manufactu
required rer and
for market
manufact authorizati
urer and on holder.
market e. Stability
authoriza data as per
tion conditions
holder. of Zone
Stability IV-A.
data as f.
per Clarificati
condition on
s of Zone regarding
IV-A not the
attached. manufactu
Clarificat ring site as
ion it is
regardin different
g the in
place of Form5A
manufact and CoPP
ure.
7. M/s. Amgomed, Farmatide 50mg Tablets Form 5A MHRA. Photocop Deferred
Office # 5, 1st Bicalutamide y of for the
Floor Rose 1, Each film coated Dy No.510 50mg f/c by legalized submissio
Plaza I-8 tablets contains:- dated M/s Sun COPP n of valid
Markaz, Bicalutamide 09-06-2014 pharma. issued legalized
Islamabad. ………….50mg Rs.100,000 dated 30- COPP.
/- Local. 01-2014
Manufactured Adjuant to radial Calutide 50mg (Photoco
by prostectomy or radio- As per by M/s AJ. py)
M/s. West therapy in patients with SRO Mirza. GMP
Pharma, locally advanced complian
Producoes de prostate cancer t as per
Especialiaes COPP.
Farmaceuticas, (Photoco
SA Rua Joao de USP Specifications py)
Deus, n. 11,
Amadora, 2700- 03 years

486, Portugal.
8. M/s. Lundbeck Brintellix 10mg Tablets Form 5-A MHRA. Orignal Approved
Pakistan (Pvt) Brintellix 5, legalized as per
Ltd., 40 T/4, Each film coated tablet Dy No.569 10 & 20mg f/c COPP Import
Blessing Street, contains:- 30-06-2014 tablet by M/s issued by Policy for
Block 6, Vortioxetine Rs.50,000/- Lundbeck. EMA on Finished
P.E.C.H.S, hydrobromide …10mg dated 04- Drugs
Karacki. Market equivalent to 10mg Rs.265/tabl 02-2014
Authorization Vortioxetine et GMP
Holder. complian
M/s. H. (Receptor Antagonist). t as per
Lundbeck A/S, New Molecule CoPP.
Ottiliavej 9,
2500 Valby, Manufacturer’s
Denmark. Specifications
Manufacturer
also responsible 30 months
for batch release
QC, Primary &
Secondary
Packaging.
M/s. H.
Lundbeck A/S,
Ottiliavej 9,
2500 Valby,
Denmark.
Site Responsible
for Quality
Control
M/s Eurofins
Pharma A/S,
Ornebjergvej 1,
2600 Glostrup,
Denmark.
Site for Primary
& Secondary
Packaging.
M/s Elaiapharm,
2881, route des
Cretes, Z.I. Les
Bouillides,
Sophia
Antipolis,
06560, France.
9. M/s. Lundbeck Brintellix 20mg Tablets Form 5-A MHRA. Orignal Approved

Pakistan (Pvt) Brintellix 5, legalized as per
Ltd., 40 T/4, Each film coated tablet Dy No.570 10 & 20mg f/c COPP Import
Blessing Street, contains:- 30-06-2014 tablet by M/s issued by Policy for
Block 6, Vortioxetine Rs.50,000/- Lundbeck. EMA on Finished
P.E.C.H.S, hydrobromide …20mg dated 03- Drugs
Karacki. equivalent to 20mg Rs.398/tabl 02-2014
Vortioxetine et. GMP
Authorization complian
Holder. (Receptor Antagonist). t as per
M/s. H. New Molecule CoPP.
Lundbeck A/S,
Ottiliavej 9, Manufacturer’s
2500 Valby, Specifications
Denmark.
Manufacturer 30 months
also responsible
for batch release
QC, Primary &
Secondary
Packaging.
M/s. H.
Lundbeck A/S,
Ottiliavej 9,
2500 Valby,
Denmark.
Site Responsible
for Quality
Control
M/s Eurofins
Pharma A/S,
Ornebjergvej 1,
2600 Glostrup,
Denmark.
Site for Primary
& Secondary
Packaging.
M/s Elaiapharm,
2881, route des
Cretes, Z.I. Les
Bouillides,
Sophia
Antipolis,
06560, France.
10. M/s. CCL Praxed Injection 100mg Form 5A MHRA. Dossier Deferred
Pharmaceuticals Alimta 100mg is a for the
(Pvt) Ltd., 65- Each vial contains:- Dy No.Nil & 500mg photocop submissio

Industrial Estate, Pemetrexed (as dated 30- powder for y. n of
Kot Lakhpat, disodium)………..100 06-2014 conc. For Fee following.
Lahore mg Rs.50,000/- infusion by Rs.50,00 a.
M/s Eli Lilly. 0 is a Verificatio
M/s. Glenmark (Malignant pleural As per photocop n of Fee
Generics S.A. mesothelioma non- Brand Local. Alimta y. Rs.50,000
Calle 9 Ing. small cell lung cancer) leader 100mg & Different as it is a
Meyer Oks No 500mg by M/s ial fee photocopy
593 Pilar Manufacturer’s Eli Lilly. not .
(B1629 MAX), Specifications provided. b.
Buenos Aires, Photocop Differentia
Argentina. y of l fee as
03 years COPP molecule
issued is me too.
dated 06- c. Valid
12-2013. legalized
(valid for COPP
12 d. Stability
months) data as per
Brand conditions
Name of Zone
Proxed. IV A.
GMP
complian
t as per
CoPP.
Stability
data for
one
batch is
attached.
11. M/s. CCL Praxed Injection 500mg Form 5A MHRA. Dossier Deferred
Pharmaceuticals Alimta 100mg is a for the
(Pvt) Ltd., 65- Each vial contains:- Dy No.Nil & 500mg photocop submissio
Industrial Estate, Pemetrexed (as dated 30- powder for y. n of
Kot Lakhpat, disodium)………..500 06-2014 conc. For Fee following.
Lahore mg Rs.50,000/- infusion by Rs.50,00 a.Verificat
M/s Eli Lilly. 0 is a ion of Fee
M/s. Glenmark (Malignant pleural As per photocop Rs.50,000
Generics S.A. mesothelioma non- Brand Local. Alimta y. as it is a
Calle 9 Ing. small cell lung cancer) leader 100mg & Different photocopy
Meyer Oks No 500mg by M/s ial fee .
593 Pilar Manufacturer’s Eli Lilly. not b.Different
(B1629 MAX), Specifications provided. ial fee as
Buenos Aires, Photocop molecule
Argentina. y of is me too.

03 years COPP c. Valid
issued legalized
dated 06- COPP
12-2013. d. Stability
(valid for data as per
12 conditions
months) of Zone
Brand IV A.
Name
Proxed.
GMP
complian
t as per
CoPP.
Stability
data for
one
batch is
attached.
12. M/s. Revive Pemex Injection 500mg Form 5A MHRA. COPP Approved
Health Care, Alimta 100mg valid as per
Office 503, 5th Each vial contains:- Dy no 24 & 500mg upto 10- Import
Floor, 6 Main Pemetrexed (As dated 04- powder for 05-2017. Policy for
Gulberg, Jail Pemetrexed 07-2014 conc. For GMP Finished
Road, Lahore. Disodium)…….500mg Rs.100,000 infusion by complian Drugs
Excipients…….q.s /- M/s Eli Lilly. t as per
Manufactured COPP.
By (Malignant pleural As per Local. Alimta
M/s. United mesothelioma non- SRO. 100mg & Free
Biotech (P) Ltd., small cell lung cancer) 500mg by M/s sales
Village Eli Lilly. certificat
Bagbania, Manufacturer’s e issued
Baddi-Nalagarh Specifications dated 26-
Road, District- 02-2016.
Solan (H.P) 24 months
174101, India. GMP
valid
upto 17-
09-2017.
13. M/s. Revive Cagin 50mg Injection Form 5A MHRA. Free Deferred
Health Care, Cancidas 50 sales as Anti-
Office 503, 5th Each vial contains:- Dy No.26 powder for certificat fungal
Floor, 6 Main Caspofungin Acetate dated 04- conc. For e issued drugs are
Gulberg, Jail eq. to 07-2014 infusion by dated 26- not
Road, Lahore. Caspofungin…….50mg Rs.50,000/- M/s MSD. 02-2016. importable

COPP from India
M/s. United (Antifungal/Supportive As per PRC valid as per
Biotech (P) Ltd., cancer therapy) upto 10- Import
Village New Molecule 5-2017. Policy
Bagbania, GMP Order,
Baddi-Nalagarh Manufacturer’s valid 2016.
Road, District- Specifications. upto 17-
Solan (H.P) 09-2017.
174101, India. 24 months
14. M/s. Revive Doxulip 20mg Injection Form 5A MHRA. COPP Approved
Health Care, Caelyx valid as per
Office 503, 5th Each ml contains:- Dy. No. 27 2mg/ml upto10- Import
Floor, 6 Main Doxorubicin dated 04- (10ml) by M/s 05-2017. Policy for
Gulberg, Jail Hydrochloride 07-2014 Janssen. Finished
Road, Lahore. USP..2mg Rs.100,000 GMP Drugs
(As pegylated /- Local. complian
Manufactured Liposomal) Doxopeg t as per
by As per 20mg/10ml by COPP.
M/s. United Alone for meta-static PRC. M/s Free
Biotech (P) Ltd., breast cancer, Ferozsons. sales
Village advanced ovarian certificat
Bagbania, cancer. In e issued
Baddi-Nalagarh combination with dated 26-
Road, District- Bortezomide for 02-2016.
Solan (H.P) treatment of
174101, India. progressive multiple GMP
myeloma. valid
upto 17-
Manufacturer’s 09-2017.
Specifications
24 months
15. M/s. Revive Temotec 100mg Form 5A
MHRA. COPP Approved
Health Care, Capsules Temodal 5mg, valid as per
Office 503, 5th Dy. No 28 20mg, 100mg, upto 10- Import
Floor, 6 Main Each capsules contains:-dated 04- 140mg, 180mg 05-2017. Policy for
Gulberg, Jail Temozolomide 07-2014 & 250mg by Finished
Road, Lahore. USP…………..100mg Rs.100,000 M/s Merck GMP Drugs
/- complian
Manufactured For newly diagnosed Local. t as per
by Glioblastoma As per Temoside COPP.
M/s. United multiforme SRO 20mg, 100mg
Biotech (P) Ltd., concomitantly with & 250mg by Free
Village radiotherapy M/s AJ. Mirza. sales
Bagbania, issued
Baddi-Nalagarh Manufacturer’s dated 26-

Road, District- Specifications 12-2015.
Solan (H.P)
174101, India. 24 months GMP
valid
upto 17-
09-2017.
16. M/s. Revive Ambilip 50mg Injection Form 5A MHRA. COPPDefered as

Health Care, Ambisome valid
the
Office 503, 5th Each vial contains:- Dy No.29 50mg Powder upto 10-
product
Floor, 6 Main Liposomal dated 04- for Infusion by 05-2017.
does not
Gulberg, Jail Amphotericin B 07-2014 M/s Gilead. fall in the
Road, Lahore. USP………50mg Rs.100,000 GMP priority
/- Local. complian list.
M/s. United Antifungal Anfogen t as per Moreover
Biotech (P) Ltd., As per 50mg, COPP. Anti-
Village Manufacturer’s SRO. Ferozsons fungal
Bagbania, Specifications Free drugs are
Baddi-Nalagarh sales not
Road, District- 24 months issued importable
Solan (H.P) dated 26- from India
174101, India. 02-2016. as per
Import
GMP Policy
valid Order,
upto 17- 2016
09-2017.
17. M/s. Revive Oncotar 100mg Form 5A MHRA. COPP Approved
Health Care, Injection Cytarabine valid as per
Office 503, 5th Dy. No 30 100mg/ml by upto 10- Import
Floor, 6 Main Each ml contains:- dated 04- M/s Pfizer. 05-2017. Policy for
Gulberg, Jail Cytarabine injection 07-2014 Finished
Road, Lahore. BP………100mg Rs.100,000 Local. GMP Drugs
Water for injection s /- Cytarine complian
Manufactured IP………….q.s. 100mg, 500mg t as per
by As per PRC & 1gm by M/s COPP.
M/s. United Acute myeloid Atco.
Biotech (P) Ltd., leukaemia and for FSC
Village other acute leukaemias issued
Bagbania, for children and adults dated 26-
Baddi-Nalagarh 02-2016.
Road, District- USP Specifications
Solan (H.P) GMP
174101, India. 24 months valid
upto 17-
09-2017.

18. M/s. Revive Unicristin 1mg injection Form 5A MHRA. COPP Approved
Health Care, Vincristine valid as per
Office 503, 5th Each ml contains:- Dy. No 25 Sulphate upto 10- Import
Floor, 6 Main Vincristine Sulphate dated 04- 1mg/ml by 05-2017. Policy for
Gulberg, Jail USP…..1mg 07-2014 M/s Hospira. GMP Finished
Road, Lahore. Rs.100,000 complian Drugs
Indicated for /- Local. Vinfate t as per
Manufactured leukemias, malignant by M/s Aster. COPP.
by lymphomas, multiple As per FSC
M/s. United myeloma, solid tumors SRO issued
Biotech (P) Ltd., dated 26-
Village USP Specifications 02-2016.
Bagbania, GMP
Baddi-Nalagarh 24 months valid
Road, District- upto 17-
Solan (H.P) 09-2017
174101, India.
19. M/s. Novartis Afinitor 2mg Form 5A FDA. Afinitor Dossier Deferred
Pharma Dispersible Tablets 2mg, 3mg & is for the
(Pakistan) Dy No. Nil 5mg Disperz photocop verificatio
Limited, 15 Each dispersible tablet dated 16- Tablets by M/s y fee Rs. n of fee
West Wharf, contains:- 07-2014 Novartis. 50,000 is and
Karachi. Everolimus…………… Rs.50,000/- photocop submissio
…2mg y. n of valid
Manufactured Rs. Photocop legalized
by. (for harmone receptor 126,000/30 y of CoPP.
M/s. Novartis positive advaced breast ’s. COPP
Pharma Stein cancer, neuro-endocrine provided.
AG, Stein, tumors of pancreatic GMP
Switzerland. origion, gastro-intestinal attached.
or lung origin renal cell
carcinoma)
30 months
20. M/s. Novartis Afinitor 3mg Form 5A FDA. Afinitor Deferred
Pharma Dispersible Tablets 2mg, 3mg & Dossier for the
(Pakistan) Each dispersible tablet Dy No. 88 5mg Disperz is verificatio
Limited, 15 contains:- dated 16- Tablets by M/s photocop n of fee
West Wharf, Everolimus…………… 07-2014 Novartis. y fee Rs. and
Karachi. …3mg Rs.50,000/- 50,000 is submissio
photocop n of valid
Manufactured (for harmone receptor Rs.189000/ y. legalized
by. positive advaced breast 30’s Photocop CoPP.
M/s. Novartis cancer, neuro-endocrine y of

Pharma Stein tumors of pancreatic COPP
AG, Stein, origion, gastro-intestinal provided.
Switzerland. or lung origin renal cell GMP
carcinoma) attached.
Manufacturer’s
Specifications
30 months
21. M/s. Novartis Afinitor 5mg Form 5A FDA. Afinitor Dossier Deferred
Pharma Dispersible Tablets 2mg, 3mg & is for the
(Pakistan) Dy No. 87 5mg Disperz photocop verificatio
Limited, 15 Each dispersible tablet dated 16- Tablets by M/s y fee Rs. n of fee
West Wharf, contains:- 07-2014 Novartis. 50,000 is and
Karachi. Everolimus…………… Rs.50,000/- photocop submissio
…5mg y. n of valid
Manufactured Rs.315000/ Photocop legalized
by. (for harmone receptor 30’s y of CoPP.
M/s. Novartis positive advaced breast COPP
Pharma Stein cancer, neuro-endocrine provided.
AG, Stein, tumors of pancreatic GMP
Switzerland. origion, gastro-intestinal attached.
or lung origin renal cell
carcinoma)
Manufacturer’s
Specifications
30 months
22. M/s. Macter Gefwin 250mg Tablets Form 5A MHRA. Iressa COPP Deferred
International Dy. No 250mg f/c not for the
Limited, F-216, Each Film Coated 3121 Dated tablet by M/s provided submissio
SITE, Karachi. Tablets contains:- 07-08-2014 AstraZeneca. n of
Manufactured Gefitinib………..250m Rs.50,000/- GMP not following:
by g attached. a. valid
M/s. Atlanta Excipients………qs Rs.As per Stability legalized
Biological (Pvt) PRC data as COPP
Ltd.,Village- (Advanced or meta- per b. Stability
Kotla, static non small cell condition data as per
Barotiwala, lung cancer) s of Zone conditions
Baddi, Distt. IV-A not of Zone
Solan, (H.P) attached. IV-A.
India. Finished c. Finished
product product
specifica specificati
tions are ons.

not d. Sole
provided. Agency
Sole agreement.
Agency
agreeme
nt is not
attached
23. M/s. Macter Cytonib Tablet 100mg Form 5A MHRA. COPP Deferred
International Dy. No 872 Glivec 100mg valid for the
Limited,F-216, Each tablets contains:- Dated & 400mg f/c upto 22- clarificatio
SITE, Imatinib 29-08-2014 by M/s 08-2014 n of
Karachi. / Mesylate………100mg Rs.50,000/- Novartis. but the following:
Marketing addresse a. COPP
Authorization: (Philadelphia Local. Glivec s of as the
M/s. Atlanta chromosome positive 100mg & Market addresses
Biological (Pvt) chronic myeloid 400mg by M/s authoriza of Market
Ltd.,Poddar leukemia) Novartis tion authorizati
Court 9th Floor, Pharma. holder on holder
Gate No.1, 18 Manufacturer’s and and
Rabindra Sarani, Specifications manufact manufactu
Kolkata-700001, 02 years urer are rer are not
India. not as as per
Manufacturing per COPP.
facility: COPP.
M/s. Ladley b. Stability
Formulations GMP not data as per
Village Kotla, provided. Zone IV-
Barotiwala, Stability A.
Distt. Solan data as
(H.P), India. per Zone
IV-A not
provided.
24. M/s. Macter Bortemore 3.5mg Form 5A MHRA. COPP Deferred

International Injection Dy. No 873 Velcade 3.5mg valid up for the
Limited,F-216, dated 29- (as mannitol to 22-08- submissio
SITE, Each vial contains:- 08-2014 boronic ester) 2014 but n /
Karachi. / Bortezomib…………3. Rs.50,000/- Powder for the clarificatio
Marketing 5mg solution for addresse n of the
Authorization: As per injection. s of following
M/s. Atlanta (Lumphocutic PRC. Market a.
Biological (Pvt) leukemia, indolent authoriza addresses
Ltd., Poddar non-Hodgkin’s tion of market
th
Court 9 Floor, lymphoma, multiple holder authorizati
Gate No.1, 18 myeloma). and on holder
Rabindra Sarani, manufact and

Kolkata-700001, 02 years urer are manufactu
India. not as rer are not
Manufacturing per as per
facility: COPP. COPP.
M/s. Ladley Stability b.Stability
Formulations data not data as per
Village Kotla, attached. conditions
Barotiwala, Finished of Zone
Distt. Solan product IV A.
(H.P), India. specifica c.Finished
tions are product
not specificati
provided. ons.
Internati d.
onaly the Internation
product aly the
is present product is
as present as
mannitol mannitol
boronic boronic
ester. ester.
Clarificat e.whether
ion the
whether product is
the in liquid
product form or
is in powder
liquid form.
form or
powder
form.
25. M/s. Requip PD 2mg Form 5A MHRA.. COPP Approved

GlaxoSmithKlin Tablets Aimpart Excel issued as per
e Pakistan Dy No. 2mg, 4mg and dated10- Import
Limited, 35- Each prolonged release 6581 R&I 8mg 07-2014 Policy for
Dockyard Road, tablets contains:- dated 8- prolonged vide No. Finished
West Wharf, Ropinirole 09-2014 release tablets 014/1680 Drugs
Karachi-74000. hydrochloride Rs.50,000/- by M/s by Spain.
equivalent to 2mg Zantiva GMP
Market ropinirole free base Will be complian
Authorization submitted t as per
Holder (Non-ergoline D2/D3 later COPP.
M/s. dopamine agonist)

Glaxosmithkline New formuation
, S.A. Severo
Ochoa, 2 28760- 18 months
Tres Cantos
(Madrid) Spain.
Manufactured
by
M/s Glaxo
Wellcome, S.A.
Avda. De
Extremadura, n
3 09400-Aranda
De Duero
(Burgos) Spain.
26. M/s. Requip PD 4mg Form 5A MHRA.. COPP Approved

GlaxoSmithKlin Tablets Aimpart Excel issued as per
e Pakistan Dy No.656 2mg, 4mg and dated10- Import
Limited, 35- Each prolonged release R&I dated 8mg 07-2014 Policy for
Dockyard Road, tablets contains:- 08-09-2014 prolonged vide No. Finished
West Wharf, Ropinirole Rs.50,000/- release tablets 014/1678 Drugs
Karachi-74000. hydrochloride by M/s by Spain.
equivalent to 4mg Will be Zantiva GMP
Market ropinirole free base submitted complian
Authorization later t as per
Holder (Non-ergoline D2/D3 COPP.
Glaxosmithkline New formuation
, S.A. Severo
Ochoa, 2 28760- (24 months)
Tres Cantos
(Madrid) Spain.
Manufactured
by
M/s Glaxo
Wellcome, S.A.
Avda. De
Extremadura, n
3 09400-Aranda
De Duero
(Burgos) Spain.
27. M/s. Requip PD 8mg 08-09-2014 MHRA COPP Approved

GlaxoSmithKlin Tablets Rs.50,000/- Aimpart Excel issued as per
e Pakistan 2mg, 4mg and dated10- Import
Limited, 35- Each prolonged release 8mg 07-2014 Policy for

Dockyard Road, tablets contains:- prolonged vide No. Finished
West Wharf, Ropinirole release tablets 014/1679 Drugs
Karachi-74000. hydrochloride by M/s by Spain.
equivalent to 8mg Zantiva GMP
Market ropinirole free base complian
Authorization t as per
Holder (Non-ergoline D2/D3 COPP.
Glaxosmithkline New formulation
, S.A. Severo
Ochoa, 2 28760-
Tres Cantos (24 months)
(Madrid) Spain.
Manufactured
by
M/s Glaxo
Wellcome, S.A.
Avda. De
Extremadura, n
3 09400-Aranda
De Duero
(Burgos) Spain.
28. M/s. Bayer Visanne (Dienogest) Form 5A Germany. COPP Approved

Pakistan 2mg Tablets Visanne issued as per
(Private) Dated 10- (Dienogest) dated 11- Import
Limited, C-21, Each tablet contains:- 09-2014 2mg Tablets 06-2014. Policy for
S.I.T.E., Karachi Dienogest………….2m vide diary GMP Finished
g No. 667 issued Drugs
Product license Rs.50,000/- dated 26-
holder: (Steroid Hormones) 04-2013.
M/s. Jenapharm New Molecule Not Approval
GmbH & Co. mentioned status
KG, Otto- Manufacturer’s require
Schott-Strasse Specifications to be
15 D-07745 provided.
Jena Germany 36 months Now the
Bulk firm has
Manufacturer, requeste
Packaging and d for the
final release: finished
M/s. Bayer import
Weimar GmbH from
& Co. KG Germany
DÖbereinerstras .
se 20 99427

Weimar,
Germany.
29. M/s. PharmEvo Bicatero 50mg Tablets Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Bicalutamide valid for the
Plot No. A-29, Each film coated tablets Dy. No 673 50mg f/c by upto 19- submissio
North West contains:- Dated 11- M/s Sun 09-2014. n of
Industrial Zone, Bicalutamide 09-2014 pharma. GMP Stability
Port Qasim, USP……….50mg Rs.100,000 complian data as per
Karachi /- Local. t as per conditions
(Adjuant to radial Calutide 50mg COPP. of Zone
Manufactured prostectomy or radio- As per PRC by M/s AJ. IV-A &
By. therapy in patients with Mirza. Photocop valid
M/s. Hetero locally advanced y of legalized
Labs Limited prostate cancer) GMP COPP.
Unit – VI Sy valid
No. 410 & 411, USP Specifications upto 19-
APIIC 09-2014.
Formulation 02 years
SEZ, Polepally Stability
Village, data is
Jadcherla not as
Mandal, per
Mahaboob condition
Nagar (Dist) s of Zone
509301, Andhra IV-A.
Pradesh, India.
30. M/s. PharmEvo Bentero 100mg Form 5 A FDA. COPP Deferred

(Pvt) Ltd., Injection Bendamustine valid for the
Plot No. A-29, Dy. No 676 powder for upto 30- submissio
North West Each vial contains:- dated 11- infusion by 12-2015. n of
Industrial Zone, Bendamustin 09-2014 M/s Hospira. a.Stability
Port Qasim, Hydrochloride………… Rs.100,000 Photocop data as per
Karachi 100mg /- y of conditions
Water for GMP 19- of Zone
Manufactured injections……….Ph.Eu As per 09-2014. IV-A.
By. r….q.s. SRO b.valid
M/s. Hetero Stability legalized
Labs Limited (Lumphocutic data is COPP.
Unit – VI Sy leukemia, indolent not as c.Separate
No. 410 & 411, non-Hodgkin’s per applicatio
APIIC lymphoma, multiple condition n for the
Formulation myeloma) s of Zone registratio
SEZ, Polepally IV-A. n
Village, Manufacturer’s applicatio

Jadcherla Specifications Firm has n for WFI.
Mandal, not
Mahaboob 02 years applied
Nagar (Dist) for
509301, Andhra separate
Pradesh, India. registrati
on of
water for
injection.
31. M/s. PharmEvo Bortero 3.5mg Injection Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Velcade 3.5mg valid for the
Plot No. A-29, Each vial contains:- Dy. No 673 (as mannitol upto 30- submissio
North West Bortezomib…….3.5mg dated 11- boronic ester) 12-2015 n of
Industrial Zone, Water for Injection 09-2014 Powder for a.Stability
Port Qasim, Ph.Eur….q.s Rs.100,000 solution for Photocop data as per
Karachi / injection. y of conditions
(Lumphocutic GMP of Zone
Manufactured leukemia, indolent As per valid IV-A.
By. non-Hodgkin’s SRO. upto 19- b.valid
M/s. Hetero lymphoma, multiple 09-2014. legalized
Labs Limited myeloma) COPP.
Unit – VI Sy Stability c.Separate
No. 410 & 411, Manufacturer’s data not applicatio
APIIC Specifications provided. n for the
Formulation registratio
SEZ, Polepally 02 years Internati n
Village, onaly the applicatio
Jadcherla product n for WFI.
Mandal, is present
Mahaboob as
Nagar (Dist) mannitol
509301, Andhra boronic
Pradesh, India. ester.
Firm has
not
applied
for
separate
registrati
on of
water for
injection.
32. M/s. PharmEvo Capetero 500mg Tablets Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Capecitabine valid for the

Plot No. A-29, Each film coated tablets Dy. No 678 500mg f/c by upto 19- submissio
North West contains:- dated 11- M/s Accord. 09-2014. n of
Industrial Zone, Capecitabine 09-2014 a.Stability
Port Qasim, USP………500mg Rs.100,000 Local. Xeloda Photocop data as per
Karachi. (adjuant treatment of /- 500mg by M/s y GMP conditions
patients following Roche. valid of Zone
Manufactured surgery of stage III As per upto 19- IV-A.
By. colon cancer, meta- SRO. 09-2014. b.valid
M/s. Hetero static colo-rectal legalized
Labs Limited cancer) Stability COPP.
Unit – VI Sy is not as c.Separate
No. 410 & 411, USP Specifications per applicatio
APIIC condition n for the
Formulation 02 years s of Zone registratio
SEZ, Polepally IV A. n
Village, applicatio
Jadcherla n for WFI.
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
33. M/s. PharmEvo Capetero 150mg Tablets Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Capecitabine valid for the
Plot No. A-29, Each film coated tablets dy. NO 675 Accord 150mg upto 19- submissio
North West contains:- dated 11- f/c by M/s 09-2014. n of
Industrial Zone, Capecitabine 09-2014 Accord. Stability
Port Qasim, USP………150mg Rs.100,000 Photocop data as per
Karachi /- y GMP conditions
(adjuant treatment of valid of Zone
Manufactured patients following As per upto 19- IV-A &
By. surgery of stage III SRO 09-2014. valid
M/s. Hetero colon cancer, meta- legalized
Labs Limited static colo-rectal Stability COPP.
Unit – VI Sy cancer) is not as
No. 410 & 411, per
APIIC USP Specifications condition
Formulation s of Zone
SEZ, Polepally 02 years IV A.
Village,
Jadcherla
Mandal,
Mahaboob
Nagar (Dist)

509301, Andhra
Pradesh, India.
34. M/s Anoro Ellipta Form-5AMHRA. Ano Already Approved
GlaxoSmithKlin Dry Powder Inhaler Ellipta by M/s approved as per
e PakistanEach pre-dispensedDy. No: GSK in 254th Import
Limited 35-dose contains. 693 dated meeting Policy for
Dockyard Road, Umeclidinium…….62.5 18-09-2014 but later Finished
West Wharf,mcg 50,000/- on Drugs
Karachi. Vilanterol (asdated 18- deleted
trifenatate)…25mcg 09-2014 in 256th
(Long acting muscarinic meeting
M/s Glaxo antagonist (LAMA), MRP will as the
Operations UK and a long-acting beta-2 be decision
Limited, Ware agonist (LABA) submitted on new
UK New Molecule later molecule
s was not
clear.
COPP
issued on
06-08-
2014.
35. M/s. Novartis Sandostatin 0.2mg/ml Form 5A MHRA. COPP Approved
Pharma Multi-dose Vial Dy. No 701 Sandostatin issued by as per
(Pakistan) dated 22- 1000mcg/5ml Swiss Import
Limited, 15 Each 5ml vial contains:- 09-2014 by M/s medica Policy for
West Wharf, Octreotide……………. Rs.50,000/- Novartis. Switzerla Finished
Karachi. 1mg nd on Drugs
Rs.9400/5 21-03-
Product Acromegaly/Carcinoid ml vial 2014.
License Holder. Tumors / Vasoactive GMP 07-
M/s. Novartis Intestinal tumors 04-2014.
Pharma Schweiz
AG, 6343,
Risch,
Switzerland. Manufacturer’s
Manufactured Specifications
By
M/s Novartis 48 months
Pharma Stein
AG
Schaffhauserstr
asse 4332 Stein,
Switzerland
36. M/s. Novartis Sandostatin 0.5mg/ml Form 5A MHRA. COPP Approved
Pharma Ampoule Dy. NO Sandostatin issued on as per
(Pakistan) 700 Dated 500mcg/1ml 21-03- Import

Limited, 15 Each 1ml ampoule 22-09-2014 by M/s 2014 by Policy for
West Wharf, contains:- Rs.50,000/- Novartis. Switzerla Finished
Karachi. Octreotide……………. nd. Drugs
0.5mg Rs.23,000/ GMP 07-
Product 5 04-2014
License Holder. Acromegaly/Carcinoid ampoules.
M/s. Novartis Tumors / Vasoactive
Pharma Schweiz Intestinal tumors
AG, 6343, Risch
, Switzerland. Manufacturer’s
Manufactured Specifications
By 36 months
M/s Novartis
Pharma Stein
AG
Schaffhauserstr
asse 4332 Stein,
Switzerland
37. M/s. Kivexa Tablets Form 5A
MHRA. COPP Approved
GlaxoSmithKlin Each film coated tablets Kivexa by M/s issued as per
e Pakistan contains:- Dy No. 729 ViiV dated 16- Import
Limited, 35- Abacavir 600mg (as R&I dated 05-2014 Policy for
Dockyard Road, abacavir sulfate) and 30-09-2014 vide no. Finished
West Wharf, Lamivudine………..300 Rs.50,000/- 10/14/76 Drugs
Karachi. mg 509 by
Will be EMA.
Market (HIV Indicated for the submitted GMP
Authorization management of HIV later. complian
Holder infection) t as per
M/s ViiV New formulation & COPP.
Healthcare UK Anti HIV
Limited, 980
Great West 36 months
Road, Brentford,
Middlesex, TW8
9GS, United
Kingdom
Manufactured
by M/s. M/s
GlaxoSmithKlin
e
Pharmaceuticals
SA, ul.
Grunwaldzka
189, 60-322

Poznan, Poland.
Site Responsible
for Primary &
Secondary
Packaging
M/s Glaxo
Wellcome S.A.,
Avenida
Extremadura 3,
Aranda de
Duero, Burgos,
09400, Spain.
38. M/s. Tivicay Tablets Form 5-A MHRA. Legalize Approved
GlaxoSmithKlin Dy.No.45 Tivicay by d COPP as per
e Pakistan Each film coated tablet R&I Dated M/s ViiV was Import
Limited, 35- contains:- 16-10-2014 issued by Policy for
Dockyard Road, Dolutegravir (as Rs.50,000/- EMA Finished
West Wharf, Dolutegravir dated. Drugs
Karachi. Sodium)……50mg Price will 19.08-
be provided 2014
Market (HIV. Indicated for the later
Authorization management of HIV
Holder infection)
M/s ViiV New Molecule
Healthcare UK
Limited, 980 24 months
Great West
Road, Brentford,
Middlesex, TW8
9GS, United
Kingdom
Manufactured
by M/s. Glaxo
Operations UK
Ltd, Priory
Street, Ware,
Hertfordshire
SG12 ODJ,
United
Kingdom.
Site Responsible
for Primary &
Secondary
Packaging
M/s Glaxo

Wellcome S.A.,
Avenida
Extremadura 3,
Aranda de
Duero, Burgos,
09400, Spain.
39. M/s. RG Pyramax 180mg/60mg Form 5A WHO Free Approved
Pharmaceutica Each film coated tablets approved sales as per
(Pvt) Ltd., contains:- Dy No. 84 formulation certificat Import
Progressive Artesunate…………60 dated 10- for treatmente issued Policy for
Square, Block 6, mg 11-2014 of malaria dated 17- Finished
Shahra-e-Faisal, Pyronaridine Rs.50,000/- 08-2011 Drugs
Karachi-75400./ tetraphosphate………18 vide No.
M/s. Shin Poong 0mg Rs. 2014-
Pharmaceutical (Pyronaridine in142/tablet A1-0403.
Co. Ltd., 70, combination with GMP
Sandan-ro artesunate, an certificat
19beon-gil, artemisinin derivative). e issued
Danwon-gu New Molecule / dated 17-
Ansan-si formualtion 07-2013
Gyeonggido, 02 years vide No.
Korea. 2013-
D1-2253.
40. M/s. Premier Gemtero 1.0g Injection Form 5A MHRA. COPP/Fr Deferred
Agencies, Gemcitabine ee sales for the
60-Muslimabad, Each vial contains:- DY. No 71 1g Powder for certificat submissio
Jamshed Gemcitabine dated 13- injection by e not n of valid
Quarters M.A. Hydrochloride 11-2014 M/s Ranbaxy attached. legalized
Jinnah Road equivalent to Rs.100,000 GMP COPP and
Extension, Gemcitabine 1.0g for / certificat Stability
Karachi.-74800 injection e is not data as per
As per attached. conditions
Manufactured (Advanced or met- SRO Stability of Zone
by static bladder cancer data is IV-A.
M/s. Hetero in combination with not as
Labs Limited , cisplatin, locally or per
Unit-VI, Sy. meta-static condition
No.410 & 411, adenocarcinoma of s of Zone
APIIC pancreas) IV-A.
Formulation
SEZ, Polepally USP Specifications
Village,
Jadcherla 02 years
Mandal,
Mahaboob
Nagar (Dist)

509301, Andhra
Pradesh, India.
41. M/s. Premier Gemtero 200mg Form 5A MHRA. COPP/Fr Deferred
Agencies, Injection Gemcitabine ee sales for the
60-Muslimabad, Dated 13- 200mg certificat submissio
Jamshed Each vial contains:- 11-2014 Powder for e not n of valid
Quarters M.A. Gemcitabine vide diary injection by attached. legalized
Jinnah Road Hydrochloride No. 73 M/s Hospira GMP COPP and
Extension, equivalent to Rs.100,000 certificat Stability
Karachi Gemcitabine 200mg for /- e is not data as per
injection attached. conditions
Manufactured As per Stability of Zone
by (Advanced or met- SRO. data is IV-A.
M/s. Hetero static bladder cancer not as
Labs Limited , in combination with per
Unit-VI, Sy. cisplatin, locally or condition
No.410 & 411, meta-static s of Zone
APIIC adenocarcinoma of IV-A.
Formulation pancreas)
SEZ, Polepally
Village, USP Specifications
Jadcherla
Mandal, 02 years
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
42. M/s. Premier Paclitero 30mg/5ml Form 5A MHRA. COPP Deferred
Agencies, Injection Paclitaxel valid for the
60-Muslimabad, Dy. No 74 6mg/ml Conc. upto 30- submissio
Jamshed Each vial contains:- Dated 13- for solution for 12-2015. n of valid
Quarters M.A. Paclitaxel 11-2014 infusion by legalized
Jinnah Road USP………..30mg/5ml Rs.100,000 M/s Medac Photocop COPP and
Extension, / (5ml, 16.7ml, y of Stability
Karachi.-74800 (Monotherapy for 50ml & GMP data as per
meta-static breast As per 100ml). upto 19- conditions
Manufactured cancer. In SRO 09-2014. of Zone
by combination with Local. IV-A.
M/s. Hetero Gemcitabin for meta- Panataxel Stability
Labs Limited , static adenocarcinoma 100mg, data not
Unit-VI, Sy. of pancreas) 150mg, 300mg as per
No.410 & 411, & 30mg by condition
APIIC USP Specifications M/s s of Zone
Formulation Ferozsons. IV A.
SEZ, Polepally 02 years
Village,

Jadcherla
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
43. M/s. Premier Paclitero 100mg/16.7ml Form 5A MHRA. COPP Deferred

Jamshed Each vial contains:- dated 13- for solution for 12-2015. n of valid
Quarters Paclitaxel 11-2014 infusion by legalized
M.A. Jinnah USP………..100mg/16. Rs.100,000 M/s Medac Photocop COPP and
Road Extension, 7ml / (5ml, 16.7ml, y of Stability
Karachi.-74800 50ml & GMP data as per
(Monotherapy for As per 100ml). valid conditions
M/s. Hetero meta-static breast SRO upto 19- of Zone
Labs Limited , cancer. In Local. 09-2014. IV-A.
Unit-VI, Sy. combination with Panataxel
No.410 & 411, Gemcitabin for meta- 100mg, Stability
APIIC static adenocarcinoma 150mg, 300mg data not
Formulation of pancreas) & 30mg by as per
SEZ, Polepally M/s condition
Village, USP Specifications Ferozsons. s of Zone
Jadcherla IV A.
Mandal, 02 years
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
44. M/s. Premier Paclitero 300mg Form 5A MHRA. COPP Deferred

Jamshed Each vial contains:- dated 13- for solution for 12-2015. n of valid
Quarters Paclitaxel 11-2014 infusion by legalized
M.A. JinnahUSP………..300mg/50 Rs.100,000 M/s Medac Photocop COPP and
Road Extension, ml /- (5ml, 16.7ml, y of Stability
Karachi 50ml & GMP data as per
(Monotherapy for As per 100ml). valid conditions
M/s. Hetero meta-static breast SRO upto 19- of Zone
Labs Limited , cancer. In Local. 09-2014. IV-A.
Unit-VI, Sy. combination with Panataxel Stability
No.410 & 411, Gemcitabin for meta- 100mg, data is
APIIC static adenocarcinoma 150mg, 300mg not as
Formulation of pancreas) & 30mg by per

SEZ, Polepally M/s condition
Village, USP Specifications Ferozsons. s of Zone
Jadcherla IV A.
Mandal, 02 years
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
45. M/s. Mekinist 0.5mg Tablets Form 5A MHRA. The firm Approved
GlaxoSmithKlin Mekinist f/c has as per
e Pakistan Each film coated tablets 03-12-2014 tablet 0.5mg & provided Import
Limited, 35- contains:- vide diary 2mg by M/s 2 Policy for
Dockyard Road, Trametinib dimethyl/ No.188 Novartis. COPPs. Finished
West Wharf, sulfoxide equivalent to Rs.50,000/- The first Drugs
Karachi. 0.5mg trametinib COPP
As per PRC issued
Manufactured Mono therapy or in dated 19-
by :- combination with 09-2014
M/s. Debrafenib for by EMA
GlaxoSmithKlin patients with un- says that
e Manufacturing resectable or met- “The
S.p.A., Strada static melanoma product
Provinciale is not
Asolana, 90, New molecule. actualy
43056 San Polo in the
di Torrile, Manufacturer’s market
Parma, Italy. Specifications of
Primary & exportin
Secondary 02 years g
Packaging country
Site:- ”
M/s. Glaxo GMP
Wellcome S.A. complian
Avenida t as per
Extremadura, 3, COPP.
09400 Aranda The 2nd
de Duero, COPP
Burgos, Spain. issued
Market dated 21-
Authorization 09-2015
Holder says that
Glaxo Group the
Ltd, 980 Great product
West Road, is on free
Brentford, sale in
Middlesex TW8 the

9GS, United exportin
Kingdom. g
country.
46. M/s. Mekinist 2mg Tablets Form 5A MHRA. The firm Approved
GlaxoSmithKlin Mekinist f/c has as per
e Pakistan Each film coated tablets Dy. No 187 tablet 0.5mg & provided Import
Limited, 35- contains:- Dated 02- 2mg by M/s 2 Policy for
Dockyard Road, Trametinib dimethyl/ 12-2014 Novartis. COPPs. Finished
West Wharf, sulfoxide equivalent to Rs.50,000/- The first Drugs
Karachi. 2mg trametinib COPP
As per PRC issued
Manufactured Mono therapy or in dated 19-
by :- combination with 09-2014
M/s. Debrafenib for by EMA
GlaxoSmithKlin patients with un- says that
e Manufacturing resectable or met- “The
S.p.A., Strada static melanoma product
Provinciale is not
Asolana, 90, New molecule. actualy
43056 San Polo in the
di Torrile, Manufacturer’s market
Parma, Italy. Specifications of
Primary & exportin
Secondary 02 years g
Packaging country
Site:- ”
M/s. Glaxo GMP
Wellcome S.A. complian
Avenida t as per
Extremadura, 3, COPP.
09400 Aranda The 2nd
de Duero, COPP
Burgos, Spain. issued
Market dated 21-
Authorization 09-2015
Holder says that
Glaxo Group the
Ltd, 980 Great product
West Road, is on free
Brentford, sale in
Middlesex TW8 the
9GS, United exportin
Kingdom. g
country.

47. M/s. Care Microbar HD Powder Form 5A COPP Deferred
Takers the for Suspension valid up for the
Healthcare Each 100gm contains:- Dy No. 233 to 2-5- confirmati
Company, Barium Sulpahte dated 15- 2015. on as X-
131-B, M.A. B.P…………..95gm 12-2014 GMP Ray
Johar Town, Palatable Base Rs.50,000/- vslif upto Contrast
Lahore. q.s……………..100gm 2-5- Media is
(X-Ray Contrast Media) 2015. not
M/s. Eskay 03 years included
Speciality for priority
Chemicals, considerati
Plot No. 207-B on
& 208 Surat
Special
Economic Zone,
Road No.-4,
G.I.D.C., At &
Post Sachin,
Surat, India.
48. M/s. Incruse Ellipta Form-5A Already Approved

GlaxoSmithKlin approved as per
e Pakistan Dry Powder Inhaler Dy. No: in 254th Import
Limited, 35- Each pre-dispensed 234 dated meeting Policy for
Dockyard Road, dose contains. 15-12-2014 but later Finished
West Wharf, Umeclidinium 50,000/- on Drugs
Karachi-74000. (equivalent to 74.2 mcg dated 15- deleted
of umecidinium 12-2014 by the
Manufactured bromide)…….62.5mcg Board in
by Will be 256th
M/s. Glaxo (Long acting muscarinic submitted meeting
Operations UK antagonist (LAMA) later as the
Limited, Priory decision
Street, Ware New molecule. on new
Hertfordshire molecule
SG12 ODG, s is not
United clear.
Kingdom. COPP
Issued on
Market 28-10-
Authorization 2014
Holder
M/s Glaxo

Group Ltd, 980
Great West
Road, Brentford,
Middlesex TW8
9GS, United
Kingdom.
49. M/s. Novartis Zykadia 150mg Hard Form 5A MHRA. COPP Deferred
Pharma Gelatin Capsules Zykadia valid for the
(Pakistan) Dy. No 243 150mg capsule upto 07- clarificatio
Limited, 15 Each capsule contains:- dated 17- by M/s 07-2016 n
West Wharf, Ceritinib…………..150 12-2014 Novartis. issued by regarding
Karachi. mg Rs.50,000/- US FDA. approval
status of
Manufactured (Anaplastic lymphoma Rs.450,000 product by
By kinase positive /50’s regulataor
M/s. Novartis advanced non small capsules. y authority
Pharma Stein cell lung cancer) of
AG, Stein, Switzerlan
Switzerland. Manufacturer’s d.
Specifications
24 months
50. M/s. Novartis Jakavi 10mg Tablet Form 5A MHRA. Jakavi Dossier Deferred
Pharma 5, 10, 15 & is for the
(Pakistan) Each tablet contains:- Dy No. Nil 20mg by M/s photocop verificatio
Limited, 15 Ruxolitinib………..10 dated 24- Novartis. y fee n of fee,
West Wharf, mg 12-2014 Rs.50,00 submissio
Karachi. Rs.50,000/- 0 is n valid
(Myelo fibrosis, photocop legalized
M/s. Novartis polycythemia vera) Rs.418520/ y. COPP
Pharma Stein 56’s tablets Photoco
AG, Stein, Manufacturer’s py COPP
Switzerland. Specifications issued
dated07-
24 months 11-2014.
GMP
complian
t as per
COPP.
Stability
data as
per
condition
s of Zone
IV-B
attached.

51. M/s. PharmEvo Temotero 250mg Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Capsule Temodal 5mg, valid for the
Plot No. A-29, DY. 272 20mg, 100mg, upto 30- submissio
North West Each hard gelatin dated 24- 140mg, 180mg 12-2015. n of
Industrial Zone, capsule contains:- 12-2014 & 250mg by stability
Port Qasim, Temozolomide……… Rs.100,000 M/s Merck Photocop data as per
Karachi …..250mg / y of conditions
Local. GMP of Zone
M/s. Hetero (For newly diagnosed As per Temoside valid IV A and
Labs Limited Glioblastoma SRO 20mg, 100mg upto 19- valid
Unit – VI Sy multiforme & 250mg by 09-2014. legalized
No. 410 & 411, concomitantly with M/s AJ. Mirza. COPP
APIIC radiotherapy) Stability
Formulation is not as
SEZ, Polepally Manufacturer’s per
Village, Specifications condition
Jadcherla s of Zone
Mandal, 02 years IV A.
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
52. M/s. PharmEvo Temotero 5mg Capsule Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Temodal 5mg, valid for the
Plot No. A-29, Each hard gelatin Dy. No 273 20mg, 100mg, upto 30- submissio
North West capsule contains:- dated 24- 140mg, 180mg 12-2015. n of
Industrial Zone, Temozolomide……… 12-2014 & 250mg by stability
Port Qasim, …..5mg Rs.100,000 M/s Merck Photocop data as per
Karachi /- y of conditions
(For newly diagnosed GMP of Zone
Manufactured Glioblastoma As per valid IV A and
By. multiforme SRO upto 19- valid
M/s. Hetero concomitantly with 09-2014. legalized
Labs Limited radiotherapy) COPP
Unit – VI Sy Stability
No. 410 & 411, Manufacturer’s is not as
APIIC Specifications per
Formulation condition
SEZ, Polepally 02 years s of Zone
Village, IV A.
Jadcherla
Mandal,
Mahaboob
Nagar (Dist)

509301, Andhra
Pradesh, India.
53. M/s. PharmEvo Temotero 20mg Form 5A MHRA. COPP Deferred
(Pvt) Ltd., Capsule Temodal 5mg, valid for the
Plot No. A-29, Dy. NO 20mg, 100mg, upto 30- submissio
North West Each hard gelatin 270 Dated 140mg, 180mg 12-2015. n of
Industrial Zone, capsule contains:- 24-12-2014 & 250mg by stability
Port Qasim, Temozolomide……… Rs.100,000 M/s Merck Photocop data as per
Karachi …..20mg /- y of conditions
Local. GMP of Zone
Manufactured (For newly diagnosed As per Temoside valid IV A and
By. Glioblastoma SRO 20mg, 100mg upto 19- valid
M/s. Hetero multiforme & 250mg by 09-2014. legalized
Labs Limited concomitantly with M/s AJ. Mirza. COPP
Unit – VI Sy radiotherapy) Stability
No. 410 & 411, is not as
APIIC Manufacturer’s per
Formulation Specifications condition
SEZ, Polepally 02 years s of Zone
Village, IV A.
Jadcherla
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
54. M/s. PharmEvo Temotero 100mg Form 5A MHRA. Original Deferred

(Pvt) Ltd., Capsule Temodal 5mg, not for the
Plot No. A-29, Dy. No 271 20mg, 100mg, provided. submissio
North West Each hard gelatin dated 24- 140mg, 180mg Photocy n of
Industrial Zone, capsule contains:- 12-2014 & 250mg by COPP stability
Port Qasim, Temozolomide……… Rs.100,000 M/s Merck valid data as per
Karachi …..100mg /- upto 30- conditions
Local. 12-2015. of Zone
Manufactured (For newly diagnosed As per Temoside Photocop IV A and
By. Glioblastoma SRO 20mg, 100mg y of valid
M/s. Hetero multiforme & 250mg by GMP legalized
Labs Limited concomitantly with M/s AJ. Mirza. valid COPP
Unit – VI Sy radiotherapy) upto 19-
No. 410 & 411, 09-2014.
APIIC Manufacturer’s
Formulation Specifications Stability
SEZ, Polepally is not as
Village, 02 years per
Jadcherla condition

Mandal, s of Zone
Mahaboob IV A.
Nagar (Dist)
509301, Andhra
Pradesh, India.
55. M/s. Gene-Tech ADPEM 500 Injection Form 5A MHRA. COPP Deferred
Laboratories, Alimta 100mg valid for the
Head Office. Each vial contains:- Dy No.255 & 500mg upto 08- submissio
246/B, PECHS, Pemetrexed Disodium R&I dated powder for 02-2015. n of
Block-6, eq. to 24-12-2014 conc. For No. following
Karachi. Pemetrexed……..…… Rs.100,000 infusion by HFW-H a. Stability
……500mg /- M/s Eli Lilly. (DRUG) data as per
Manufactured Mannitol 22/05 conditions
by USP…………..500mg Rs.70,000/ Local. Alimta (Vol.VI) of Zone
M/s. Adley vial 100mg & IV A
Formulations, (Malignant pleural 500mg by M/s GMP b.Sole
Vill. Kotla, PO. mesothelioma non- Eli Lilly. certificat agency
Borotiwala, small cell lung cancer) e valid agreement
Tehsil: Baddi, upto 08- c. Drug
Distt. Solan, 24 months 02-2015 Sales
Himachal (H.P) No. License.
Pradesh, India. HFW-H
(DRUG)
22/05
(Vol.VI)
56. M/s. Gene-Tech CAPAD 500mg Tablets Form 5A MHRA. COPP Deferred
Laboratories, Capecitabine valid for the
Head Office. Each film coated tablet Dy No.256 500mg f/c by upto 08- submissio
246/B, PECHS, contains:- R&I dated M/s Accord. 02-2015. n of
Block-6, Capecitabine 24-12-2014 No. following
Karachi. USP…………..500mg Rs.100,000 Local. Xeloda HFW-H a. Stability
/- 500mg by M/s (DRUG) data as per
Manufactured (adjuant treatment of Roche. 22/05 conditions
by patients following Rs.2083/10 (Vol.VI) of Zone
M/s. Adley surgery of stage III ’s IV A
Formulations, colon cancer, meta- GMP b.Sole
Vill. Kotla, PO. static colo-rectal certificat agency
Borotiwala, cancer) e valid agreement
Distt. Solan, 24 months 02-2015 Sales
(DRUG)
22/05

(Vol.VI)
57. M/s. Gene-Tech BORTIAD 2.0mg Form 5-A COPP Deferred

Laboratories, Injection valid for the
Head Office. Dy No.257 upto 08- submissio
246/B, PECHS, Each vial contains:- R&I dated 02-2015. n of
Block-6, Bortezomib…………… 24-12-2014 No. following
Karachi. …..2.0mg Rs.100,000 HFW-H a.
/- (DRUG) Approval
Manufactured (Lymphocytic 22/05 status by
by leukemia, indolent Not (Vol.VI) reference
M/s. Adley non-Hodgkin’s mentioned regulatory
Formulations, lymphoma, multiple GMP authorities
Vill. Kotla, PO. myeloma) certificat b.Stability
Borotiwala, e valid data as per
Tehsil: Baddi, 24 months upto 08- conditions
Distt. Solan, 02-2015 of Zone
Himachal (H.P) No. IV A.
Pradesh, India. HFW-H c.Sole
(DRUG) agency
22/05 agreemend
(Vol.VI) d.Drug
Approval Sales
status in License.
reference
countries
is not
provided.
Internati
onaly the
product
is present
as
mannitol
boronic
ester.
Clarificat
ion
whether
the
product
is in
liquid
form or
powder
form.

58. M/s. Gene-Tech ADGEF 250mg Tablet Form 5-A
MHRA. Iressa COPP Deferred
Laboratories, 250mg f/c valid for the
Head Office. Each film coated tablet Dy No.261 tablet by M/s upto 08- submissio
246/B, PECHS, contains:- R&I dated AstraZeneca. 02-2015. n of
Block-6, Gefitinib……………25 24-12-2014 No. following
Karachi. 0mg Rs.100,000 Local. HFW-H a. Stability
/- (DRUG) data as per
Manufactured (Advanced or meta- 22/05 conditions
by static non small cell Rs.140,000 (Vol.VI) of Zone
M/s. Adley lung cancer) /15’s pack IV A
Formulations, GMP b.Sole
Vill. Kotla, PO. 24 months certificat agency
Borotiwala, e valid agreement
Distt. Solan, 02-2015 Sales
(DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
59. M/s. Gene-Tech ADMINE 100mg Tablet Form 5-A MHRA. COPP Deferred
Laboratories, Glivec 100mg valid for the
Head Office. Each film coated tablet Dy No.259 & 400mg f/c upto 08- submissio
246/B, PECHS, contains:- R&I dated by M/s 02-2015. n of
Block-6, Imatinib Mesylate 24-12-2014 Novartis. No. following
Karachi. Eq. to Rs.100,000 HFW-H a. Stability
Imatinib…………100m /- Local. Glivec (DRUG) data as per
M/s. Adley g 100mg & 22/05 conditions
Formulations, Rs.11083/1 400mg by M/s (Vol.VI) of Zone
Vill. Kotla, PO. (Philadelphia 0’s pack Novartis IV A

Borotiwala, chromosome positive Pharma. GMP b.Sole
Tehsil: Baddi, chronic myeloid certificat agency
Distt. Solan, leukemia) e valid agreement
Himachal (H.P) upto 08- c. Drug
Pradesh, India. Manufacturer’s 02-2015 Sales
Specifications No. License.
HFW-H
24 months (DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
60. M/s. Gene-Tech ADMINE 400mg Tablet Form 5-A MHRA. COPP Deferred
Laboratories, Glivec 100mg valid for the
Head Office. Each film coated tablet Dy No.260 & 400mg f/c upto 08- submissio
246/B, PECHS, contains:- R&I dated by M/s 02-2015. n of
Block-6, Imatinib Mesylate 24-12-2014 Novartis. No. following
Karachi. Eq. to Rs.100,000 HFW-H a. Stability
Imatinib…………400m /- Local. Glivec (DRUG) data as per
M/s. Adley g 100mg & 22/05 conditions
Formulations, Rs.46667/1 400mg by M/s (Vol.VI) of Zone
Vill. Kotla, PO. (Philadelphia 0’s pack Novartis IV A
Borotiwala, chromosome positive Pharma. GMP b.Sole
Tehsil: Baddi, chronic myeloid certificat agency
Distt. Solan, leukemia) e valid agreement
HFW-H
24 months (DRUG)
22/05
(Vol.VI)
Stability

data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
61. M/s. Gene-Tech ERLOTAD 100mg Form 5A MHRA. COPP Deferred

Laboratories, Tablet Tarceva 25mg, valid for the
Head Office. Dy No. 258 100mg & upto 08- submissio
246/B, PECHS, Each film coated tablet R&I dated 150mg f/c 02-2015. n of
Block-6, contains:- 24-12-2014 tablets by M/s No. following
Karachi. Erlotinib Hydochloride Rs.100,000 Roche. HFW-H a. Stability
Eq. to /- (DRUG) data as per
M/s. Adley Erlotinib…………….10 Local. Tarceva 22/05 conditions
Formulations, 0mg As per 25mg, 100mg (Vol.VI) of Zone
Vill. Kotla, PO. SRO & 150mg f/c IV A
Borotiwala, (Non small cell lung tablets by M/s GMP b.Sole
Tehsil: Baddi, cancer or pancreatic Roche. certificat agency
Distt. Solan, cancer) e valid agreement
HFW-H
24 months (DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.

62. M/s. Gene-Tech ERLOTAD 150mg Form 5A MHRA. COPP Deferred
Laboratories, Tablet Tarceva 25mg, valid for the
Head Office. Dy No. 254 100mg & upto 08- submissio
246/B, PECHS, Each film coated tablet R&I dated 150mg f/c 02-2015. n of
Block-6, contains:- 24-12-2014 tablets by M/s No. following
Karachi. Erlotinib Hydochloride Rs.100,000 Roche. HFW-H a. Stability
Eq. to /- (DRUG) data as per
Manufactured Erlotinib…………….15 Local. Tarceva 22/05 conditions
by 0mg As per 25mg, 100mg (Vol.VI) of Zone
M/s. Adley SRO & 150mg f/c IV A
Formulations, (Non small cell lung tablets by M/s GMP b.Sole
Vill. Kotla, PO. cancer or pancreatic Roche. certificat agency
Borotiwala, cancer) e valid agreement
Distt. Solan, Manufacturer’s 02-2015 Sales
Himachal (H.P) Specifications No. License.
Pradesh, India.. HFW-H
24 months (DRUG)
22/05
(Vol.VI)
Stability
data as
per
condition
s of Zone
IV-A is
not
provided.
Sole
agency
agreeme
nt is not
provided.
63. M/s. Group 9 Sport Vis TM pre-filled Form 5A Free Deferred

Pakistan, syringe for peri-articular sales for the
MI, 19-C Rahat injection Dy 284 certificat clarificatio
Commercial Each pre-filled syringe dated 29- e valid n as the
Lane 2, DHA contains:- 12-2014 upto complete
Phase-6, 1.2ml 1% low Rs.50,000/- dated 01- descriptio
Karachi. molecular weight 10-2016 n as
sodium hyaluronatein by swiss applied on
M/s. MDT phosphate buffered medic Form 5A

Int,SA, saline but is not
Rue du 31 (Peri-articular injection) complete same as
Decembre, 36 descripti mentioned
1207 Geneva, 36 months on as on free
Switzerland. applied sales
Manufacturing New molecule on Form certificate.
site address: 5A is not Firm will
Hyaltech Ltd., mentione provide
Starlaw d on free either
Business Park sales. CoPP or
EH54 8SF Medical FSC and
Livingston, Device GMP
United
Kingdom.
64. M/s. Langene Letrax 2.5mg Tablet Form 5A
MHRA. Femra Non Deferred
Biotech, 2.5mg f/c legalized for the
Head Office. Each film coated tablet Dy No. 01 tablet by M/s copy of submissio
246/B, PECHS, contains:- dated 01- Novartis. COPP n of
Block-6, Letrozole 01-2015 dated 17- following
Karach-75400. (micronized)…….……. Rs.100,000 Local. Femra 09-2014 a. Valid
.2.5mg /- 2.5mg by M/s attached. legalized
M/s. Aburaihan Novartis. DSL is COPP.
Pharmaceutical (Adjuant treatment of Rs.6000/30 not b. Drugs
Company, post-menopausal ’s Pack. attached. Sales
No.1, Hojr ebne women with harmone Stability License.
Oday Ave, recpotor positive data as c. Stability
Tehranpars invasive early breast per data as per
Tehran-I.R. Iran. cancer) condition conditions
s of Zone of Zone
Manufacturer’s IV-A is IV-A
Specifications not d. Sole
provided. agency
03 years Sole agreement.
agency
agreeme
nt is not
provided.
65. M/s. Care Microbar CAT 2 Liquid Form 5A COPP Deferred

Takers the Suspension valid for the
Healthcare Each 100ml contains:- Dy No. 12 upto 2-5- confirmati
Company, 131- Barium Sulpahte dated 08- 2015. on as X-
B, M.A. Johar B.P…………..7gm 01-2015 GMP Ray
Town, Lahore. Palatable Base Rs.50,000/- valid Contrast
q.s……………..100ml upto 2-5- Media is
M/s. Eskay (X-Ray Contrast Media) 2015. not

Speciality 03 years included
Chemicals, for priority
Plot No. 207-B considerati
& 208 Surat on
Special
Economic Zone,
Road No.-4,
G.I.D.C., At &
Post Sachin,
Surat, India.
66. M/s. Care Microbar for Enema Form 5A COPP Deferred
Takers the (Disposable Kit) valid for the
Healthcare Powder for Rectal Dy No. 11 upto 2-5- confirmati
Company, 131- Suspension dated 08- 2015. on as X-
B, M.A. Johar Each 100gm contains:- 01-2015 GMP Ray
Town, Lahore. Barium Sulpahte Rs.50,000/- valid Contrast
B.P…………..92gm upto 2-5- Media is
M/s. Eskay Base 2015. not
Speciality q.s…………………… included
Chemicals, ….100gm for priority
Plot No. 207-B (X-Ray Contrast Media) considerati
& 208 Surat 03 years on
Special
Economic Zone,
Road No.-4,
G.I.D.C., At &
Post Sachin,
Surat, India.
67. M/s. PharmEvo Iritero Injection Form 5A MHRA. COPP/Fr Deferred

(Pvt) Ltd., 40mg/2ml Campto ee sales for the
Plot No. A-29, Dy. No 14 20mg/ml, certificat submissio
North West Each vial contains:- dated 08- conc. For e is not n of
Industrial Zone, Irinotecan 01-2015 solution 40mg, attached. following
Port Qasim, Hydrochloride Rs.100,000 100mg, & GMP a. Stability
Karachi …….40mg /- 300mg. certificat data as per
e is not conditions
Manufactured (Advanced Colorectal As per attached. of Zone
By. cancer) SRO Stability IV-A.
M/s. Hetero data is b. Valid
Labs Limited Manufacturer’s not as Legalized
Unit – VI Sy Specifications per CoPP.
No. 410 & 411, 03 years condition
APIIC s of Zone
Formulation IV-A.
SEZ, Polepally

Village,
Jadcherla
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
68. M/s. PharmEvo Iritero Injection Form 5 A MHRA. COPP/Fr Deferred

(Pvt) Ltd., 100mg/5ml Campto ee sales for the
Plot No. A-29, Dy. No 13 20mg/ml, certificat submissio
North West Each vial contains:- dated 08- conc. For e is not n of
Industrial Zone, Irinotecan 01-2015 solution 40mg, attached. following
Port Qasim, Hydrochloride Rs.100,000 100mg, & GMP a. Stability
Karachi …….100mg /- 300mg. certificat data as per
e is not conditions
Manufactured (Advanced Colorectal As per attached. of Zone
By. cancer) SRO Stability IV-A.
M/s. Hetero data is b. Valid
Labs Limited not as Legalized
Unit – VI Sy Manufacturer’s per CoPP.
No. 410 & 411, Specifications condition
APIIC s of Zone
Formulation 03 years IV-A.
SEZ, Polepally
Village,
Jadcherla
Mandal,
Mahaboob
Nagar (Dist)
509301, Andhra
Pradesh, India.
69. M/s. Biomedics Ipraneb 500 mcg /2ml Form 5A

MHRA. COPP Approved
Medical System, Nebuliser Solution Atrovent 2ml issued by as per
F-597, F-Block, Dy No.20 250mcg/ml by Malaysia Import
Satellite Town, Each 2ml vial contains:- dated 14- M/s Drug Policy for
Rawalpindi. Ipratropium 01-2015 Boehringer. Control Finished
Bromide……………… Rs.50,000/- Authorit Drugs
Manufactured …….500mcg/2ml y on
by Rs.450/Via dated 31-
M/s. Ain (Anticholinergics) l 2ml 10-2014
Medicare New Formulation vide
SDN.BHD, Number
Jalan 6/44, Manufacturer’s 1879/201
Kawasan Specifications 4.

Perindustrian GMP
Pengkalan 02 years certificat
Chepa 2, 16100 e issued
Kota Bharu dated 29-
Kelantan Darul 10-2014
Naim, Malaysia. vide No.
413/14
valid
upto 04-
01-2017
Stability
data on
the
condition
s of
water
loss is
attached
being
semi
permeabl
e
container
s.
70. M/s. Ali Gohar Simbrinza Eye Drops, Form 5-A EMA. Original Deferred
& Company Suspension Dy No.33 Simbrinza by legalized for the
(Pvt) Limited, Contains:- 23-02-2015 M/s Alcon COPP submissio
State Life Brinzolamide…………. Rs.50,000/- was n of
Building 1B, I.I 10mg/ml issued by stability
Chundrigar Brimonidine Tartrate EMA on data as per
Road, Karachi. 2mg eq.to dated conditions
Manufacture by. Brimonidine…….1.3mg 01-09- of zone IV
M/s. Alcon- / ml 2014. A.
Couveur N.V. 24 months GMP
Rijksweg 14, B- (Ophthalmic) issued by
2870, Puurs, balgium
Belgium. New Formulation on dated
Site for Quality 17-05-
Control, Primary 2013
& Secondary Stability
Packaging. data not
M/s Alcon as per
Research Ltd Zone IV
(Subsidiary of A.
Alcon
Laboratories,

Inc), ASPEX
manufacturing
Facility, 6201
South Freeway,
Fort Worth, TX
76134-2099,
USA
Market
Authorization:
Alcon
Laboratories
(UK) Ltd,
Frimley
Business Park,
Frimley,
Camberley
GU16 7SR,
United
Kingdom.
71. M/s. Novartis Signifor LAR Powder Form 5-A MHRA. Orignal Deferred
Pharma for Suspension for Signifor legalized for the
(Pakistan) Injection Dy No.314 Powder for COPP clarificatio
Limited, 15 R&I dated injection was n/submissi
West Wharf, Each vial contains:- 29-05-2015 20mg, 40mg issued by on of
Karachi. Pasireotide……………. Rs.50,000/- & 60mg by Europea following
20mg M/s Novartis n a. Status
Manufactured (as pasireotide pamoate) Rs.450,000 Medicine of
By / 1’s Agency manufactu
M/s. Novartis (Treatment of on ring site
Pharma AG, Acromegaly) 19-02- for the
Lichtstrasse 35, New Molecule 2015. manufactu
4056 Basel, The ring of
Switzerland. Manufacturer’s GMP sterile
Market Specifications certificat products
Authorization: e says as GMP
Novartis 36 months that the states that
Europharm site is site is
Limited, licensed licensed to
Wimblehurst to manufactu
Road, Horsham, manufact re
West Sussex ure medicinal
RH12 5AB, medicina products
United Kingdom l excluded
products sterile
excluded products.
sterile b.

products. Registratio
n
applicatio
n of
Solvent on
separate
applicatio
n.
Limited, 15 dated 29- injection was n/submissi
West Wharf, Each vial contains:- 05-2015 20mg, 40mg issued by on of
By /1’s Agency manufactu
M/s. Novartis (Treatment of on ring site
Pharma AG, Acromegaly) (36 19-02- for the
Lichtstrasse 35, months) 2015. manufactu
4056 Basel, New Molecule The ring of
Switzerland. GMP sterile
Market Manufacturer’s certificat products
Authorization: Specifications e says as GMP
Novartis that the states that
Europharm 36 months site is site is
products sterile
excluded products
sterile b.
n
applicatio
n of
Solvent on
separate
applicatio
n.

Limited, 15 R&I dated injection was n/submissi
West Wharf, Each vial contains:- 29-05-2015 20mg, 40mg issued by on of
By (Treatment of 0/1’s Agency manufactu
M/s. Novartis Acromegaly) on ring site
Pharma AG, New Molecule 19-02- for the
Lichtstrasse 35, 2015. manufactu
4056 Basel, Manufacturer’s The ring of
Switzerland. Specifications GMP sterile
Market certificat products
Authorization: 36 months e says as GMP
Novartis that the states that
Europharm site is site is
products sterile
excluded products
sterile b.
n
applicatio
n of
Solvent on
separate
applicatio
n.
74. M/s. ICIMartxel 500mg Form 5A MHRA. COPP Approved
Pakistan Lyophilized Powder for Alimta 100mg issued on as per
Limited, injection solution for Dy. No & 500mg 29-12- Import
Life Sciencesintravenous infusion 330 dated powder for 2014 by Policy for
Business, ICI 01-06-2015 conc. For Argentin Finished
House, 5 West Each vial contains:- Rs.100,000 infusion by a is valid Drugs.
Wharf, Karachi Pemetrexed as /- M/s Eli Lilly. for 12 Firm will
disodium………….500 month. provide
Manufactured mg As per Local. Alimta valid
by SRO 100mg & GMP legalized
M/s. Eriochem (Malignant pleural 500mg by M/s complian CoPP and
S.A. mesothelioma non- Eli Lilly. t as per chairman
Ruta 12, Km small cell lung cancer) COPP. will permit
452 (3107), further

Colonia Manufacturer’s Stability processing
Avellaneda, Specifications data as of case
Departamento per
Parana, Entre 24 months condition
Rios, Argentina. s of Zone
IV-B.
75. M/s. Pharmatec Oramorph 2mg/ml Form 5A MHRA. Certificat Approved
Pakistan (Pvt) Syrup Dy. No 320 Oramorph e of as per
Ltd., D-86/A dated 01- 10mg/5ml by Medicina Import
Mangopir Road, Each ml contains:- 06-2015 M/s l product Policy for
S.I.T.E, Karachi. Morphine Rs.100,000 Boehringer. 03-03- Finished
Manufactured Sulphate………..2mg /- 2015. Drugs
By GMP
M/s. (Natural Opium Rs.648/100 issued
L.MOLTENI & Alkaloids) ml dated 07-
C, DEI F.LLI 22-2014.
ALITTI New formulation
SOCIETA’DI
ESERCIZIO Manufacturer’s
S.P.A. S.S.67 Specifications
(TOSCO
ROMAGNOLA 36 months
) LOCALITA
GRANATIERI-
50018, ITALY.
76. M/s. Pharmatec Oramorph 20mg/ml Form 5A MHRA. Certificat Approved
Pakistan (Pvt) Oral Solution Dy. No 319 Oramorph e of as per
Ltd., D-86/A dated 01- 20mg/ml by Medicina Import
Mangopir Road, Each ml contains:- 06-2015 M/s l product Policy for
S.I.T.E, Karachi. Morphine Rs.100,000 Boehringer 03-03- Finished
/ Sulphate………..20mg /- 2015. Drugs
Manufactured GMP
By (Natural Opium Rs.829/20 issued
M/s. Alkaloids) ml dated 07-
L.MOLTENI & 22-2014.
C, DEI F.LLI New formulation
ALITTI
SOCIETA’DI Manufacturer’s
ESERCIZIO Specifications
S.P.A. S.S.67
(TOSCO 36 months
ROMAGNOLA
) LOCALITA
GRANATIERI-
50018, ITALY.
77. M/s. Merixil Biopac 30mg/5ml Form 5A MHRA. COPP Approved

Pharma, Injection Dy No. 349 Paclitaxel issued on as per
Office # 28, dated 15- 6mg/ml Conc. 11-08- Import
Second Floor, Each ml contains:- 06-2015 for solution for 2014 by Policy for
Rose Plaza, I-8 Paclitaxel………….…6 Rs.100,000 infusion by Health Finished
Markaz, mg . M/s Medac Canada. Drugs
Islamabad. (5ml, 16.7ml,
Manufactyured (Monotherapy for As per 50ml & GMP
By meta-static breast SRO. 100ml). Complia
M/s. Biolyse cancer. In nt as per
Pharma combination with Local. COPP.
Corporation, 59 Gemcitabin for meta- Panataxel
Welland Vale static adenocarcinoma 100mg,
Road, ST of pancreas) 150mg, 300mg
Catharines & 30mg by
Ontario L2S M/s
3Y2, Canada. USP Specifications Ferozsons.
30 months
78. M/s. Genome Wego Single 09-07-2015 (Photoco Deferred
Pharmaceuticals Disposable Blood Bag Rs.50,000/- py) of for the
(Pvt) Ltd., Plot # Each 100ml of CPDA Certificat submissio
16/1, Phase IV, contains:- e for n of
Industrial Estate, Citric acid Exportati following
Hattar, Distt, monohydrate……..…0. on of a. Valid
Haripur./ 327g Medical legalized
Sodium citrate Products COPP
M/s. Shandong dihydrate…………2.63 issued by b. Stability
Weigao Group g Governm data as per
Medical Sodium biphosphate ent of water loss
Polymer Co., monohydrate…0.222g China on conditions
Ltd. 10 Mashan Dextrose dated.20- as per ICH
Road High-Tech monohydrate….3.19g 05-2014 Guidelines
Industrial Adenine………0.0275g Original .
Development Water for GMP
Zone, Weihai, injection…………q.s is not
Shandong (Medical consumables) attached
Province,
People’s Blood Bag
Republic of
China. 02 years
79. M/s. Genome Wego Double 09-07-2015 (Photoco Deferred


Hattar, Distt, monohydrate.…0.327g on of a. Valid
Haripur./ Sodium citrate Medical legalized
M/s. Shandong dihydrate………2.63g Products COPP
Weigao Group Sodium biphosphate issued by b. Stability
Medical monohydrate…..0.222g Governm data as per
Polymer Co., Dextrose ent of water loss
Ltd. 10 Mashan monohydrate….3.19g China on conditions
Road High-Tech Adenine………0.0275g dated.20- as per ICH
Industrial Water for 05-2014 Guidelines
Development injection……………q.s Original .
Zone, Weihai, (Medical consumables) GMP
Shandong is not
Province, Blood Bag attached
People’s
Republic of 02 years
China.
80. M/s. Genome Wego Triple Disposable 09-07-2015 (Photoco Deferred

Pharmaceuticals Blood Bag Rs.50,000/- py) of for the
Hattar, Distt, monohydrate…0.327g on of a. Valid
Medical monohydrate…0.222g Governm data as per
Ltd. 10 Mashan monohydrate…..3.19g China on conditions
Road High-Tech Adenine……0.0275g dated.20- as per ICH
Development injection…………q.s Original .
Shandong is not
People’s
China.
81. M/s. Genome Wego Quadruple 09-07-2015 (Photoco Deferred

Hattar, Distt, monohydrate…0.327g on of a. Valid

Medical monohydrate…0.222g Governm data as per
Ltd. 10 Mashan monohydrate…3.19g China on conditions
Road High-Tech Adenine…0.0275g dated.20- as per ICH
Development injection…………q.s Original .
Shandong is not
People’s
China.
82. M/s. Bayer Sivextro 200mg Film Form 5-A Original Deferred
Pakistan (Pvt) Coated Tablets legalized for the
Limited, C-21, Dy No.98 COPP submissio
S.I.T.E, Karachi. Each film coated tablet 30-07-2015 was n of
contains:- Rs.50,000/- issued by following
Manufacturing Tedizolid EMA on a.
& Primary, Phosphate……….200m Not dated 22- clarificatio
Secondary g mentioned 05-2015. n of
Packaging and complete
Quality (Oxazolidinone/antibioti The details of
Control by: c) GMP is release site
M/s. Patheon New Molecule issued by as release
Inc. Whitby Health site is not
Regional Manufacturer’s Canda mentioned
Operations Specifications dated 21- on COPP.
(WRO) 111 04-2015
Consumers 03 years valid
Drive Whitby, upto 1
Ontario LIN year.
5Z5, Canada.
Market Release
Authorization. is not
Cubist (UK) mentione
Ltd, Unit 1 d in
Horizon COPP
Business however
Village, 1 the firm
Brooklands has
Road, submitte
Weybridge, d the

Surrey KT13 declarati
ORU, United on for
Kingdom the same.
Released
by:
M/s.
Bayer
Pharma
AG
Mullerstr
asse 178
13353
Berlin,
Germany
83. M/s. Bayer Sivextro Powder for Form 5-A MHRA. Original Deferred
Pakistan (Pvt) Concentrate for Sivextro by legalized for the
Limited, C-21, Solution for infusion Dy No.42 M/s Merck COPP submissio
S.I.T.E, Karachi. 200mg dated 30- was n of
07-2015 issued by following
Manufactured, Each vial contains:- Rs.50,000/- EMA on a.
Quality Tedizolid dated 22- clarificatio
Control & Phosphate……….200m Not 05-2015. n of
Primary g mentioned complete
Packaging by: (Oxazolidinone/antibioti The details of
M/s. Patheon c) GMP is release site
Italia S.p.A. 2 New Molecule issued by as release
Trav. SX Via itlay 21- site is not
Morolense, 5 Manufacturer’s 08-2014. mentioned
03013 Specifications on COPP.
Ferentino, FR, Final
Italy. Site 03 years Release
Responsible for &
quality secondar
Control. y
Redox s.n.c di package
Arosio Antonia site is
e. C., Viale not
Stucchi, 62/26, mentione
20900 Monza d in
(MB), Italy. COPP
Market however
Authorization. the firm
Cubist (UK) has
Ltd, Unit 1 submitte
Horizon d the

Business declarati
Village, 1 on for
Brooklands the same.
Road, Seconda
Weybridge, ry
Surrey KT13 Packagi
ORU, United ng
Kingdom &Releas
ed by:
M/s.
Bayer
Pharma
AG
Mullerstr
asse 178
13353
Berlin,
Germany
.
84. M/s. AJ Mirza Cytomid 250mg Tablet Form 5A MHRA COPP Approved
Pharma (Pvt) Approved valid as per
Ltd., 7-Ground Each uncoated tablet Diary No. upto 16- Import
Floor, Shafi contains:- 179 R&I 10-2016. Policy for
Court, Flutamide dated 20- Finished
Merewether USP………….250mg 08-2015 GMP Drugs
Road, Civil Excipients…………… Rs.100,000 complian
Lines, Karachi. ….q.s. /- t as per
COPP.
Manufactured (Treatment of RS. 4200/-
by Advanced prostate 100’s GMP
M/s. Cipla Ltd., cancer) valid
Verna Industrial upto 16-
Estate, Verna, Manufacturer’s 10-2016.
India. Specifications
85. M/s. Novartis Caflam Capsule Form 5-A COPP Deferred

Pharma Each capsule contains:- Dy No.106 was for the
(Pakistan) Diclofenac 03-08-2015 issued by submissio
Limited, 15 potassium……….50mg Rs.50,000/- Swiss n of
West Wharf, (Anti-inflammatory and 20’s Medic following
Karachi./ analgesic) /Rs.560 Switzerla a.
Product nd on confirmati
Licence New Molecule 26-01- on of
Holder: 2015 approval

M/s. Novartis 30 months Product status in
Pharma Schweiz is on the reference
AG, 6343 Risch, market countries
Switzerland. of as COPP
Address of exportin issued by
Manufacturing g Germany
Site: country. says that
M/s. Catalent The product is
Germany certifyin not on the
Eberbach GmbH g market for
Gammelsbacher authority use in the
Strasse 2 69412 arragge exporting
Eberbach/Baden for countries
, Germany. periodic b.
inspectio clarificatio
n not n of
applicabl regulatory
e. free sales
GMP status in
certificat exporting
e issued country.
by
German
authoriti
es on 07-
11-2013
The
COPP
issued by
Germany
says that
product
is not on
the
market
for use in
the
exportin
g
countries
86. M/s. Novartis Farydak 10mg Capsule Form 5A MHRA. COPP Deferred
Pharma Farydak 10mg, issued by for the
(Pakistan) Each capsule contains:- Dy. No 304 15mg & 20mg US FDA clarificatio
Limited, 15 Panobinostat………..10 Dated 08- by M/s for three n of free
West Wharf, mg 09-2015 Novartis. strengths sales
Karachi. Rs.50,000/- and valid status in

(Multiple Myeloma in upto 31- the
Manufactured combination with Rs.950,000 07-2017. exporting
by Bortezomib & /6’s The country.
M/s. Novartis Dexamethasone). Capsules product
Farmaceutica New Molecule is not
SA, Barbera del available
Valles, Spain. Manufacturer’s for free
Specifications sale in
the
36 months country
of origin.
GMP
issued
dated 12-
03-2013
(Pakistan) Each capsule contains:- Dy. No 302 15mg & 20mg US FDA clarificatio
Limited, 15 Panobinostat………..15 dated 08- by M/s and valid n of free
West Wharf, mg 09-2015 Novartis. upto 31- sales
Karachi. Rs.50,000/- 07-2017. status in
(Multiple Myeloma in The the
M/s. Novartis combination with Rs.125500 product exporting
Farmaceutica Bortezomib & 0/6’s is not country.
SA, Barbera del Dexamethasone). capsules available
Valles, Spain. New Molecule for free
sale in
Manufacturer’s the
Specifications country
of origin.
36 months GMP
issued
dated 12-
03-2013
(Pakistan) Each capsule contains:- Dy. No. 15mg & 20mg US FDA clarificatio
Limited, 15 Panobinostat………..20 301 Dated by M/s and valid n of free
West Wharf, mg 08-09-2015 Novartis. upto 31- sales
Karachi. Rs.50,000/- 07-2017. status in
(Multiple Myeloma in The the
M/s. Novartis combination with Rs. product exporting
Farmaceutica Bortezomib & 1560,000/6 is not country.
SA, Barbera del Dexamethasone). ’s capsule available
Valles, Spain. New Molecule for free

sale in
Manufacturer’s the
Specifications country
of origin.
36 months GMP
issued
dated 12-
03-2013
89. M/s. Lenara 2.5mg Tablets Form 5A

MHRA. Femra COPP Approved
Pharmawell 2.5mg f/c issued as per
(Pvt) Ltd. 244-YEach film coated tablet Dated 15- tablet by M/s dated 30- Import
Block, contains:- 09-2015 Novartis. 06-2015 Policy for
Commercial Letrozole…….2.5mg vide diary vide no. Finished
Area Phase III, No. 399 Local. Femra 2015- Drugs.
DHA, Lahore. (Adjuant treatment of Rs.100,000 2.5mg by M/s D1-1817. Panel shall
post-menopausal /- Novartis. GMP confirm
M/s. women with harmone issued the
Kwangdong recpotor positive Rs.6,0000/ dated 27- anticancer
Pharmaceutical invasive early breast 30’s 07-2015 facility for
Co. Ltd., 114, cancer). vide no. the
Sandan-ro, 2015- manufactu
Pyeongtack-Si, (USP Specs) D1-2068. ring of the
Gyeonggi-do, Stability drug at the
Republic of 36 months data as time of
Kora. per foreign
condition inspection
s of Zone
IV B
attached.
90. M/s. Novartis Entresto to Uperio Form 5A COPP Approved
Pharma 200mg was as per
(Pakistan) Dy No. 329 issued by Import
Limited, 15 Each film coated tablet dated 30- Swiss Policy for
West Wharf, contains:- 09- Medic Finished
Karachi. Sacubitril/Valsartan 2015Rs.50, Switzerla Drugs
226.206mg 000/- nd on
Product (Corresponds to 17-09-
License Sacubtril/Valsartan free Rs.27240/2 2015
Holder:- anhydrous acid) 200mg 8tablets GMP
M/s. Novartis Sacubitril/Valsartan complian
Pharma Stein Sodium salt Hydrate, t as per
AG, Stein, Crystal modification A COPP.
Switzerland. Scubitril/ COPP
Manufacturer: Valsartan 200mg mentioni
M/s. Novartis Corrosponds to ng two

Pharma Stein Sacubitril 97.2mg and manufact
AG, Stein, Valsartan 102.8mg urers
Switzerland. without
(Treatment of Heart detaisl of
M/s. Novartis Failure) manufact
Singapore New Molecule uring
Pharmaceutical 24 months processe
Manaufacturing s.
Ptc. Ltd., 10
Tuas Bay Lane
637461
Singapore,
Singapore.
91. M/s. Highnoon Pirfenex 200mg Tablet Form 5-A COPP Deferred
Laboratories Each film coated tablet Dy No.287 and for the
Limited, 17.5 contains:- 30-09-2015 GMP confirmati
KM, Multan Pirfenidone………200 Rs.100,000 was on of
Road, Lahore. / mg /- issued by approval
M/s. Cipla Ltd., India on status in
Village Malpur, (Idiopathic Pulmonary dated 21- reference
Baddi District Fibrosis) 04-2015 countries.
Solan, Himachal New Molecule valid up
Pradesh, India. to 29-08-
24 months 2017
92. M/s. Merixil Temoeirgen 20mg Form 5A MHRA. COPP Approved

Pharma, Capsules dy. No. 381 Temodal 5mg, issued on as per
Office # 28, dated 09- 20mg, 100mg, 04-02- Import
Second Floor, Each capsule contains:- 10-2015 140mg, 180mg 2015. Policy for
Rose Plaza, I-8 Temozolamide……….2 Rs.100,000 & 250mg by GMP Finished
Markaz, 0mg /- M/s Merck complian Drugs
Islamabad. t as per
Manufactured (For newly diagnosed Local. COPP.
by Glioblastoma As per Temoside
M/s. Eirgen multiforme SRO /5’s 20mg, 100mg
Pharma Ltd. concomitantly with & 250mg by
64/65 Westside radiotherapy) M/s AJ. Mirza.
Business Park
Old Kilmeaden Manufacturer’s
Road, Specifications
Waterford,
Ireland. 24 months
93. M/s. Gene-Tech Osateofil Solution for Form 5A MHRA. COPP Deferred
Laboratories, Injection Bondronat No. for the
Head Office. Dy No. 397 2mg/2ml by 2014- submissio

246/B, PECHS, Each vial contains:- R&I dated M/s Roche 146-1 n of
Block-6, Ibandronate 15-10-2015 issued following
Karachi. Sodium………2mg/2ml Rs.100,000 dated 29- a. Stability
/- 09-2014 data as per
Manufactured (Nitrogen –containing valid conditions
by group of Rs.8650/vi upto 2 of Zone
M/s. Nanjing Bisphosphonates) al years. IV A.
Hencer b. Drugs
Pharmaceutical Prevention of skeletal GMP sales
Co. Ltd., No. 18 muscle events in certificat license
Jichang Road, patients with Breast e valid c. Sole
Lishui Cancer and Bone upto 08- agency
Economic & Metastasis 04-2018 Agreemen
Technological No. t
Development 3 years CN2013
Zone, Nanjing 0099.
City, Jiangsu
Province, China.
94. M/s. Merixil Exemestane Normon Form 5A COPP Deferred
Pharma, 25mg Tablet Dy. No 547 not for the
Office # 28, dated 22- provided. submissio
Second Floor, Each coated tablets 12-2015 n of
Rose Plaza, I-8 contains:- Rs.100,000 following
Markaz, Exemestane…………… /- a. Stability
Islamabad. / 25mg data as per
M/s. As per ICH
Laboratorios (Treatment of SRO/3x10’ guidelines
Normon, S.A. postmanupausal s tablets b. Valid
Ronda De woman with oestrogen legalized
Valdecarrizo, 6, positive invasive COPP.
Tres Cantos, breast cancer)
28760, Madrid,
Spain. Manufacturer’s
Specifications
24 months
95. M/s. Merixil Zoledronic Acid Form 5A MHRA. COPP Approved
Pharma, Normon 4mg/5ml Zoledronic issued on as per
Office # 28, Injectable Dy. No. Acid 4mg/5ml 24-02- Import
Second Floor, 546 R&I by M/s 2016. Policy for
Rose Plaza, I-8 Each 5ml concentrate dated 22- Intrapharm. Finished
Markaz, vial contains:- 12-2015 GMP Drugs
Islamabad. Zoledronic acid Rs.100,000 complian
Manufactured Monohydrate 4.264mg /- t as per
By eq to zoledronic COPP.
M/s. acid……….4mg As per

Laboratorios SRO GMP
Normon, S.A. (Prevention of skeletal issued
Ronda De related events (e.g 13-06-
Valdecarrizo, 6, tumor induced 2014.
Tres Cantos, hypercalcemia) in
28760, Madrid, adult patients with
Spain. advanced
malignancies involving
bone).
Manufacturer’s
Specifications
24 months
96. M/s. Merixil Ondansetron Normon Form 5A MHRA.Ondan COPP Approved
Pharma, 8mg Injection Dy. No 548 setron 2mg/ml issued on as per
Office # 28, Dated 22- by M/s 25-02- Import
Second Floor, Each 4ml vial contains:- 12-2015 Hameln 2016. Policy for
Rose Plaza, I-8 Ondansetron…………. Rs.100,000 Finished
Markaz, 8mg /- GMP Drugs
Islamabad. (as hydrochloride Complia
Manufactured dihydrate) As per nt as per
by SRO/ 1x5 COPP.
M/s. Anti emetic for ampoules
Laboratorios chemotherapy induced GMP
Normon, S.A. emesis. issued
Ronda De dated 13-
Valdecarrizo, 6, 06-2014.
Tres Cantos, Manufacturer’s
28760, Madrid, Specifications
Spain. 36 months
97. M/s. Medi Mark Xmeron 50mg Injection Form 5-A China Deferred
Pharmaceuticals Each ml contains:- Dy No. Council for
, Rocuronium 23-12-2015 for the confirmati
Liaqut Chowk, Bromide……..10mg Rs.100,000 Promotio on
Sahiwal./ (Muscle relaxants, /- n of whether
M/s. Zhejiang peripherally acting Internati formulatio
Xianju agents) onal n is
Pharmaceuticals 24 months Trade already
Co. Ltd., No.6, china registered
Xingye Road, chamber or
Modern Block, of otherwise
Ecnomic Zone, internati
Xianju, onal
Zhejiang, China. commerc
e issued

Original
legalized
COPP
25-09-
2015
valid
upto 24-
09-2016.
FSC
issued by
Xianju
Food and
Drug
Administ
ration of
China
25-09-
2015
valid
upto 24-
09-2016
98. M/s. Revive Oncotar-500 Injection Form 5A MHRA. Free sale Approved
Health Care, Cytarabine issued as per
Office 503, 5th Each ml contains:- Dy. NO 500mg/5ml by dated 26- Import
Floor, 6 Main Cytarabine 616 dated M/s Hospira. 02-2016. Policy for
Gulberg, Jail BP…………….100mg 31-12-2015 COPP Finished
Road, Lahore. Rs.50,000/- Local. valid up Drugs
(Acute myeloid & 50,000 Cytarine to 10-05-
Manufactured leukaemia and for dated 24- 500mg by M/s 2017
by other acute leukaemias 06-2016. Atco
M/s. United for children and adults Photocop
Biotech (P) ) y of
Limited, As per PRC GMP is
Bagbania, USP Specifications legalized
Baddi-Nalagarh 2 years valid
Road, District- upto 17-
Solan (Himachal 09-2017.
Pradesh)
174101, India.
99. M/s. Revive Egymelan 50mg Form 5A MHRA. COPP Approved

Health Care, Injection Melphalan valid as per
Office 503, 5th Dy. No 617 50mg powder upto 10- Import
Floor, 6 Main Each vial contains:- dated 31- for injection 05-2017. Policy for
Gulberg, Jail Melphalan 12-2015 by M/s Aspen. Finished
Road, Lahore. Hydrochloride Rs.50,000/- Photocop Drugs

eq. to Melphalan y of
Manufactured (Anhydrous)…….50mg As per GMP
By SRO. valid
M/s. United (Multiple Myeloma upto 17-
Biotech (P) and Ovarian Cancer) 09-2017.
Limited, New Molecule
Bagbania,
Baddi-Nalagarh Manufacturer’s
Road, District- Specifications
Solan (Himachal 2 years
Pradesh)
174101, India.
100. M/s. Revive K-Styrn 15gm Sachet Form-5A Japan. Free sale Deferred
Health Care, Polystryene issued for
Office 503, 5th Each sachet contains:- Dy No.613 Sulphonate dated 26- confirmati
Floor, 6 Main Calcium Polystyrene 31-12-2015 Sachet 15gm. 02-2016. on
Gulberg, Jail Sulfonate………15gm Rs.50,000/- COPP whether
Road, Lahore. valid up formulatio
(Potassium Binder) to 10-05- n is
Manufactured 2017. already
by Manufacturer’s registered
M/s. United Specifications Leglalize or
Biotech (P) Ltd., 02 years d otherwise
Village photocop
Bagbania, y of
Baddi-Nalagarh GMP
Road, District- valid
Solan (H.P) upto 17-
174101, India. 09-2017
101. M/s. Revive Amphotin Lip-50 Form 5A

MHRA. Free sale Deferred
Health Care, Injection Abelcet issued as the
Office 503, 5th Dy No. 614 5mg/ml dated 26- product
Floor, 6 Main Each vial contains:- 31-12-2015 Amphotericin 02-2016. does not
Gulberg, Jail Amphotericin B Lipid Rs.50,000/- B lipid COPP fall in the
Road, Lahore. Complex…50mg complex(10ml valid priority
As per PRC , 20ml) upto 10- list.
M/s. United (Antifungal) Concen. For 5-2017 Moreover
Biotech (P) Ltd., infusion by Anti-
Village Manufacturer’s M/s Teva. Legalize fungal
Bagbania, Specifications d drugs are
Baddi-Nalagarh 2 years photocop not
Road, District- y of importable
Solan (Himachal GMP from India
Pradesh) valid as per

174101, India. upto 17- Import
09-2017. Policy
Order,
2016
102. M/s. Revive Vonaz 200 Injection Form 5A MHRA. Vfend Free sale Deferred
Health Care, 200mg powder issued as Anti-
Office 503, 5th Each ml contains:- Dy No. 615 for infusion by dated 26- fungal
Floor, 6 Main Voriconazole….200mg dated 31- Pfizer. 02-2016. drugs are
Gulberg, Jail 12-2015 COPP not
Road, Lahore. (Antifungal) Rs.50,000/- valid importable
upto 10- from India
M/s. United Manufacturer’s As per PRC 5-2017. as per
Biotech (P) Ltd., Specifications GMP Import
Village 2 years valid Policy
Bagbania, upto 17- Order,
Baddi-Nalagarh 09-2017. 2016.
Road, District-
Solan (Himachal
Pradesh)
174101, India.
103. M/s. Revive Colicraft 1,000,000 IU Form 5A MHRA. COPP Deferred
Health Care, powder for solution for Colomycin issued for
Office 503, 5th Injection Dy No. 619 1MIU by M/s dated 04-confirmati
Floor, 6 Main 31-12-2015 Forest. 05-2016. on
Gulberg, Jail Each vial contains:- Rs.50,000/- whether
Road, Lahore. Colistimethate Sodium Firm is formulatio
…1,000,000 I.U As per PRC GMP n is
Manufactured complian already
by (Antibiotic)/Polymyxin t as per registered
M/s. ) COPP. or
GENFARMA otherwise
LABORATORI USP Specifications
O, S.L. Site
address Avda. 03 years
De la
Constitucion,
198-199
Poligono
Industrial Monte
Boyal,
Casarrubios del
Monte 45950
(Toledo)
Espana, Spain.
Market
Authorization

Holder.
M/s G.E.S
Genericos
Espanoles
Laboratorio, S.A
Colquide,6-
Portal, Spain
104. M/s. Servier Implicor Film Coated Form 5A COPP Deferred
Research and Tablets (Photoco for the
Pharmaceuticals Each film coated tablet Dy no. 172 py) was submissio
Pakaistan contains:- dated 10- issued by n of
Private Limited, Metoprolol 02-2016 France following
65 Main Tartrate………….50mg Rs.100,000 on dated a. Valid
Boulevard Ivabradine…………… /- 18-09- legalized
Gulberg, ……….5mg 2015. COPP
Lahore. (Antianginal) GMP b.Stability
18 months photocop data as per
M/s. Les y conditions
Laboratoirie attached of zone IV
Industrie, 905, Stability A.
route de Saran data is c.
45520 Gidy, not as Approval
France. per status in
condition reference
s of Zone countries.
IV A
however
stress
stability
data
attached.
105. M/s. AJ Mirza Finpecia Film Coated Form 5A COPP Defered as
Pharma (Pvt) Tablets valid the
Ltd., 7-Ground Dy No.174 upto 16- product
Floor, Shafi Each film coated tablets dated 12- 10-2016. does not
Court, contains:- 02-2016 GMP fall in the
Merewether Finasteride Rs.100,000 complian priority
Road, Civil USP…………1mg /- t as per list.
Lines, Karachi. COPP.
M/s. Cipla Ltd, (Anti Androgenic) As per
S-103 to S-105, 36 months SRO
S-107 to S-112,
L-138, L-147,
L-147/1 to L-
147/3, L-147/A,
Verna Industrial

Estate, Verna,
Goa.
106. M/s. Genix Genitinib 100mg Hard Form 5A MHRA. COPP, Deferred
Pharma Gelatin Capsule Glivec 100mg GMP & for the
(Private) Dy. No 206 & 400mf f/c stability submissio
Limited, 44-45- Each capsule contains:- dated 04- tablet by M/s data not n of
B, Korangi Imatinib Mesilate 03-2016 Novartis. attached. following
Creek Road, eq. Rs.100,000 Form 5A a.Valid
Karachi-75190. / Imatinib………………. /- is Legalized
Manufactured .100mg incomple COPP
by :- te. b. Stability
M/s. NOBILUS (Philadelphia Finish data as per
ENT chromosome positive product conditions
Swarszewska chronic myeloid specifica of Zone
45, 01-821 leukemia) tions are IV A.
Warsaw, not c.
Poland. Shelf Life 2 years attached. Completio
Supplying (Vol. 1 of 3 ) n of Form
Agent: 5A.
M/s. Labosuan d. Finish
S.L. calle product
Einsten 8-28108 specificati
Alcobendas, ons.
Madrid, Spain.
107. M/s. Genix Genitinib 400mg Hard Form 5A MHRA. COPP, Deferred
Pharma Gelatin Capsule Glivec 100mg GMP & for the
(Private) Dy. No 313 & 400mg f/c stability submissio
Limited, 44-45- Each capsule contains:- dated 04- by M/s data not n of
B, Korangi Imatinib Mesilate 03-2016 Novartis. attached. following
Creek Road, eq. Rs.100,000 Form 5A a.Valid
Karachi-75190. / Imatinib………………. /- Local. Glivec is Legalized
Manufactured .400mg 100mg & incomple COPP
by :- 400mg by M/s te. b. Stability
M/s. NOBILUS (Philadelphia Novartis Finish data as per
ENT chromosome positive Pharma. product conditions
Swarszewska chronic myeloid specifica of Zone
45, 01-821 leukemia) tions are IV A.
Warsaw, not c.
Poland. attached. Completio
Supplying Shelf Life 2 years n of Form
Agent: 5A.
M/s. Labosuan d. Finish
S.L. calle product
Einsten 8-28108 specificati

Alcobendas, ons.
Madrid, Spain.
108. M/s. Genix Genoxaltin 50mg Form 5A MHRA. COPP Deferred
Pharma Powder for Infusion Oxaliplatin issued for the
(Private) Dy. 208 50mg & dated 19- clarificatio
Limited, 44-45- Each vial contains:- dated 100mg powder 03-2016 n of
B, Korangi Oxaliplatin………..50m 02-03-2016 for solution for COPP strength
Creek Road, g Rs.100,000 infusion by strength 5mg/ml on
Karachi-75190. / /- M/s Actavis. is COPP
Manufactured Treatment of mentione whereas
by: metastatic colorectal Not d as the firm
M/s. Samyang cancer) provided. 5mg/ml has
Genex Pack applied in
Corporation, sizes are powder
1688-3, Sinil- Shelf Life 3 years not form in
dong Daedeok- mentione Form 5A.
gu Daejeon 306- d on
220, Korea. COPP.
Analytical GMP
Testing & complian
Batch Release t as per
by: COPP.
M/s. Aq Vida Single
GmbH Kaiser- COPP
Wilhelm-Str.89 for 2
20355 Hamburg, products.
Germany.
Marketing
Authorization
Holder:
M/s. Labosuan
S.L. calle
Einsten 8-28208
Alcobendas,
Madrid, Spain.
109. M/s. Genix Genoxaltin 100mg Form 5A MHRA. COPP Deferred

Pharma Powder for Infusion Oxaliplatin issued for the
(Private) Dy. No 209 50mg & dated 19- clarificatio
Limited, 44-45- Each vial contains:- dated 02- 100mg powder 03-2016 n of
B, Korangi Oxaliplatin………..100 03-2016 for solution for COPP strength
Creek Road, mg Rs.100,000 infusion by strength 5mg/ml on
Karachi-75190. / /- M/s Actavis. is COPP
Manufactured Treatment of mentione whereas
by: metastatic colorectal d as the firm
M/s. Samyang cancer) 5mg/ml has

Genex Shelf Life 3 years GMP applied in
Corporation, complian powder
1688-3, Sinil- t as per form in
dong Daedeok- COPP. Form 5A.
gu Daejeon 306-
220, Korea.
Analytical
Testing &
Batch Release
by:
M/s. Aq Vida
GmbH Kaiser-
Wilhelm-Str.89
20355 Hamburg,
Germany.
Marketing
Authorization
Holder:
M/s. Labosuan
S.L. calle
Einsten 8-28208
Alcobendas,
Madrid, Spain.
110. M/s. Genome Zoledron Lyophilized Form 5A MHRA. Docume Approved
Pharma, Powder for Solution for Zoledronic nts are as per
House # 593-B, Infusion Dy. No 246 Acid 4mg/5ml not Import
Street # 10, dated 14- by M/s legalized Policy for
Chaklala Each vial contains:- 03-2016 Intrapharm. . Finished
Scheme III, Zoledronic Acid (as Rs.100,000 COPP Drugs
Rawalpindi. Zoledronic acid /- issued on
monohydrate)………… As per 31-07-
Manufactcured …………4mg SRO 2015 by
by M/s. Republic
"Belmedprepara (Prevention of skeletal of
ty" RUE, 30 related events(e.g Belarus.
Fabritsius Str. tumor induced GMP
220007 Minsk, hypercalcemia) in complian
Republic of adult patients with t as per
Belarus. advanced COPP.
malignancies involving GMP
bone). valid
upto 10-
Manufacturer’s 10-2017.
Specifications
02 years

111. M/s. Genome Gemcitabel Lyophilized Form 5A Docume Approved
Pharma, Powder for Solution for nts are as per
House # 593-B, Infusion Dy. No 237 not Import
Street # 10, R&I 14-03- legalized Policy for
Chaklala Each vial contains:- 2016 . Finished
Scheme III, Gemcitabine Rs.100,000 COPP Drugs.
Rawalpindi./ Hydrochloride /- issued on Firm has
Manufactcured …1000mg 31-07- provided
by M/s. 2015 by valid
"Belmedprepara (Advanced or met- AS per Republic legalized
ty" RUE, 30 static bladder cancer SRO of CoPP
Fabritsius Str. in combination with Belarus.
220007 Minsk, cisplatin, locally or GMP
Republic of meta-static complian
Belarus. adenocarcinoma of t as per
pancreas) COPP.
GMP
valid
USP Specifications upto 10-
02 years 10-2017.
112. M/s. Genome Gemcitabel Lyophilized Form 5A Docume Approved
House # 593-B, Infusion Dy. No. not Import
Street # 10, 236 dated legalized Policy for
Chaklala Each vial contains:- 14-03-2016 . Finished
Scheme III, Gemcitabine Rs.100,000 COPP Drugs.
Rawalpindi. Hydrochloride ..200mg / issued on Firm has
31-07- provided
Manufactcured (Advanced or met- 2015 by valid
by M/s. static bladder cancer As per Republic legalized
"Belmedprepara in combination with SRO of CoPP
ty" RUE, 30 cisplatin, locally or Belarus.
Fabritsius Str. meta-static GMP
220007 Minsk, adenocarcinoma of complian
Republic of pancreas) t as per
Belarus. COPP.
USP Specifications GMP
valid
02 years upto 10-
10-2017.
113. M/s. Genome Methobel Lyophilized Form 5A Docume Approved
House # 593-B, Injection Dy. 238 not Import
Street # 10, R&I dated legalized Policy for

Chaklala Each vial contains:- 14-03-2016 . Finished
Scheme III, Methotrexate as Rs.100,000 COPP Drugs.
Rawalpindi./ sodium……..50mg / issued on Firm has
Manufactcured 31-07- provided
by M/s. (Antineoplastic drug) As per PRC 2015 by valid
"Belmedprepara Republic legalized
ty" RUE, 30 USP Specifications of CoPP
Fabritsius Str. 02 years Belarus.
220007 Minsk, GMP
Republic of complian
Belarus. t as per
COPP.
GMP
valid
upto 10-
10-2017.
114. M/s. Genome Anastrozole-Belmed Form 5A MHRA. Docume Approved
Pharma, Film Coated Tablets Anastrozole nts are as per
House # 593-B, Dy. No 239 1mg f/c by not import
Street # 10, Each film coated tablets dated 14- M/s consilent. legalized
Policy for
Chaklala contains:- 03-2016 . Finished
Scheme III, Anastrozole………….1 Rs.100,000 Local. COPP Drugs, as
Rawalpindi. mg / Anastrozole issued on
firm has
Manufactcured 1mg by M/s 09-02- provided
by M/s. (Treatment of As per PRC Pfizer 2015 by valid
"Belmedprepara harmone recpotor Republiclegalized
ty" RUE, 30 positive advanced of CoPPprovi
Fabritsius Str. breast cancer in post Belarus.ded.
220007 Minsk, menopausal women GMP Panel shall
Republic of ) complianconfirm
Belarus. t as perthe
Manufacturer’s COPP. anticancer
Specifications GMP facility for
valid the
02 years upto 10-manufactu
10-2017.ring of the
drug at the
time of
foreign
inspection
115. M/s. LDS (Pvt) Temozol 20 Capsules Form 5A MHRA. COPP Approved
Ltd., Dy.No. 314 Temodal 5mg, valid up as per
57/1 A Satellite Each hard gelatin R&Idated 20mg, 100mg, to 2-8- import
Town, capsule contains:- 22-04-2016 140mg, 180mg 2016. Policy for
Rawalpindi- Temozolomide……… Rs.50, & 250mg by Finished
Pakistan. ……20mg 000/- & M/s Merck GMP Drugs

Manufactured 50,000 18- valid
by:- (For newly diagnosed 03-2016. Local. upto 02-
M/s. Glioblastoma Temoside 08-2016.
Khandelwal multiforme 20mg, 100mg
Laboratories concomitantly with & 250mg by
Pvt. Ltd., Plot radiotherapy) M/s AJ. Mirza.
B-1, Wagle
Industrial Estate, Manufacture’s
Thane-400 604, Specifications
Maharashtra,
India. 24 months
116. M/s. LDS (Pvt) Temozol 100 Capsules Form 5A MHRA. COPP Approved
Ltd., Dy No.315 Temodal 5mg, valid as per
57/1 A Satellite Each hard gelatin R&I 20mg, 100mg, upto 02- import
Town, capsule contains:- 22-04-2016 140mg, 180mg 08-2016. Policy for
Rawalpindi- Temozolomide……… Rs.50,000/- & 250mg by Finished
Pakistan. ……100mg & M/s Merck GMP Drugs
Rs.50,000 valid
Manufactured (For newly diagnosed dated 18- Local. upto 02-
by:- Glioblastoma 03-2016. Temoside 08-2016.
M/s. multiforme 20mg, 100mg
Khandelwal concomitantly with & 250mg by
Laboratories radiotherapy) M/s AJ. Mirza.
Pvt. Ltd., Plot
B-1, Wagle Manufacturer’s
Industrial Estate, specifications.
Thane-400 604,
Maharashtra, 24 months
India.
117. M/s. LDS (Pvt) Doxorubin 50 Form 5A MHRA. COPP Deferred

Ltd., Hydrochloride for Dy. 311 Doxorubicin validfor the
57/1 A Satellite injection Dated 22- 50mg by M/s upto 02-
clarificatio
Town, 04-2016 Teva 08-2016
n of the
Rawalpindi- Each vial contains:- Rs.50,000/- . following
Pakistan. / Doxorubicin &Rs.50,00 Local. Adrim a.Fresh
Manufactured Hydrochloride 0 dated 18- by M/s Atco GMP Sole
by:- USP……………….50 03-2016. valid agency
M/s. mg upto 02- agreement
Khandelwal Lactose USP………q.s. Rs.1625/Vi 08-2016 as
Laboratories al . clarificatio
Pvt. Ltd., Plot (Small cell lung n of the
B-1, Wagle cancer, Breast cancer, status of
Industrial Estate, bladder carcinoma, registratio
Thane-400 604, Hodgkin’s disease) n letter as

India. the
USP Specifications products
are already
30 months approved
in 227th
meeting
with M/s
Scarlet.
118. M/s. LDS (Pvt) Epichlor 10 Powder for Form-5A MHRA. COPP Approved
Ltd., injection (Lyophilized) Epirubicine valid up as per
57/1 A Satellite Each vial contains:- Dy No. 404 10mg & 50mg to 2-8- import
Town, Epirubicin R&I-dated powder for 2016 Policy for
Rawalpindi- Hydrochloride 18.03.2016 solution for GMP Finished
Pakistan. / BP…………10mg injection by valid Drugs
Manufactured Rs50000/- M/s Actavis upto 02-
by:- (Used in Neoplastic dated 18- 08-2016.
M/s. conditions breast, 03-2016 Local. .
Khandelwal ovarian, Gastric, lung Balance Anthracin
Laboratories and Colorectal Rs50000/- 50mg & 10mg
Pvt. Ltd., Plot carcinomas, Malignant dated 22- by M/s Atco
B-1, Wagle lymphomas) 04-2016
Industrial Estate,
Thane-400 604, 36 months
India.
119. M/s. LDS (Pvt) Epichlor 50 Powder for Form 5A MHRA. COPP Approved
Ltd., injection (Lyophilized) Epirubicine valid as per
57/1 A Satellite Dy. No 313 10mg & 50mg upto 02- import
Town, Each vial contains:- R&I dated powder for 08-2016. Policy for
Rawalpindi- Epirubicin 22-04-2016 solution for GMP Finished
Pakistan. / Hydrochloride Rs.50,000/- injection by valid Drugs
Manufactured BP…………50mg & M/s Actavis upto 02-
by:- Rs.50,000 08-2016.
M/s. (Used in Neoplastic dated 18- Local.
Khandelwal conditions breast, 03-2016. Anthracin
Laboratories ovarian, Gastric, lung 50mg & 10mg
Pvt. Ltd., Plot and Colorectal Rs. 2540/- by M/s Atco
B-1, Wagle carcinomas, Malignant per vial
Industrial Estate, lymphomas)
Thane-400 604,
India. Manufacture’s
Specifications
36 months
120. M/s. LDS (Pvt) Doxorubin 10 Form 5A MHRA. Photocop Deferred

Ltd., Hydrochloride for Dy. 312 Doxorubicin y of for the
57/1 A Satellite injection Dated 22- 10mg by M/s COPP clarificatio
Town, 04-2016 Teva valid n of the
Rawalpindi- Each vial contains:- Rs.50,000/- upto 02- following
Pakistan. Doxorubicin &Rs.50,00 Local. Adrim 08-2016. a.Fresh
Manufactured Hydrochloride 0 dated 18- by M/s Atco Photocop Sole
by:- USP………….10mg 03-2016. y of agency
M/s. Lactose USP…q.s. GMP agreement
Khandelwal Rs.490/Via valid as
Laboratories (Small cell lung l upto 02- clarificatio
Pvt. Ltd., Plot cancer, Breast cancer, 08-2016. n of the
B-1, Wagle bladder carcinoma, status of
Industrial Estate, Hodgkin’s disease) registratio
Thane-400 604, n letter as
India. the
USP Specifications products
are already
30 months approved
in 227th
meeting
with M/s
Scarlet.
121. M/s. LDS (Pvt) Oncomide 1000 Powder Form 5A MHRA. Photocop Deferred
Ltd., for injection Dy. No 316 Cyclophospha y of for the
57/1 A Satellite dated 22- mide 1000mg COPP clarificatio
Town, Each vial contains:- 04-2016 by M/s Baxtervalid n of the
Rawalpindi- Cyclophosphamide Rs.50,000/- upto 02- following
Pakistan. / anhydrous 1.07gm & 18-03- Local. Zyman 08-2016 a.Fresh
Manufactured Equivalent to 2016 by M/s Al- Photocop Sole
by:- Cyclophosphamide…..1 Rs.50,000. Habib y of agency
M/s. .00gm GMP agreement
Khandelwal Rs.230/vial valid as
Laboratories (Chronic Lymphocytic upto 02- clarificatio
Pvt. Ltd., Plot Leukaemis &Acute 08-2016. n of the
B-1, Wagle Lymphocytic status of
Industrial Estate, Leukaemis) registratio
Thane-400 604, n letter as
India. USP Specifications the
products
36 months are already
approved
in 227th
meeting
with M/s
Scarlet.

122. M/s. LDS (Pvt) Bortemib 3.5 Powder Form 5A MHRA. COPP Deferred
Ltd., for Injection Dy. NO Velcade 3.5gm valid for the
57/1 A Satellite (Lyophilized) 407 dated powder for upto 02- clarificatio
Town, 18-03-2016 solution for 08-2016 n as
Rawalpindi- Each vial contains:- Rs.50,000/- injection. . product is
Pakistan. Bortezomib…………3. GMP approved
Manufactured 5mg Rs.27500/v valid by
by:- ial upto 02- reference
M/s. (Lumphocutic 08-2016 regulatory
Khandelwal leukemia, indolent . authorities
Laboratories non-Hodgkin’s Internati as
Pvt. Ltd., Plot lymphoma, multiple onaly the mannitol
B-1, Wagle myeloma) product boronic
Industrial Estate, is present ester form.
Thane-400 604, Manufacturer’s as
India. Specifications mannitol
boronic
24 months ester.
123. M/s. LDS (Pvt) Unilistin Colistimethate Form 5-A Antibioti Deferred
Ltd., Sodium for Injection cs are as the
57/1 A Satellite BP 1 Million IU Dy.No.318 not product is
Town, Each vial contains:- 25-04-2016 importab a me too
Rawalpindi- Colistimethate Sodium Rs.50,000/- le from not a new
Pakistan./ BP……1,000,000 IU India. drug.
Manufactured Sole
by:- agency
M/s. United agreeme
Biotech (P) Ltd., nt is not
Bagbania, provided.
Baddi-Nalagarh FSC
Road, District issued
Solan, Himachal dated 26-
Pradash-174 1-2016.
101, India. Stability
data as
per zone-
IV is not
provided
Finish
product
specifica
tions are
not

provided.
124. M/s. Genix Leeza 2.5mg Tablets Form 5A MHRA. Femra Fee Rs Approved
Pharma 2.5mg f/c 100,000 as per
(Private) Each film coated tablets Dy No. tablet by M/s is a Import
Limited, 44-45- contains:- R&I Dated Novartis. photocop Policy for
B, Korangi Letrozole………….2.5 19-09-2016 y. Finished
Creek Road, mg Rs.100,000 Local. Femra Dossier Drugs.
Karachi-75190. / /- 2.5mg by M/s is a Panel shall
Manufactured (Adjuant treatment of Novartis. duplicate confirm
by :- post-menopausal . the
M/s. Jiangsu women with harmone COPP anticancer
Hengrui recpotor positive valid facility for
Medicine Co. invasive early breast upto 18- the
Ltd., UNo.38 cancer) 02-2018. manufactu
Huanghe Road, GMP ring of the
Lianyungang USP Specifications. complian drug at the
Economic and 02 years t as per time of
Technological COPP. foreign
Development GMP inspection.
Zone, Jiangsu, valid Chairman
China. upto 18- Registrati
02-2018. Board is
authorized
for the
issuance
of
Registratio
n letter
after
verificatio
n of fee
from
Budget &
Accounts.
125. M/s. Graton Zoltran Injection Form 5A MHRA. Free Approved

Pharma, 4mg/5ml Zoledronic sales as per
Suit No. 102, Dy. No 348 Acid 4mg/5ml certificat import
The Plaza, Each vial contains:- Dated 20- by M/s e issued Policy for
Clifton 2 Zoledronic 04-2016 Intrapharm. on 27- Finished
Talwar, Karachi. acid……..4mg Rs.100,000 01-2016. Drugs
Manufactured / GMP
by (Prevention of skeletal valid
M/s. Yangtze related events(e.g As per upto 13-
River tumor induced SRO 03-2018

Pharmaceutical hypercalcemia) in
Group Sichuan adult patients with
Hairong advanced
Pharmaceutical malignancies involving
Co. LTd., bone).
Dujiangyan
High Tech Manufacturer’s
Development Specifications
Zone, Sichuan, 2 years
China.
126. M/s. Graton Grataxel 100mg/16.7ml Form 5A MHRA. COPP Approved

Pharma, injection Paclitaxel 18-04-
Suit No. 102, Dy. No. 6mg/ml Conc. 2016.
The Plaza, Each vial contains:- 1026 Dated for solution for
Clifton 2 Paclitaxel………….100 18-04-2016 infusion by
Talwar, Karachi. mg Rs.100,000 M/s Medac
Manufactured / (5ml, 16.7ml,
by (Monotherapy for 50ml &
M/s. Yangtze meta-static breast 100ml).
River cancer. In As per
Pharmaceutical combination with SRO Local.
Group Co. Ltd Gemcitabin for meta- Panataxel
1 South , static adenocarcinoma 100mg,
Yangtze River of pancreas) 150mg, 300mg
Road, Taizhou, & 30mg by
Jiangsu, 225321 USP Specifications M/s
China. Ferozsons.
03 years
127. M/s. Roche Esbriet Hard Capsules Form 5-A FDA. Esbriet Orignal Deferred
Pakistan Each hard capsules Dy No.350 by M/s legalized for the
Limited, contains:- 29-04-2016 Genetech. COPP is submissio
37-C, Bock-6, Pirfenidone…..267mg Rs.50,000/- not n of
P.E.C.H.S. provided. following
Karachi./ (Anti-fibrotic agent) a.valid
M/s. Made for legalized
Roche New Molecule COPP
Registration b.Stability
Limited, 4 years data as per
Welwyn Garden conditions
City, UK by F. of Zone
Hoffmann-La IV A.
Roche Ltd.,
Basel,
Switzerland
manufacturing

Site Catalent
Pharma
Solutions LLC,
Winchester
(KY), USA.
128. M/s. Revive Octreotide 50mcg Form 5A FDA. Free sale Approved
Health Care, Injection Sandostatin issued as per
Office 503, 5th Dy No. 357 50mcg/ml by dated 26- import
Floor, 6 Main Each vial of ampoule dated M/s Novartis. 02-2016. Policy for
Gulberg, Jail contains:- 29-04-2016 COPP Finished
Road, Lahore. Octreotide acetate Rs.50,000/- Local. valid Drugs
equivalent to 0.05mg & 50,000 Sandostatin upto 10-
Manufactured milligrams of octreotide dated 24- 0.05mg/ml & 5-2017.
by ……50mcg 06-2016. 0.1mg/ml by GMP
M/s. United M/s Novartis. valid
Biotech (P) (Acromegaly/Carcinoi As per upto 17-
Limited, d Tumors/Vasoactive SRO 09-2017.
Bagbani, Baddi, Intestinal tumors)
Nalagarh Road,
District, Solan,
India. Manufacturer’s
Specifications
03 years
129. M/s. Revive Octreotide 100mcg Form 5A FDA. Free sale Approved
Health Care, Injection Sandostatin issued as per
Office 503, 5th Dy. 356 100mcg/ml by dated 26- import
Floor, 6 Main Each vial of ampoule Dated 29- M/s Novartis. 02-2016. Policy for
Gulberg, Jailcontains:- 04-2016 COPP Finished
Road, Lahore. Octreotide acetate Rs.50,000/- Local. valid Drugs
equivalent to octreotide & 50,000 Sandostatin upto 10-
Manufactured …100mcg dated 24- 0.05mg/ml & 5-2017.
by 06-2016. 0.1mg/ml by GMP
M/s. United (Acromegaly/Carcinoi M/s Novartis. valid
Biotech (P) d Tumors/Vasoactive upto 17-
Limited, Intestinal tumors) As per 09-2017
Bagbani, Baddi, SRO.
Nalagarh Road, Manufacturer’s
District, Solan, Specifications
India. 03 years
130. M/s. Revive Vasmed Injection Form-5 A MHRA. Free sale Approved
Health Care, Vasopressin certificat as per
Office 503, 5th Each ampoule Dy No 354. 20IU/ml by e issued import

Floor, 6 Main contains:- 29-04-2016 M/s par on 26- Policy for
Gulberg, Jail Synthetic Rs.50,000/- Sterile. 02-2016. Finished
Road, Lahore. Vasopressin….20 IU COPP Drugs
As per PRC valid
Manufactured (Synthetic Hormone) upto10-
by New Molecule 5-2017.
M/s. United GMP
Biotech (P) Ltd., USP specifications valid
Village upto 17-
Bagbania, 03 yearts 09-2017.
Baddi-Nalagarh
Road, District-
Solan (H.P)
174101, India.
131. M/s. Revive Vinotec 50mg Injection Form 5A MHRA. Free sale Approved
Health Care, Navelbine issued as per
Office 503, 5th Each vial of 5ml Dy. No 359 10mg/ml dated 26- import
Floor, 6 Main contains:- Dated 29- (5ml) by M/s 11-2015. Policy for
Gulberg, Jail Vinorelbine as Tartrate 04-2016 Pierre. COPP Finished
Road, Lahore. eq. to Rs.50,000/- valid Drugs
Vinorelbine…….50mg & 50,000 Local. Vilne upto 10-
Manufactured dated 24- by M/s Ghani 5-2017.
by (Stage III & IV small 06-2016. Brothers GMP
M/s. United cell lung cancer, valid
Biotech (P) Ltd., Advance Breast cancer As per upto 17-
Village for stage III & IV) PRC. 09-2017.
Bagbania,
Baddi-Nalagarh USP Specifications
Road, District-
Solan (H.P) 03 years
174101, India.
132. M/s. Revive Colicraft 2,000,000 IU Form 5A MHRA. COPP Deferred
Health Care, Lypholized powder for Colomycin was for
Office No.503, solution for Injection Dy No.358 1MIU & 2 issued by confirmati
5th Floor, 6 R&I dated MIU by M/s Spain on on
Main Gulberg, Each vial contains:- 29-04-2016 Forest. dated 04- whether
Jail Road, Colistimethate Sodium Rs.50,000/- 05-2016. formulatio
Lahore. …2,000,000 I.U GMP n is me too
As per complian or
M/s. (Antibiotic)/Polymyxin PRC. t as per otherwise
GENFARMA ) COPP
LABORATORI dated 04-
O, S.L. Site USP Specifications 05-2016.
address Avda.
De la 03 years
Constitucion,

198-199,
Poligono
Industrial Monte
Boyal,
Casarrubios del
Monte 45950
(Toledo)
Espana, Spain.
133. M/s. Amgomed, Irinotecan medac Form 5A MHRA. COPP Approved

Office # 5, 1st 100mg/5ml Injection Campto issued as per
Floor Rose 1, Dy. No 362 20mg/ml dated 18- import
Plaza I-8 Each vial contains:- Dated 29- (100mg/5ml) 04-2016. Policy for
Markaz, Irinotecan……..100mg 04-2016 Conc. For GMP Finished
Islamabad. Rs.100,000 solution for complian Drugs
(Advanced Colorectal /- infusion by t as per
Market cancer) M/s Pfizer. COPP.
authorization As per
holder SRO/5ml Local. CPT-11
M/s. MEDAC, Manufacturer’s injection by
Gesellschaft fur Specifications M/s Medinet.
klinische
Spezialpraparate 03 years
mbH,
Fehlandtstrasse
3 20354
Hamburg,
Germany.
Labelling,
Secondary
Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec

pharma
produktin
GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
134. M/s. Amgomed, LipAd Injection Form 5A MHRA. Free sale Approved
Office # 5, 1st Caelyx issued as per
Floor Rose 1, Each vial contains:- Dy. No 362 2mg/ml conc. dated 12- import
Plaza I-8 20mg Doxorubicin dated 29- For solution 04-2016. Policy for
Markaz, Hydrochloride in 10ml 04-2016 for infusion. Finished
Islamabad. pegylated liposomal Rs.100,000 GMP of Drugs
/- Local. the
Manufactured (Alone for meta-static Doxopeg by manufact
by breast cancer, As per M/s uring
M/s. CSPC advanced ovarian SRO. Ferozsons. place not
Ouyi cancer. In provided.
Pharmaceutical combination with
Co. Ltd., No.88, Bortezomide for
Yangzi Road, treatment of
Shijiazhuang progressive multiple
City of China. myeloma.)
Manufacturer’s
Specifications
24 months
135. M/s. Amgomed, Temomedac 100mg Form 5A
MHRA. COPP Approved
Office # 5, 1st Capsule Temodal 5mg, issued as per
Floor Rose 1, Dy. No 363 20mg, 100mg, dated 18- import
Plaza I-8 Each capsule contains:-
Dated 29- 140mg, 180mg 04-2016. Policy for
Markaz, Temozolomide………1 04-2016 & 250mg by GMP Finished
Islamabad. 00mg Rs.100,000 M/s Merck complian Drugs
/- t as per
Market (For newly diagnosed Local. COPP.
authorization Glioblastoma As per Temoside
holder multiforme SRO. 20mg, 100mg
M/s. MEDAC, concomitantly with & 250mg by
Gesellschaft fur radiotherapy) M/s AJ. Mirza.
klinische
Spezialpraparate Manufacturer’s
mbH, Specifications
Fehlandtstrasse 03 years
3 20354

Hamburg,
Germany.
Labelling,
Secondary
Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec
pharma
produktin
GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
136. M/s. Amgomed, Paclitaxel medac Form 5 A MHRA. COPP Approved

Office # 5, 1st 100mg/16.7ml Injection Paclitaxel issued as per
Floor Rose 1, Dy. NO 6mg/ml Conc. dated 18- import
Plaza I-8 Each vial contains:- 364 dated for solution for 04-2016. Policy for
Markaz, Paclitaxel…………100 29-04-2016 infusion by GMP Finished
Islamabad. mg Rs.100,000 M/s Medac complian Drugs
Market /- (5ml, 16.7ml, t as per
authorization (Monotherapy for 50ml & COPP.
holder meta-static breast As per 100ml). Single
M/s. MEDAC, cancer. In SRO/16.7m COPP
Gesellschaft fur combination with l. Local. for two
klinische Gemcitabin for meta- Panataxel products
Spezialpraparate static adenocarcinoma 100mg, .
mbH, of pancreas) 150mg, 300mg
Fehlandtstrasse ) & 30mg by
3 20354 M/s
Hamburg, USP Specifications Ferozsons.
Germany.

Labelling, 03 years
Secondary
Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec
pharma
produktin
GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
137. M/s. Amgomed, Paclitaxel medac Form 5A MHRA. COPP Approved

Office # 5, 1st 300mg/50ml Injection Paclitaxel issued as per
Floor Rose 1, Dy.363 6mg/ml Conc. dated 18- import
Plaza I-8 Each vial contains:- dated 29- for solution for 04-2016. Policy for
Markaz, Paclitaxel…………300 04-2016 infusion by GMP Finished
Islamabad. mg Rs.100,000 M/s Medac complian Drugs
Market /- (5ml, 16.7ml, t as per
authorization (Monotherapy for 50ml & COPP.
holder meta-static breast As per 100ml). .
M/s. MEDAC, cancer. In SRO/50ml.
Gesellschaft fur combination with Local.
klinische Gemcitabin for meta- Panataxel
Spezialpraparate static adenocarcinoma 100mg,
mbH, of pancreas) 150mg, 300mg
Fehlandtstrasse & 30mg by
3 20354 M/s
Hamburg, USP Specifications Ferozsons.
Germany.
Labelling, 03 years
Secondary

Packaging,
Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec
pharma
produktin
GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
138. M/s. Amgomed, Topotecan medac 4mg Form 5A FDA. COPP Approved
Office # 5, 1st Injection Topotecan 1, 3 issued as per
Floor Rose 1, Dy. No 360 & 4mg dated 18- import
Plaza I-8 Each vial contains:- Dated 29- solution for 04-2016. Policy for
Markaz, Topotecan as 04-2016 injection by GMP Finished
Islamabad. Hydrochloride……..4m Rs.100,000 M/s Sandoz. complian Drugs
g /- t as per
Market Local. COPP.
authorization (Small cell Lung As per Hycamtin by
holder Cancer treatment) SRO. M/s GSK
M/s. MEDAC,
Gesellschaft fur Manufacturer’s
klinische Specifications
Spezialpraparate 03 years
mbH,
Fehlandtstrasse
3 20354
Hamburg,
Germany.
Labelling,
Secondary
Packaging,

Quality
Control/testing
& Batch release
by
M/s. MEDAC,
Gesellschaft fur
klinische
Spezialpraparate
mbH,
Theaterstr, 6,
22880 Wedel,
Germany.
Manufactured
by
M/s Oncotec
pharma
produktin
GmbH, Am
Pharmapark,
06861 Dessau-
Rosslau,
Germany.
139. M/s. Amgomed, Ocladra 2mg/ml Form 5A MHRA. Litak COPP Approved
Office # 5, 1st injection (5ml vial) 2mg/ml issued on as per
Floor Rose 1, Dy. No 361 Solution for 22-01- import
Plaza I-8 Each vial contains:- Dated 29- injection 2016 Policy for
Markaz, Cladribine 04-2016 5ml/10mg by . Finished
Islamabad. Hydrochloride……..10 Rs.50,000/- M/s Lipomed. GMP Drugs
mg complian
Manufactured As per t as per
by (Treatment of Hairy PRC. COPP.
M/s. Mustafa cell Leukaemia)
Nevzat (MN),
Ilac San. Ve Tic. Manufacturer’s
A.S. Specifications
Cobancesme 03 years
Mah. Sanyi Cad.
No.13
Yenibosna/Istan
bul, Turkey.
140. M/s. Servier VIACORAM 3.5/2.5 Form 5-A Original Deferred

Research and Tablet Dy No. 371 legalized for the
Pharmaceuticals Each tablet contains:- 05-05-2016 COPP is submissio
Pakaistan Perindopril Rs.50,000/- not n of

Private Limited, Arginine………..3.5mg provided following
65 Main Amlodipine…………… Valid
Boulevard ……2.5mg legalized
Gulberg, (ACE inhibitors and COPP/
Lahore. / calcium channel GMP
M/s. Servier blockers) certificate
Deutschland & stability
GmbH New formulation data as per
Elsenheimerster 02 years conditions
80687 Munich, of Zone
Germany. IV A.
141. M/s. Merixil Lutrate 3month Depot Form 5A MHRA. COPP Approved
Pharma, (22.5mg) Injection Lutrate issued on as per
Office # 28, Dy. No. 22.5mg & 12-04- import
Second Floor, Each vial contains: 387 Dated 3.75mg 2016. Policy for
Rose Plaza, I-8 Leuprorelin acetate 04-05-2016 powder and Finished
Markaz, powder for prolonged Rs.100,000 solvent for GMP Drugs
Islamabad. release suspension for /- prolonged complian
injection….…22.5 mg release t as per
Manufactured suspension for COPP.
by (Palliative treatmentof As Per injection.
M/s. GP locally advanced & SRO/Kit GMP
Pharma, metastatic prostate (New issued
Polígono cancer) The molecule) dated 29-
Industrial Els commercial 10-2014
Vinyets -Els kit includes
Fogars, Sector 2. Manufacturer’s i.Glass Vial
Carretera Specifications. of
Comarcal C244, Leuprorelin
Km, 22 08777 Shelf life : 36months ii.Prefilled
Sant Quintí De glass
Mediona syringe 2ml
Barcelona, containing
Spain. solvent.
iii.Polycarb
onate
HDPE
Adaptor
system
with
syringe
with
needle.
142. M/s. Merixil Sterile Solvent For Form 5A MHRA. COPP Approved
Pharma, Lutrate Depot 3 month Dy. No 385 Lutrate issued on as per

Office # 28, Depot (22.5mg) Dated 04- 22.5mg & 12-04- import
Second Floor, 05-2016 3.75mg 2016. Policy for
Rose Plaza, I-8 Each pre filled syringe Rs.100,000 powder and (Same Finished
Markaz, 2ml contains:- /- solvent for COPP Drugs
Islamabad. prolonged for
Manufactured 0.8% mannitol solution release powder
by in water for injection. Free of suspension for and
M/s. GP Cost along injection. solvent)
Pharma, For reconstitution with For
Polígon purpose Lutrate
Industrial Els Manufacturer’s Depot 3 GMP
Vinyets -Els Specifications month issued
Fogars, Sector 2. Depot dated 29-
Carretera Shelf life: 36 months (22.5mg) 10-2014
Comarcal C244,
Km, 22 08777
Sant Quintí De
Mediona
Barcelona,
Spain.
143. M/s. Merixil Lutrate 1month Depot Form 5A MHRA. COPP Approved
Pharma, (3.75mg) Injection Lutrate issued as per
Office # 28, Dy. No 139 22.5mg & dated 12- import
Second Floor, Each vial contains: Datedm 04- 3.75mg 04-2016. Policy for
Rose Plaza, I-8 Leuprorelin acetate 05-2016 powder and (Original Finished
Markaz, powder for prolonged Rs.100,000 solvent for Embassy Drugs
Islamabad. release suspension for /- prolonged attested)
Manufactured injection….…3.75 mg release
by As per suspension for GMP
M/s. GP (Palliative treatmentof SRO/Kit injection. complian
Pharma, locally advanced & t as per
Polígon metastatic prostate The Local. COPP.
Industrial Els cancer) commercial Lectrum
Vinyets -Els kit includes 3.75mg by Embassy
Fogars, Sector 2. i.Glass Vial M/s Sandoz attested
Carretera Manufacturer’s of with solvent GMP
Comarcal C244, Specifications Leuprorelin issued
Km, 22 08777 ii.Prefilled dated 29-
Sant Quintí De Shelf life : 36months glass 10-2014
Mediona syringe 2ml
Barcelona, containing
Spain. solvent.
iii.Polycarb
onate

HDPE
Adaptor
system
with
syringe
with
needle..
144. M/s. Merixil Sterile Solvent For Form 5 A MHRA. Same Rejected
Pharma, Lutrate Depot 1 month Lutrate applicati as already
Office # 28, Depot (3.75mg) Dy. No 386 22.5mg & on approved
Second Floor, dated 04- 3.75mg applied at
Rose Plaza, I-8 Each pre filled syringe 05-2016 powder and for S.No.142
Markaz, 2ml contains: Rs.100,000 solvent for Lutrate
Islamabad. / 0.8% mannitol solution /- prolonged Depot 3
Manufactured in water for injection. release month
by suspension for Depot
M/s. GP For reconstitution Free of injection. (22.5mg)
Pharma, purpose Cost COPP
Polígon Local. issued
Industrial Els Manufacturer’s Lectrum dated 12-
Vinyets -Els Specifications 3.75mg by 04-2016.
Fogars, Sector 2. M/s Sandoz
Carretera Shelf life: 36 months with solvent GMP
Comarcal C244, complian
Km, 22 08777 t as per
Sant Quintí De COPP.
Mediona
Barcelona, GMP
Spain. issued
dated 29-
10-2014.
145. M/s. Revive Amphotin 50mg Form-5-A MHRA. Free sale Defered as
Health Care, Injection (Lyophilized) Fungizone issued the
Office No.503, Dy No.374 50mg powder dated 26- product
5th Floor, 6 Each vial contains:- dated 04- for solution by 02-2016. does not
Main Gulberg, Amphotericin B 05-2016 M/s E.R COPP fall in the
Jail Road, (Lyophilized)……….50 Rs.50,000/- Squibb. valid priority
Lahore. mg & upto list.
Rs.50,000 Local. GMP Moreover
M/s. United (Anti-fungal) dated 24- Medinet valid Anti-
Biotech (P) 06-2016. upto 17- fungal
Limited, Manufacturer’s 09-2017. drugs are
Bagbani, Baddi, Specifications As per not
Nalagarh Road, SRO importable
District, Solan, 02 years from India
India. as per

Import
Policy
Order,
2016
146. M/s. Revive Zimta 4mg/5ml Conc. Form 5A MHRA. COPP Approved
Health Care, for solution for Zoledronic issued as per
Office No.503, Injection Dy. No 376 Acid 4mg/5ml dated 04- import
5th Floor, 6 Dated 04- Conc. for 05-2016. Policy for
Main Gulberg, Each vial contains:- 05-2016 solution for GMP Finished
Jail Road, Zoledronic Rs.50,000/- Injection by complian Drugs
Lahore. Acid………….4mg & 50,000 M/s t as per
dated 24- Intrapharm. COPP.
Manufactured (Prevention of skeletal 06-2016.
By related events (e.g Local. Zometa
M/s. Alfa tumor induced by M/s
Wassermann hypercalcemia) in Novartis
S.p.A VIA adult patients with
Enrico Fermi, 1- advanced
65020 Alanno malignancies involving
(PE), Italy bone).
Final Product
release by Manufacturer’s
M/s Biomendi, Specifications
S.A. Poligono
Industrial de 02 years
Bernedo, s/n,
Bernedo, 01118
Alava, Spain.
147. M/s. Servier Triveram 20/5/5 Tablets Form 5-A Original Deferred
Research and Each film coated tablets legalized for the
Pharmaceuticals contains:- Dy. No.382 COPP / submissio
Pakaistan Atorvastatin………… 05-05-2016 GMP is n of
Private Limited, ……20mg Rs.50,000/- not following
65 Main Perindopril provided. a.Approva
Boulevard Arginine………5mg l status by
Gulberg, Amlodipine…………… reference
Lahore. …..5mg regulatory
M/s. Les authorities
Laboratoirie (Statin/ACE b.valid
Industrie, 905, Inhibitors/Calcium legalized
route de Saran Antagonist) COPP
45520 Gidy, New formulation c.Stability
France. data as per
02 years conditions
of Zone

IV A.
148. M/s. Servier Triveram 20/10/5 Form 5-A Original Deferred

Research and Tablets legalized for the
Pharmaceuticals Each film coated tablets Dy. No.385 COPP is submissio
Pakaistan contains:- 05-05-2016 not n of
Private Limited, Atorvastatin………… Rs.50,000/- provided. following
65 Main ……20mg a.Approva
Boulevard Perindopril l status by
Gulberg, Arginine………10mg reference
Lahore./ Amlodipine…………… regulatory
M/s. Les …..5mg authorities
Laboratoirie b.valid
Industrie, 905, (Statin/ACE legalized
route de Saran Inhibitors/Calcium COPP
45520 Gidy, Antagonist) c.Stability
France. data as per
New formulation conditions
of Zone
02 years IV A.
149. M/s. Servier Triveram 10/5/5 Tablets Form 5-A Original Deferred
Research and Each film coated tablets legalized for the
Pharmaceuticals contains:- Dy No.384 COPP is submissio
Pakaistan Atorvastatin………… 05-05-2016 not n of
Private Limited, ……10mg Rs.50,000/- provided. following
65 Main Perindopril a.Approva
Boulevard Arginine………5mg l status by
Gulberg, Amlodipine…………… reference
Lahore./ …..5mg regulatory
M/s. Les authorities
Laboratoirie (Statin/ACE b.valid
Industrie, 905, Inhibitors/Calcium legalized
route de Saran Antagonist) COPP
45520 Gidy, c.Stability
France. New formulation data as per
conditions
02 years of Zone
IV A.
Research and tablets legalized for the
Pharmaceuticals Each film coated tablets Dy No.386 COPP is submissio

France. data as per
of Zone
02 years IV A.
Research and tablets legalized for the
Pharmaceuticals Each film coated tablets Dy No.383 COPP is submissio
France. data as per
of Zone
02 years IV A.
152. M/s. Servier Viacoram 7/5 Tablets Form 5A Original Deferred
Research and Each tablets contains:- Legalize for the
Pharmaceuticals Perindopril Dy No.381 d COPP submissio
Pakaistan Arginine………7mg 05-05-2016 is not n of
Private Limited, Amlodipine…………… Rs.50,000/- provided following
65 Main …..5mg a.Approva
Boulevard l status by
Gulberg, (ACE reference
Lahore./ Inhibitors/Calcium regulatory
M/s. Servier channel blockers, ATC) authorities
Deutschland New formulation b.valid
GmbH legalized
Elsenheimerster 02 years COPP
80687 Munich, c.Stability
Germany. data as per
conditions
of Zone
IV A.

153. M/s. Atco Bendamustine Form 5A FDA. COPP Deferred
Laboratories Hydochloride Injection Bendamustine valid for the
Limited, B-18, 100mg Dy. No 308 powder for upto 03- submissio
S.I.T.E. Karachi. Dated 06- infusion by 01-2015. n of GMP
Each vial contains:- 05-2016 M/s Hospira. GMP status of
Manufactured Bendamustine Rs.50,000/- certificat the firm as
by Hydochloride………..1 e not CoPP does
M/s. Fresenius 00mg Rs.25000/v provided. not reflect
Kabi Oncolony Mannitol Ph. ial Stability GMP
Limited, Village Eur……120mg data as status.
KIshanpura, per
P.O. Guru (Lumphocutic condition
Majra, Tehsil leukemia, indolent s of Zone
Nalagarh, Distt. non-Hodgkin’s IV-B
Solan (H.P) 174 lymphoma, multiple attached.
101, India. myeloma)
Manufacturer’s
Specifications
24 months
154. M/s. Amgomed, Amtron 8 mg (2mg/ml) Form 5A MHRA.Ondan COPP Deferred
Office # 5, 1st solution for injection setron 2mg/ml issued on
for
Floor Rose 1, Dy. No by M/s 01-04-clarificatio
Plaza I-8 Each 8mg/4ml ampoule 1039 dated Hameln 2014 by
n of date
Markaz contains: 26.09.2016 Portagal.
of
Islamabad. Ondansetron Rs.100000/ Local. Zofran submissio
Product ………..8mg/4ml - by M/s GSK GMP n of
License Holder complian applicatio
M/s Farmoz- (Antimetics used in As per t as per n
Sociedade cancer induced SRO/ pack COPP.
Tecnico vomiting) of 5
Medicinal’ S.A.
Rua da Tapada Manufacturer’s
Grande, 2, Specifications
Abrunheira 03years
2710-089 Sintra,
Portugal.
Manufactured
by.
M/s
Laboratorios
Vitoria, S.A.
(Fab) Rua Elias

Garcia, 28-
Venda Nova
2700-327
Amadora,
Portugal & M/s.
Atlantic Pharma,
Producoes
Farmacueticals,
SA Rua da
Tapand, n 2
Abruheeira
Sintra, 2710-
089, Portugal
155. M/s. Cyclocure 25mg Form 5A
MHRA. COPP Deferred
Pharmawell Capsule Neoral Soft issued as firm has
(Pvt) Ltd. 244-Y Dated 11- Gelatin dated 03- not
Block, Each soft gel capsule 09-2015 Capsule 25mg 08-2015 submitted
Commercial contains:- vide diary by M/s vide no. real time
Area Phase III, Cyclosporin………….2 No. 309 Novartis 2015052 stability
DHA, Lahore. 5mg Rs.100,000 9 valid data upto
/- upto 2 assigned
M/s. North (Immunosuprent) years. shelf life,
China Co. Ltd, Rs.1940 GMP of Zone
No. 115 Hainan (Manufacturer’s Specs) /50’s valid IV A.
Road, upto 26-
Economic & 24 months 06-2017
Techonological vide no.
Development HF20120
Zone, 014.
Shijiazhuang, Stability
China data as
per
condition
s of Zone
IVA
attached.
156. M/s. Cyclocure 50mg Form 5A COPP Deferred
Pharmawell Capsule issued as firm has
(Pvt) Ltd. 244-Y Dated 11- dated 03- not
Block, Each soft gel capsule 09-2015 08-2015 submitted
Commercial contains:- vide diary vide no. real time
Area Phase III, Cyclosporin………….5 No. 310 2015052 stability
DHA, Lahore. 0mg Rs.100,000 7 valid data upto
/- upto 2 assigned
M/s. North (Immunosuprent) years. shelf life,
China Co. Ltd, Rs.3881 GMP of Zone

No. 115 Hainan (Manufacturer’s Specs) /50’s valid IV A.
Road, upto 26-
Economic & 24 months 06-2017
Techonological vide no.
Development HF20120
Zone, 014.
Shijiazhuang, Stability
China data as
per
condition
s of Zone
IVA
attached
157. M/s. Triumeq Tablet Form 5A COPP Approved
GlaxoSmithKlin issued
e Pakistan Each film coated tablets Dy No. 404 dated10-
Limited, 35- contains:- R&I dated 02-2016
Dockyard Road, Dolutegravir as 24-05-2016 vide No.
West Wharf, sodium……50mg Rs.50,000/- 01/16/95
Karachi-74000. Abacavir as 860 by
sulfate…….600mg Will be EMA.
Market Lamivudine…….300m submitted GMP
Authorization g later complian
Holder t as per
M/s ViiV Anti-HIV, COPP.
Healthcare UK new molecule
Limited, 980
Great West 36 months
Road, Brentford,
Middlesex, TW8
9GS, United
Kingdom
Manufactured
by M/s. Glaxo
Operations UK
Ltd, Priory
Street, Ware,
Hertfordshire
SG12 ODJ,
United
Kingdom.
Site Responsible
for Primary &
Secondary
Packaging

M/s Glaxo
Wellcome S.A.,
Avenida
Extremadura 3,
Aranda de
Duero, Burgos,
09400, Spain.
158. M/s Johnson & Stratafix Knotless tissue Form 5A Certificat Deferred
Johnson control device e to for the
Pakistan Pvt Dy No. 679 foreign expert
Ltd, Karachi Each unit of device dated 11- Governm opinion
Name of contains:- 04-2014 ent No. from
Distributor Polydioxanone/PGA- Rs.50,000. 1171-6- Expert
M/s Ethicon, PCL/Polypropylene 2013 Committe
LLC 475 C Not issued e for
Street Los (Class III Medical mentioned dated 14- Medical
Frailes device) 06-2013 Devices
Industrial Park New Molecule valid (ECMD).
Guaynabo, PR, upto 2
USA 00969 years.
Name of Medical
Manufacturer:- Device
M/s Surgical
Specialities
Puerto Rico,
Inc; Angiotech
PR Inc. Doing
business as
Angiotech
Puerto Rico,
Inc; Road 459
KM 0.6
Montana
Industrial Park
Aguadilla, PR,
USA 00603.
Product Code Product Description
SXMD1B100 PS-1 2-0 PGA-PCL 30CM
SXMD1B101 PS-2 3-0 PDO 45CM
SXMD1B102 PSL 0 PGA-PCL 60CM
SXMD1B402 RB-1 3-0 PGA-PCL 20CM

SXMD1B403 RB-1 2-0 PGA-PCL 20CM
SXMD1B404 RB-1 0 PGA-PCL 20CM
SXMD1B405 SH 2-0 PGA-PCL 20CM
SXMD1B406 SH 0 PGA-PCL 20CM
SXMD1B407 CT-1 2-0 PGA-PCL 45CM
SXMD1B408 CT-1 0 PGA-PCL 45CM
SXMD1B409 CT-1 1 PGA-PCL 45CM
SXMD2B150 2PS-l 3-0 UNO MONODERM 30X30
SXMD2B400 2MH -0- UNDYED MONODERM 14X14
SXMD2B401 2MH -0- UNDYED MONODERM 36X36
SXMD2B402 2R8-1 2-0 U MND 16X1613MM LOR
SXMD2B403 2RB-l 3-0 U MND 16X1613MM LOR
SXMD2B404 2FS-2 2-0 UNDYED MONODERM 7X7
SXMD2B405 2FS-2 3-0 UNDYED MONODERM 7X7
SXMD2B406 2FS-2 2-0 UNDYD MONODERM 14X14
SXMD2B410 2FS-l 2-0 UND MONODERM 30X30
SXMD2B411 2FS 2-0 UNDYD MONODERM 14X14
SXMD2B414 2CP-2 -0- UNDYD MONODERM 14X14
SXPD1B100 PS-2 2-0 PDO 45CM
SXPD1B101 PS-2 3-0 PDO 45CM
SXPD1B400 CT-1 0 PDO 20CM
SXPD1B401 CT-1 0 PDO 30CM
SXPD2B200 20S-6 #2 PDO 24X24
SXPD2B201 20S-6 #2 POD 30 X 30
SXPD2B202 20S-8 #2 PDO 36 X 36
SXPD2B400 2MO-4 #2 PDO 36 X 36
SXPD2B401 2CT-1 -2- PDO 14X 14
SXPD2B402 2CT-1 #2 PD024X24
SXPD2B403 2CT -1 #2 PDO 30 X 30
SXPD2B404 2CT-3-1- PDO 14X14 13MM LDR
SXPD2B405 2CTX #2 PDO 36 X 36
SXPD2B406 2MH -0- PDO 7X7 13MM LEADER
SXPD2B407 2MH -0- PDO 14X1413MMLEADER
SXPD2B409 2MH-1-PDO 14X14
SXPD2B408 2MH -0- PDO 24 X 24

SXPD2B410 2MH #1 PDO 24 X 24
SXPD2B411 2MH #1 PDO 30 X 30
SXPD2B412 2MH -0- PDO 36 X 36
SXPD2B413 2SH-0- PDO 10 X 10 13MM LEADER
SXPD2B414 2SH -0- PDO 14 X 14 13MMLEADER
SXPD2B415 2CP-2 #I PDO 24X24
SXPD2B416 2CP-2 #2 PDO 24 X 24
SXPD2B417 2FS 2-0 PDO 14X14
SXPD2B418 2FS -0- PDO 14 X 14
SXPD2B419 2FS 2-0 PDO 24 X 24
SXPD2B420 2FS -0- PDO 24 X 24
SXPD2B421 2FS-2 4-0 PDO 7 X 7
SXPD2B422 2FS-2 3-0 PDO 7X7
SXPD2B423 2FS-2 3-0 PDO 14 X 14
SXPD2B424 2V-26 3-0 PDO 24 X 24
SXPD2B425 2V-26 3-0 PDO 14X14
SXPD2B426 2V-4 3-0 PDO 24X24
SXPL1B400 DE12 0 PPN 30CM
SXPL2B400 2CT-1 -2- CL PPN 24X24
SXPL2B401 2CT-3 -1- CL PPN 14X1413MM LDR
SXPP1A100 STRATAFIX SYMM PDS PLUS 45cm; PS-1; 3-0; Plastics
SXPP1A101 STRATAFIX SYMM PDS PLUS 45cm; PS-2; 3-0; Plastics
SXPP1A200 STRATAFIX SYMM PDS PLUS 45cm; OS-6; 0; Ortho
SXPP1A201 STRATAFIX SYMM PDS PLUS 45cm; OS-6; 1; Ortho
SXPP1A300 STRATAFIX SYMM PDS PLUS 45cm; CTXB; 1; Ethiguard
SXPP1A301 STRATAFIX SYMM PDS PLUS 45cm; CTB-1; 1; Ethiguard
SXPP1A302 STRATAFIX SYMM PDS PLUS 45cm; CTXB; 0; Ethiguard
SXPP1A400 STRATAFIX SYMM PDS PLUS 45cm; CTX; 1
SXPP1A401 STRATAFIX SYMM PDS PLUS 45cm; CT-1; 0
SXPP1A402 STRATAFIX SYMM PDS PLUS 45cm; CTX; 0
SXPP1A403 STRATAFIX SYMM PDS PLUS 45cm; CT-1; 2-0
SXPP1A405 STRATAFIX SYMM PDS PLUS 45cm; CT; 1
SXPP1A406 STRATAFIX SYMM PDS PLUS 45cm; CT; 0
SXPP1A408 STRATAFIX SYMM PDS PLUS 45cm; CT-2; 2-0
SXPP1A409 STRATAFIX SYMM PDS PLUS 45cm; SH; 2-0
SXPP1A410 STRATAFIX SYMM PDS PLUS 45cm; SH; 3-0
SXMP1B101 MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PS-1

SXMP1B104 MONOCRYL PLUS70CM M -2 USP 3/0 SGLE ARMED PS-1
SXMP1B105 MONOCRYL PLUS15 CM M -2 USP 3/0 SGLE ARMED PS-2
SXMP1B110 MONOCRYL PLUS 30CM M -2 USP 3/0 SGLE ARMED PS
SXMP1B114 MONOCRYL PLUS 30CM M -1.5 USP 4/0 SGLE ARMED PS-1
SXMP1B115 MONOCRYL PLUS 45CM M -1.5USP 4/0 SGLE ARMED PS- 1
SXMP1B116 MONOCRYL PLUS 70CM M -1.5 USP 4/0 SGLE ARMED PS- 1
SXMP1B117 MONOCRYL PLUS 30CM M -1.5 USP 4/0 SGLE ARMED PS-2
SXMP1B118 MONOCRYL PLUS 45CM M -1.5USP 4/0 SGLE ARMED PS- 2
SXMP1B119 MONOCRYL PLUS 70CM M -1.5 USP 4/0 SGLE ARMED PS- 2
SXMP1B120 MONOCRYL PLUS 45CM M1.5 USP 4/0 SGLE ARMED PS-4
SXMP1B408 MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED SH
SXMP1B411 MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED CT-1
SXMP1B412 MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED CT-1
SXMP1B415 MONOCRYL PLUS 15CM M3 USP 2/0 SGLE ARMED CT-2
SXMP1B420 MONOCRYL PLUS 30 CM M3 USP 2/0 SGLE ARMED PSL
SXMP1B421 MONOCRYL PLUS 70 CM M3 USP 2/0 SGLE ARMED PSL
SXMP1B424 MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED RB-1
SXMP1B427 MONOCRYL PLUS 20CM M2 USP3/0 SGLE ARMED SH
SXMP1B428 MONOCRYL PLUS 70CM M2 USP3/0 SGLE ARMED SH
SXMP1B429 MONOCRYL PLUS 45CM M2 USP3/0 SGLE ARMED CT-1
SXMP1B430 MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED BB
SXMP1B431 MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED BB
SXMP1B432 MONOCRYL PLUS 15CM M2 USP3/0 SGLE ARMED ST-4
SXMP1B433 MONOCRYL PLUS 30CM M2 USP3/0 SGLE ARMED ST-4
SXMP1B434 MONOCRYL PLUS 15CM M1.5 USP4/0 SGLE ARMED RB-1

SXMP1B437 MONOCRYL PLUS 70CM M1.5 USP4/0 SGLE ARMED SH
SXPP1B101 PDS PLUS VIO 45CM M3 UPS/2-0 SGLE ARMED FS
SXPP1B102 PDS PLUS VIO 70CM M3UPS/2-0 SGLE ARMED FS
SXPP1B103 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED PS-2
SXPP1B104 PDS PLUS VIO 30CM M2 UPS/3-0 SGL ARMED PS-2
SXPP1B109 PDS PLUS VIO 70 CM M2 UPS/3-0 SGLE ARMED PS
SXPP1B110 PDS PLUS VIO 70 CM M2 UPS/3-0 SGLE ARMED PS-1
SXPP1B111 PDS PLUS VIO 15 CM M2 UPS/4-0 SGLE ARMED PS-2
SXPP1B114 PDS PLUS VIO 70CM M1.5 UPS/4-0 SGLE ARMED PS-2
SXPP1B117 PDS PLUS VIO60CM M2 UPS/4-0 SGLE ARMED PS-1
SXPP1B118 PDS PLUS VIO 45CM M2 UPS/4-0 SGLE ARMED PS
SXPP1B201 PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED OS-6
SXPP1B202 PDS PLUS VIO 45CM M3.5 UPS/0 SGLE ARMED CP-2
SXPP1B205 PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED MO-4
SXPP1B401 PDS PLUS VIO 70CM M4 UPS/1 SGLE ARMED CT X
SXPP1B402 PDS PLUS VIO 90CM M4 UPS/1 SGLE ARMED CTX
SXPP1B403 PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED CP-2
SXPP1B404 PDS PLUS VIO 20CM M3.5 UPS/0 SGLE ARMED V-34
SXPP1B405 PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED CT-2
SXPP1B407 PDS PLUS VIO 45CM M3.5 UPS/0 SGLE ARMEDCT-1
SXPP1B409 PDS PLUS VIO 15CM M3 UPS/2-0 SGLE ARMED CT-1
SXPP1B413 PDS PLUS VIO 15CM M3UPS/2-0 SGLE ARMED CT-2
SXPP1B415 PDS PLUS VIO 15CM M3 UPS/2-0 SGLE ARMED SH

SXPP1B418 PDS PLUS VIO 20CM M3 UPS/2-0 SGLE ARMED V-7
SXPP1B419 PDS PLUS VIO 30CM M3 UPS/2-0 SGLE ARMED UR-6
SXPP1B422 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED RB-1
SXPP1B423 PDS PLUS VIO 70CM M2 UPS/3-0 SGLE ARMED RB-1
SXPP1B424 PDS PLUS VIO 15CM M2 UPS/3-0 SGLE ARMED ST-4
SXPP1B426 PDS PLUS VIO 70CM M1.5UPS/4-0 SGLE ARMED SH
SXPP1B427 PDS PLUS VIO 15CM M1.5UPS/4-0 SGLE ARMED RB-1
SXPP1B428 PDS PLUS VIO 30CM M1.5 UPS/4-0 SGLE ARMED RB-1
SXPP1B429 PDS PLUS VIO 30CM M4UPS/1 SGLE ARMED CT-1
SXPP1B430 PDS PLUS VIO 45CM M4 UPS/1 SGLE ARMED CT-1
SXPP1B431 PDS PLUS VIO 70CM M4UPS/1 SGLE ARMED CT-1
SXPP1B451 PDS PLUS VIO 70 CM M3.5UPS/0 SGLE ARMED M05
SXPP1B452 PDS PLUS VIO 30CM M3.5 UPS/0 SGLE ARMED EN-S
Muhammad Ansar Evaluator-I

Replies of the import cases deferred in 259th meeting of the Registration Board.
159. M/s Tablet Form 5A TGA. The firm Now the Approved
Merixil Azastrole 1mg Azastrole has firm has as per
Pharma, 18-04- 1mg submitted submitted import
Office Each film 2014 vide that in Policy for
#28, 2nd coated tabletdiary No. Arimedex Legalized registration Finished
floor Rose contains:- 314 R&I 1mg by Free sale dossier Drugs.
Plaza, I-8, Anastrozole… Rs.100,0 M/s ICI issued dated license to Product is
Markaz, ….1mg 00. 30-12-2013. manufactur approved
Islamabad. Stability e by TGA
(Treatment of As per data as per therapeutic which is a
Manufact harmone SRO/3x1 conditions goods reference
ured by recpotor 0’s of Zone IV- (Legalized) regulatory
M/s Eris positive A , the anti- authority.
Pharmace advanced Legalized neoplastic
utical breast cancer GMP agents
(Australia) in post certificate tablet
Pty Ltd, 6 menopausal issued dated section is
Eastren women) 25-02-2013. mentioned
Road in its
South Manufacturer’s attachments

Melbourn Specifications furthermore
e VIC the firm has
3205, replied that
Australia. the product
(230) is TGA
approved
brand and
also same
is available
on the site
of TGA.
160. M/s Tablet Gynotril Form 5A TGA. The firm Now the Approved
Merixil 2.5mg Gynotril has firm has as per
Pharma, 18-04- 2.5mg submitted submitted import
#28, 2nd coated tablet diary No. Femara Legalized registration Finished
floor Rose contains:- 313 R&I 2.5mg by Free sale dossier Drugs.
Plaza, I-8, Letrozole…….2 Rs.100,0 M/s issued dated license to Product is
Markaz, .5mg 00. Novartis 30-12-2013. manufactur approved
(231) (Adjuant As per data as per therapeutic which is a
Manufact treatment of SRO/3x1 conditions goods reference
ured by post- 0’s of Zone IV- (Legalized) regulatory
M/s Eris menopausal A , the anti- authority.
Pharmace women with Legalized neoplastic
utical harmone GMP agents
(Australia) recpotor certificate tablet
Pty Ltd, 6 positive issued dated section is
Eastren invasive early 25-02-2013. mentioned
Road breast cancer) in its
South attachments
Melbourn USP furthermore
e VIC Specifications the firm has
3205, replied that
(231) is TGA
approved
brand and
also same
is available
on the site
of TGA.
161. M/s Tablet Bicalox Form 5A TGA. The firm Now the Approved
Merixil 50mg Bicalox has firm has as per
Pharma, 18-04- 50mg submitted:- submitted import

#28, 2nd coated tablet diary No. Casodex Legalized registration Finished
floor Rose contains:- 315 R&I 50mg by Free sale dossier Drugs.
Plaza, I-8, Bicalutamide… Rs.100,0 M/s ICI issued dated license to Product is
Markaz, ….50mg 00. 30-12-2013. manufactur approved
Adjuant to As per data as per therapeutic which is a
Manufact radial SRO/ conditions goods reference
ured by prostectomy or of Zone IV- (Legalized) regulatory
M/s Eris radio-therapy in A , the anti- authority.
Pharmace patients with Legalized neoplastic
utical locally GMP agents
(Australia) advanced certificate tablet
Pty Ltd, 6 prostate cancer issued dated section is
Eastren 25-02-2013. mentioned
Road in its
South USP attachments
Melbourn Specifications furthermore
e VIC the firm has
3205, replied that
(232) is TGA
approved
brand and
also same
is available
on the site
of TGA.
162. M/s Zam Daivobet Gel. Form 5ADenmark The firm Now the Approved
Zam Daivobet has firm has as per
Corporatio Each gm 26-12- Gel by submitted:- replied the import
n, Suit No. contains:- 2013 vide M/s LEO. product is Policy for
205-206, Calcipotriol… diary No. Free sales Denmark Finished
Beaumont …..…50mcg 469 R&I certificate approved Drugs.
Plaza, Betamethasone Rs.50,00 10-12- which is
Beaumont Dipropionate… 0 2012(legali reference
Road, …....0.5mg zed country.
Karachi photocopy).
Manufact Rs.1600/ GMP issued
ured by Topical Vitamin 15gm dated 01-
M/s LEO D analogue & tube 06-2010.
Pharma Steroid.
A/S
Industripa Manufacturer’s
rken 55 Specifications
DK-2750
Ballerup,

Denmark.
(189)
163. M/s Letroze 2.5mg Form 5A TGA. The firm Now the Approved
Amgomed tablet Gynotril has firm has as per
, office 11-04- 2.5mg submitted submitted import
No. 05, 1st Each film 2014 vide the GMP Policy for
floor, coated tablet diary No. Femara COPP legalized Finished
Rose 1 contains:- 297 R&I 2.5mg by Legalized which Drugs.
Plaza, I-8, Letrozole…….2 Rs.100,0 M/s issued dated shows the
Markaz, .5mg 00 Novartis 19-11-2013. details of
Islamabad. Firm is sections i.e
From (Adjuant GMP firm has
Manufactu treatment of As per compliant non sterile
red By post- SRO/30 as per antineoplas
M/s West menopausal tablets COPP tic tablet
Pharma, women with Legalized section.
Producoes harmone issued dated
de recpotor 19-11-2013.
Especialia positive Stability
es invasive early data as per
Farmaceut breast cancer) conditions
icas, SA of Zone IV-
Rua Joao USP A.
De Deus, Specifications
n. 11,
Amadora,
2700-486,
Portugal.
(227)
164. M/s Vesna Injection Form 5A MHRA. The firm Now the Approved
Revive 200mg Mesna has firm has as per
Healthcare 02-08- 200mg/2 submitted submitted import
, Office Each 1ml 2013 vide ml by Legalized the COPP Policy for
503, 5th contains:- diary No. M/s COPP valid for the Finished
Floor, 6 Sodium-2- 1001 R&I Claris upto 10-09- Vesna valid Drugs.
Main Sulphanylethan Rs.100,0 Lifescien 2013. upto 10-05-
Gulberg, esulphonate 00 ces UK. Stability 2017 which
Jail Road, BP……100mg data as per shows that
Lahore, conditions the product
Pakistan. Antineoplastic As per of Zone IV- is available
Agent SRO/2ml A. in alone.
Manufactu ampoule Legalized
red by USP GMP dated
M/s Specifications 13.09.2010.

United
Biotech
(P) Ltd.
FC/B-1
(Extn.)
Mohan
Cooperati
ve
Industrial
Estate,
Mathura
Road,
New
Delhi-
110044,
India.
(129)
The following product of M/s. Revive Health Care, Lahore was discussed in the 243rd meeting of
the board and was approved.
It is submitted that there is a typographical mistake in the formulation the Sodium 2-

Sulphanylethansulphonate 100mg were written inadvertently.
M/s. Revive Health Care, Ifomid-M 1gm Injection As per 02 years Approved as
Lahore. / Each vial contains:- SRO/PRC per import
M/s. United Biotech (P) Ifosfamide…………….1gm Policy for
Limited, Bagbani, Baddi, Sodium 2- Finished
Nalagarh Road, District, Sulphanylethansulphonate Drugs.
Solan, India. BP……………..……100mg
(ATC Class: L01AA06).
The correct formulation is as under
165. M/s. Revive Health Care, Ifomid-M 1gm Injection As per 02 years valid COPP Approved as
Lahore. / Each vial contains:- SRO/PRC valid upto per import
M/s. United Biotech (P) Ifosfamide…………….1gm 10-05-2017 Policy for
Limited, Bagbani, Baddi, Finished
Nalagarh Road, District, (ATC Class: L01AA06). Drugs.
Solan, India.

Replies of product deferred in 254th meeting of the Board.
166. Importer KETOFAST Form- International Deferred for: Legalized Deferred for
M/s Efroz Cataplasma 5A availibility Evidence of GMP the
Chemical not approval of issued confirmation
Industries (Pvt) Each sheet (9x13cm2, Dy No confirmed. same dosage dated 28- of approval
Limited, 12-C 11.7gm) contains: : 468 form, generic 01-2016 status by
Block 6, Ketoprofen…..25.07mg dated Kefentech and strength by Korea. reference
P.E.C.H.S. off 26-01- Plaster by in reference Legalized regulatory
Shahrah-e- NSAID 11 M/s Matrix drug agency. COPP authorities
Faisal, Karachi 15000/- Reg Confirmation issued
Manufacturer Manufacturer dated #047624. of address of dated 26-
M/s Dae Hwa 26-01- the 05-2016
Pharmaceuticals 11 manufacturer by Korea.
Co., Ltd 85000/- of the Product is
495- Hanu-ro-, dated applied in free
Hoenseong-eup, 19-02- product as sale in
Hoenseong, 14 the address Korea.
Gangwon-do, mentioned Local
Republic of Rs. on Form-5A Kefentech
Korea. 500/- & GMP is by M/s
Per 6’s different Matrix.
Sheets from the
address
mentioned in
the COPP.
Moreover,
address of
manufacturer
on sole
agency
agreement is
different
from address
of above
mentioned
documents.
Clarfication
that applied
drug is
generic

product
hence
clinical data
and clinical
justification
is not
required.
Stability data
as per
WHO/ICH
Zone-IV A.

Routine Import Applications
Veterinary Import applications Routine
Decision
167. M/s. Ghazi Spectramast DC Form 5-A FDA. COPP Approved

Brothers, Suspension Ceftifur issued by as per
Karachi-75350. Each 10ml Plastet Rs. 50,000/- 500mg by US FDA import
/ Disposable Syringe vide Dy. No. M/s M/s. dated 20- Policy for
M/s. Pharmacia contains:- 628 dated 29- Pharmacia 03-2013. Finished
& Upjohn Ceftiofur 05-2013 & Upjohn GMP Drugs.
Company A Equivalents (as the compliant
Division of hydrochloride Decontrolled/1 as per
Pfizer Inc. sale)…500mg 0ml COPP.
Kalamazoo,
Michigan, (Antibiotic).
U.S.A.
Manufacturer’s
362 specifications
168. M/s. Ghazai Spectramast LC Form 5-A FDA. COPP Approved
Brothers, Suspension Ceftifur issued by as per
Karachi-75350. Rs. 50,000/- 250mg by US FDA import
/ Each 10ml Plastet vide Dy. No. M/s M/s. dated 09- Policy for
M/s. Pharmacia Disposable Syringe 627 dated 29- Pharmacia 10-2015. Finished
& Upjohn contains:- 05-2013 & Upjohn GMP Drugs.
Company A Ceftiofur compliant
Division of Equivalents to Decontrolled/1 as per
Pfizer Inc. Ceftiofur …125mg 0ml COPP.
Kalamazoo,
Michigan, (Antibiotic).
U.S.A.

Manufacturer’s
363 specifications
24 Months
169. M/s. Ghazi ADEFORTEX Form 5-A Free sale Approved
Brothers, Injectable Solution Local. issued as per
Ghazi House, Dy. No. 211 Duravit dated 19- import
D-35. K.D.A. Each mL contains:- R&I Rs. AD3E 12-2012. Policy for
Scheme No.1, Vitamin A (Palmitic 50,000/- dated Injection by GMP Finished
Miran ester of Vitamin 19-03-2014 & M/s Mylab. issued Drugs.
Muhammad A)……………500,0 Rs. 50,000 dated 06-
Shah Road, 00 I.U dated 30-07- 02-2013.
Karachi-75350 Vitamin D3 (Pure 2016 dy No.
Cholecalciferol)….. 822.
Product 75,000 I.U
License Vitamin E (Alpha- Decontrolled/1
Holder:- Tocopherol 00ml
M/s. Agrovet Acetate)……………
Market S.A., ..50mg
Av. Canada
3792 San Luis, Vitamin
Lima, Peru. Supplement.
Manufacturer
Under Product Manufacturer’s
License Specifications
Holder:-
M/s. Pharmadix 03 years
Corp. S.A.C.
Urbanizacion La
Aurora-Ate
Lima 3-Peru.
426
170. M/s. Ghazi Ovuprost Aqueous Form 5-A Free sales Approved
Brothers, Injectable Solution Delzamazin certificate as per
Karachi. Rs. 50,000/- by M/s Prix issued import
Each mL contains:- vide Dy. No. dated 11- Policy for
M/s. Bayer New Cloprostenol (as 53 dated 6-01- 10-2012. Finished
Zealand Sodium)…..250ug 2014 & GMP Drugs.
Limited, Rs.50,000 issued
Hillcrest, Gynaecologicals- dated 30-07- dated 15-
Auckland, New Oxytocics. 2016 dy 05-2013.
Zealand. No.820.
B.P Specifications
410 Decontrolled/

171. M/s. Ghazi Ectomethrn 200 Form 5-A Free sales Approved
Brothers, Emulsion liquid. certificate as per
Ghazi House, Rs. 50,000/- Local. issued import
D-35. K.D.A. Each mL vide Dy. No. Cypothern dated 29- Policy for
Scheme No.1, emulsifiable 212 dated 19- 200 10-2013. Finished
Miran concentrate 03-2014 & Rs Solution by GMP Drugs.
Muhammad contains:- 50,000 dated star compliant
Shah Road, Cypermethrin…...20 30-07-2016 issued
Karachi-75350 0mg Dy No.821. dated29-
10-2013.
Product License Ectoparasiticide. Decontrolled/
Holder:- 10ml, 20ml,
M/s. Agrovet Manufacturer’s 50ml, 100ml,
Market S.A., Specifications 250ml, 500ml
San Luis, Lima, & 1 litre.
Peru.
Manufacturer
Under Product
License
Holder:-
M/s. Pharmadix
Corp. S.A.C.
Urbanizacion La
Aurora-Ate
Lima 3-Peru.
429
172. M/s. Ghazi Cevasametrina 20 Form 5-A Free sales Approved
Brothers, Emulsion solution. Local. certificate as per
Ghazi House, Rs. 50,000/- Cypothrin issued import
D-35. K.D.A. Each 100mL vide Dy. No. 20 by Star dated 26- Policy for
Scheme No.1, emulsifiable 209 dated 19- labs 09-2012. Finished
Miran concentrate 03-2014 & GMP Drugs.
Muhammad contains:- Rs.50,000 compliant
Shah Road, Cypermethrin…...20 dated 30-07- as per
Karachi g 2016 dy No. FSC dated
823. 26-09-
Product License Ectoparasiticide. 2012.
Holder. Decontrolled/
M/s Cevasa S.A Manufacturer’s 20ml, 50ml,
23rd Street N Specifications 100ml, 500ml
293 Pilar & 1 litre.
Industrial Park,
Pilar State of
Buenos Aires,

Argentina.
Manufactured
by.
Midori S.R.L,
Stephenson
3294,
Tortuguitas,
Buenos Aires,
Argentina
425
Human Import Applications Routine
173. M/s Novartis Micocept Form 5-A COPP Approved

Pharma Capsule issued as per
(Pakistan), Dairy No. dated 17- Import
Limited 15 West Each Capsule 1263 12-2014 policy for
Wharf, Karachi Contains: dated 21-12- by TGA. Finished
Mycophenolate 2012 GMP Drugs and
Manufactured Mofetil………...250 Rs.100000/- compliant complianc
by mg as per e of Import
M/s Sandoz Rs.2925/- CoPP. Policy
Private Ltd. (Immunosuppressant /50tabs CoPP Order,
MIDC Plot No. ) Rs.58.50/Tab valid upto 2016
8-A/2 & 8-B 20-03-
TTC Industrial Manufacturer’s 2015 by
area Kalwe Specifications India.
Block Village GMP
Dighe Navi , valid upto
Mumbai, India. 20-03-
195 2015.
174. M/s Novartis Micocept Form 5-A COPP
Pharma Film coated tablets issued
(Pakistan), Dairy No. dated 17-
Limited 15 West Each film coated 1264 12-2014
Wharf, Karachi tablet Contains: dated 21-12- by TGA.
Mycophenolate 2012 GMP
M/s Sandoz Mofetil……..500mg Rs.100000/- compliant
Private Ltd. as per
MIDC Plot No. (Immunosuppressant Rs.6000/- CoPP.
8-A/2 & 8-B ) /50tabs CoPP
TTC Industrial Rs.120/Tab valid upto
area Kalwe Manufacturer’s 20-03-
Block Village Specifications 2015 by

Dighe Navi , India.
Mumbai, India. GMP
valid upto
94 20-03-
2015.
175. M/s Umar Femaplex 2.5mg Form 5A MHRA. COPP Approved
Pharma Pvt Ltd, tablet Femra issued as per
C 5/6, Auqaf Dy No. 1071 2.5mg f/c dated 25- Import
Plaza Dabgari Each film coated dated 20-08- tablet by 06-2013. Policy for
Garden, tablet contains:- 2013 M/s GMP Finished
Peshwar. Letrozole….2.5mg Rs.100,000/ Novartis. compliant Drugs.
Manufactured (Adjuant treatment as per Panel shall
by of post-menopausal As per SRO Local. COPP. confirm
M/s women with Femra the
Genepharma harmone recpotor 2.5mg by anticancer
S.A, 18th Km, positive invasive M/s facility for
Marathonosaven early breast Novartis. the
ue-15351, cancer). manufactu
Pallini-Greece. USP Specifications ring of the
drug at the
131 time of
foreign
inspection.
176. M/s Umar Zymoplex 20mg Form 5A MHRA. COPP Approved
Pharma Pvt Ltd, tablet Soltamox issued as per
C 5/6, Auqaf Dy No. 1070 20mg tablet dated 25- Import
Plaza Dabgari Each tablet dated 20-08- by M/s 06-2013. Policy for
Garden, contains:- 2013 Aurobindo. GMP Finished
Peshwar. Tamoxifen Citrate Rs.100,000/ compliant Drugs.
Manufactured eq to Local. as per Panel shall
by Tamoxifen…….20m As per SRO Cytotam by COPP. confirm
M/s g M/s AJ the
Genepharma Mirza. anticancer
S.A, 18th Km, Oestrogen Receptor facility for
Marathonosaven Positive Early Breast the
ue-15351, Cancer manufactu
Pallini-Greece. ring of the
drug at the
133 time of
foreign
inspection.
177. M/s Umar Zymoplex 10mg Form 5A TGA. COPP Approved
Pharma Pvt Ltd, tablet Cosudex issued as per
C 5/6, Auqaf Dy No. 1068 50mg by dated 25- Import
Plaza Dabgari Each tablet dated 20-08- M/s 06-2013. Policy for
Garden, contains:- 2013 Astrazeneca GMP Finished

Peshwar. Tamoxifen Citrate Rs.100,000/ . compliant Drugs.
Manufactured eq to as per Panel shall
by Tamoxifen…….10m As per SRO Local. COPP. confirm
M/s g Calutide by the
Genepharma M/s AJ anticancer
S.A, 18th Km, Oestrogen Receptor Mirza. facility for
Marathonosaven Positive Early Breast the
ue-15351, Cancer manufactu
Pallini-Greece. ring of the
132 drug at the
time of
foreign
inspection.
178. M/s Umar Bicamide 50mg Form 5A MHRA. COPP Approved
Pharma Pvt Ltd, tablet Soltamox issued as per
C 5/6, Auqaf Dy No. 1069 20mg tablet dated 25- Import
Plaza Dabgari Each film coated dated 20-08- by M/s 06-2013. Policy for
Garden, tablet contains:- 2013 Aurobindo. GMP Finished
Peshwar. Bicalutamide…….5 Rs.100,000/ compliant Drugs.
Manufactured 0mg Local. as per Panel shall
by As per SRO Arimidex COPP. confirm
M/s Adjuant to radial by M/s ICI. the
Genepharma prostectomy or anticancer
S.A, 18th Km, radio-therapy in facility for
Marathonosaven patients with locally the
ue-15351, advanced prostate manufactu
Pallini-Greece. cancer ring of the
130 drug at the
time of
foreign
inspection.
179. M/s A. Feroz & Star Haemopack Form 5A COPP Approved
Co, Medicine Single Blood Bag issued as per
Street No. 01, Dy No.1495 dated 03- Import
Marriot Road, Each 100ml of R&I dated 12- 02-2014 Policy For
Karachi. anticoagulant 03-2013 Rs. valid upto Finished
Manufactured solution CPDA-1 50,000 & Rs. 2 years. Drugs
by contains:- 50,000 dated GMP
M/s HLL Citric acid 05-11-2013 dy compliant
Lifecare (Anhydrous)………. No.303. as per
Limited .…..0.299gm COPP.
Akkulam, Sodium Citrate As per Brand
Thiruvananthap (Dihydrate)…..2.63g leader/500ml
uran Kerala, m
India. Monobasic Sodium
102 Phosphate

(Monohydrate)……
…….0.222gm
Dextrose
(Anhydrous)………
……..2.90gm
Adenine
(Anhydrous)…..0.02
75gm
WFI…….QS to
100ml
Anticoagulant
Solution
Manufacturer’s
Specifications
180. M/s A. Feroz & Star Haemopack Form 5A COPP Approved
Co, Medicine Double Blood Bag issued as per
Street No. 01, Dy No.1496 dated 03- Import
Marriot Road, Each 100ml of R&I dated 12- 02-2014 Policy For
Karachi. anticoagulant 03-2013 Rs. valid upto Finished
Manufactured solution CPDA-1 50,000& Rs. 2 years. Drugs
by contains:- 50,000 dated GMP
M/s HLL Citric acid 05-11-2013 dy compliant
Lifecare (Anhydrous)………. No.303. as per
Limited .…..0.299gm COPP.
Akkulam, Sodium Citrate
Thiruvananthap (Dihydrate)…..2.63g As per Brand
uran Kerala, m leader/500ml
India. Monobasic Sodium
Phosphate
103 (Monohydrate)……
…….0.222gm
Dextrose
(Anhydrous)………
……..2.90gm
Adenine
(Anhydrous)…..0.02
75gm
WFI…….QS to
100ml
Anticoagulant
Solution
Manufacturer’s

Specifications
181. M/s A.Feroz Star PGA Suture Form 5A Sizes. USP Free sale Deferred
& with needle 5-0~USP 3 certificate for
Co Medicine Diary No. With round is valid submission
Street PGA is a synthetic 174 R&I & reverse upto 21- of complete
no.1,Marriot absorbable surgical dated 22-06- cutting 02-2013. details
regarding
road, Karachi, suture with needle. 2011 sizes and
Pakistan. Rs.15000& shapes of
Rs.85,000 sutures
Manufactured PGA dated 04-11-
by (Polyglycolicacid) 2013 dy No.
Shanghai Suture 208 R&I
Pudong .
Jinhuan Medical Sutures
Products As per SRO
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
182. M/s A.Feroz Star Nylon Suture Form 5A Sizes. USP Free sale Deferred
& with Needle 6-0~USP 1 certificate for
Street Nylon Suture is a 181 R&I cutting, upto 21- of complete
no.1,Marriot monofilament of dated 22-06- normal 02-2013. details
regarding
road, Karachi, Polyamide Nylon & 2011 cutting & sizes and
Pakistan. the material is non- Rs.15000 & reverse shapes of
absorable. Rs.85,000 cutting sutures
Manufactured dated 04-11-
by Suture 2013 dy No.
Shanghai 208 R&I
Pudong .
Jinhuan Medical
Products As per SRO
Co.,Ltd.
25 LianZhen
Road,Pudong
New

Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
183. M/s A.Feroz Star Chromic Catgut Form 5A Sizes. USP Free sale Deferred
& Suture with needle. 4-0~USP 2 certificate for
Street Chromic catgut is 178 R&I & reverse upto 21- of complete
no.1,Marriot BSE Free & dated 22-06- cutting 02-2013. details
regarding
road, Karachi, produced from 2011
sizes and
Pakistan. intestinal serosa. Rs.15000 & shapes of
Rs.85,000 sutures
Manufactured Suture. dated 04-11-
by 2013 dy No.
Shanghai 208 R&I
Pudong .
Jinhuan Medical
Products As per SRO
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
184. M/s A.Feroz Star Polypropylene Form 5A Sizes. USP Free sale Deferred
& Suture with needle. 5-0~USP 2 certificate for
Co Medicine Diary No. With round, is valid submission
Street Polypropylene 180 R&I round upto 21- of complete
no.1,Marriot Suture is a dated 22-06- double, 02-2013. details
regarding
road, Karachi, monofilament. 2011 straight
sizes and
Pakistan. Rs.15000 & cutting & shapes of
Suture. Rs.85,000 reverse sutures
Manufactured dated 04-11- cutting
by 2013 dy No.
Shanghai 208 R&I
Pudong .
Jinhuan Medical
Products As per SRO

Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
185. M/s A.Feroz Star Polyester Suture Form 5A Sizes. USP Free sale Deferred
Street 176 R&I & reverse upto 21- of complete
no.1,Marriot Braided polyester dated 22-06- cutting 02-2013. details
regarding
road, Karachi, suture. 2011
sizes and
Pakistan. Rs.15000 & shapes of
Suture Rs.85,000 sutures
Manufactured dated 04-11-
by 2013 dy No.
Shanghai 208 R&I
Pudong .
Jinhuan Medical
Products As per SRO
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
186. M/s A.Feroz Star PGA Suture Form 5A Sizes. USP Free sale Deferred
Street PGLA-Poly 177 R&I & reverse upto 21- of complete
no.1,Marriot (glycolide-co dated 22-06- cutting 02-2013. details
regarding
road, Karachi, lactide) (90/10) 2011
sizes and
Pakistan. braided, coated Rs.15000 & shapes of
synthetic absorbable Rs.85,000 sutures
Manufactured surgical suture. dated 04-11-
by 2013 dy No.

Shanghai Suture 208 R&I
Pudong
Jinhuan Medical As per SRO
Products
Co.,Ltd.
25 LianZhen
Road,Pudong
New
Area,Shanghai,
China 201204.
No.F.3-3/2014
Reg.I(M-244)
dated
26.09.2016
187. M/s Samerians MASTER Suture Form 5A Shape Deferred
Enterprise, 4- Polyglycolic with Normal for
First Floor, H.J. Needles Diary No. cutting submission
centre Kuchi 233 R&I with sizes of complete
Gali No.2, Suture dated 10-10- 3/8, 1/2,, details
regarding
Marriot Road, 2013 Reverse
sizes and
Karachi. Rs.100000 Cutting shapes of
Manufacture with sutures
by As per SRO sizes3/8,
M/s Medico 1/2, and
(Huaian) Co. round
Ltd, No.09 with sizes
South Free sales
Guangzhou certificate
Road 223005, issued
Huaian, dated27-
Jiangsu, China 05-2013
164
Enterprise, 4- Chromic Catgut with Normal for
First Floor, H.J. Needles Diary No. 90 cutting submission
centre Kuchi R&I dated 24- with sizes of complete
Gali No.2, 1-2014 3/8, 1/2,, details
regarding
Marriot Road, Suture Rs.100000 Reverse
sizes and
Karachi. Cutting shapes of
Manufacture As per SRO with sutures
by sizes3/8,
M/s Medico 1/2, and
(Huaian) Co. round

South Free sales
Road 223005, issued
Huaian, dated27-
197
Enterprise, 4- Polypropylene with Normal for
First Floor, H.J. Needles Diary No. cutting submission
centre Kuchi 232 R&I with sizes of complete
Gali No.2, dated 10-10- 3/8, 1/2,, details
regarding
Marriot Road, Suture 2013 Reverse
sizes and
Karachi. Rs.100000 Cutting shapes of
Manufacture with sutures
by As per SRO sizes3/8,
M/s Medico 1/2, and
(Huaian) Co. round
South Free sales
Road 223005, issued
Huaian, dated27-
165
Enterprise, 4- Silk Braided with Normal for
First Floor, H.J. Needles Diary No. 91 cutting submission
centre Kuchi R&I dated 24- with sizes of complete
Gali No.2, 1-2014 3/8, 1/2,, details
regarding
Marriot Road, Suture Rs.100000 Reverse
sizes and
Karachi. Cutting shapes of
Manufacture As per SRO with sutures
by sizes3/8,
M/s Medico 1/2, and
(Huaian) Co. round
South Free sales
Road 223005, issued
Huaian, dated27-
196

191. M/s Novartis Sandimmun Neural Form 5A COPP Deferred
Pharma Pakistan 50mg issued by for
Ltd, Karachi Dy No. 235 TGA submission
Manufactured Each capsule dated 21-03- dated 13- of CoPP to
By contains:- 2014 11-2013. confirm
M/s Catalent Cyclosporin……50 Rs.10,000. GMP free sale
Germany mg compliant
Eberbach As per SRO as per
GmbH, Immunosuprassant COPP.
Gammelsbacher
Strasse 2
Eberbach D-
69412 Germany
Name and
address of
Applicant
M/s Novartis
Pharmaceuticals
Australia Pty
Ltd, 54
Waterloo Road,
North Ryde
NSW 2113,
Australia
221

Routine applications for local manufacturer.
S/N Name and Brand Name Type of Remarks on the Remarks Decision
address of (Proprietary name + Dosage Form formulation (if by
manufacturer / Form + Strength) any) including Evaluator/
Applicant Initial date, International Decision
Composition diary status in stringent
drug regulatory
Pharmacological Group Fee agencies /
including authorities
Finished product Specification differential
fee Me-too status
Demanded GMP status as

Price / Pack depicted in latest
size inspection report
(with date) by the
Evaluator
192. M/s Medicraft Irose Injection 5ml Form 5 MHRA. Venofer Approved
Pharmaceuticals by M/s Vifor
Pvt Ltd, Each ml contains:- 25-03-2013
Industrial Estate, Iron sucrose complex eq to vide diary Local. Venofer
Hayatabad, elemental 182 (R&I) by M/s RG
Peshawar iron………..………20mg Rs.20,000.
Haematinic GMP compliant
2201 USP Specifications As per SRO as per inspection
report dated 27-
05-2016.
193. M/s Safe Fayneec Capsule 50mg Form 5 Deflamat 50mg- Fee Approved.
Pharmaceuticals Kapseln by M/s Rs.8000 & Photocopy
Pvt Ltd, Karachi Each capsule contains:- Dy No. Nil Astellas Pharma Rs.12,000/- fee
Diclofenac Sodium as SR dated 17-02- GmbH Austria. are challanswill
Source of pellets………..………50mg 2010 photocopy. be verified
Pellets Rs.8000 Local. Mobikare by Budget &
M/s Vision Anti-Rheumatics (Photocopy) 50mg by M/s Accounts
Pharmaceuticals & 22-05- Barrett Hodgson Division and
Kahuta road, USP Specifications 2013 Chairman
Islamabad Rs.12000 GMP compliant Registration
(Photocopy) as per inspection Board will
15 report dated 09- permit
As per SRO 06-2015. issuance of
registration
letter.

194. M/s Rasco Pioglimp-DS tablet Form 5 FDA. Duetact Fee Approved.
Pharma, 5.5 Km 4mg/30mg by Rs.8000 is Photocopy
Raiwind road, Each tablet contains:- Dy No. nil M/s Takeda a fee
Lahore. Pioglitazone as dated 29-06- photocopy. challanswill
HCl………..………30mg 2012 Local. Piotone be verified
(1784) Glimepiride………..4mg Rs.8000 4/30 by M/s by Budget &
(Photocopy) Atco. Accounts
Anti diabetic & Rs.12,000 Division and
dated 30-07- GMP compliant Chairman
Manufacturer’s Specifications 2013 dy no. as per inspection Registration
9349 R&I. date 09-09-2015. Board will
permit
As per SRO issuance of
registration
letter.
195. M/s Care Carnyl Syrup Form 5 MHRA. Bricanyl Fee Approved.
Pharmaceuticals, 0.3mg/ml Syrup Rs.8000 & Photocopy
8-Km Raiwind Each ml contains:- Dy No. nil by M/s 12000 are fee
road, Lahore. Terbutaline dated 24-05- AstraZeneca. photocopy. challanswill
Sulphate………..………0.3mg 2011 be verified
(1004) Rs.8000 Local. Britanyl by Budget &
Bronchodialator (Photocopy) by M/s Barrett Accounts
& Rs.12,000 Hodgson Division and
Manufacturer’s Specifications dated 30-07- Chairman
2013 GMP compliant Registration
(Photocopy). as per inspection Board will
date 19-12-2014. permit
As per SRO issuance of
registration
letter.
196. -do- Hepacare Syrup Form 5 Fee Deferred for
(1069) Rs.8000 & the
Each 5ml contains:- Dy No. nil Local Hepa-Merz 12000 are confirmation
L-Ornithine L- dated 24-05- by M/s Brookes photocopy. of approval
Aspartate…………300mg 2011 Approval status by
Nicotinamide………..…24mg Rs.8000 GMP compliant status in regulatory
Riboflavin sodium (Photocopy) as per inspection reference authorities
phosphate….……….0.76mg & Rs.12,000 date 19-12-2014. countries is of reference
dated 30-07- not countries
Liver Supplement 2013 provided.
(Photocopy).
Manufacturer’s Specifications
As per SRO
197. M/s Amarant Tica 90mg tablet Form-5 FDA. Brilinta Approval Deferred for
Pharmaceuticals Each tablet contains:- 21-08-2013 90mg & 60mg by status in the

(Pvt) Ltd, 158, Ticagrelor………90mg vide diary M/s Astrazeneca Pakistan is confirmation
D. Tore, Gadap Anti-coagulant No. 1560 GMP compliant not of approval
Road, Super Manufacturer’s Specifications R&I as per inspection provided. status in
Highway, Rs.20,000. dated 04-11- Pakistan
Karachi. As per 2015.
(2513) SRO/30’s.
198. -do- Esonap Tablet 375/20mg Form-5 FDA. Vimovo Approval Deferred for
(2514) Each tablet contains:- 21-08-2013 delay release status in confirmation
Naproxen………….375mg vide diary tablet 20/375mg Pakistan is of approval
Esomeprazole No. 1559 by M/s Horizon not status in
Magnesium….……..20mg R&I GMP compliant provided. Pakistan
Analgesic/PPI Rs.20,000. as per inspection
Manufacturer’s Specifications As per dated 04-11-
SRO/30’s. 2015.
199. -do- Mafinil 100mg tablets Form-5 MHRA.Modafinil Approved

(2515) Each tablet contains:- 21-08-2013 100mg by M/s
Modafinil……100mg vide diary Teva
Psychotic drug No. 1561 Local. V-Zac
USP Specifications R&I 100mg tablet by
Rs.20,000. M/s Wilshire
As per GMP compliant
SRO/20’s. as per inspection
dated 04-11-
2015.

Replies of Products deferred in 258th meeting of the Board.
200.M/s Sami Stein 175mg/5ml Form-5 Denmark. Deferred for It has been Approved.
Pharmaceuticals Suspension 4-08-2012 Erodin the Following verified Photocopy
Pvt Ltd, Each 5ml of vide 175mg/5ml by verification that the fee
Karachi. reconstituted diary No. M/s Orion of Fee. product is challanswill
suspension contains:- Nil Rs.8000. in free sale be verified
1892 Erdosteine Rs.8,000 Local. Erdos Approval in by Budget
MS……..175mg (Photocopy) suspension status Denmark & Accounts
(Mucolytic) & 175mg/5ml by inreference Division
Manufacturer’s 12,000 M/s Genome. Regulatory and
Specifications dated 29- authorities. Chairman
07-2013. Registration
Rs. Board will
178/100ml permit
issuance of
registration
letter
201.-do- Stein 150mg Capsule Form-5 Denmark. Deferred for It has been Approved.
Each Capsule 4-08-2012 Erdotin 150mg the verified Photocopy
1891 contains:- vide capsule by M/s Following that the fee
Erdosteine diary No. Orion pharma. verification product is challanswill
MS………..150mg Nil Local. Erdos of Fee. in free sale be verified
(Mucolytic) Rs.8,000 capsule 150mg Rs.8000. in by Budget
Manufacturer’s (Photocopy) by M/s Approval Denmark & Accounts
Specifications & Genome status Division
12,000 inreference and
dated 29- Regulatory Chairman
07-2013. authorities. Registration
Rs. 178/ 20 Board will
Capsules permit
issuance of
registration
letter
202.M/s Barett Mobikare Plus Form-5 Arthrotec Deferred in Copy of Fee Deferred for
Hodgson Tablet Dy. No: 159 MHRA, FDA 255th meeting Challan confirmation
Each tablet contains: dated. for: provided. of double
Karachi. Misoprostol……..200mcg 15-07-2010 Cytopan (Getz) Original fee Commitment punch/layer
Diclofenac Sodium …. Rs.8000/- Challan of Rs: provided machine from
94 75mg Rs.12,000/- 12000/-. Me too area FID.
(Non-Steroidal 2x10’s / Commitment as product, so
Antiinfammatory Rs.450/- per 251st stability not
with Synthetic meeting. required.
Prostaglandin E1 analog) Last inspection Inspection
report. report dated
Reply of letter 03.02.16
no. provided.

F.6- Picture of
12/2013Reg-II machine
dated 01 along with
October invoice
2013 not provided.
satisfactory but
board decided to
submit stability
studies in
previous
meeting.
Proof of double
core
compression
machine
required. for
stability studies
was dispensing
10-09- 2010 and
Manufacturing
date 27-08-09.
Supportive data
Stability studies
as per RB
decision in 251st
meeting.
203.-do- Mobikare Plus Tablet Form-5 FDA Arthrotec Deferred for in Picture of Deferred for
Each tablet contains:- 15-06-2010 Tablet by M/s 254th meeting of machine confirmation
Diclofenac vide diary # Searle. RB along with of double
95 Sodium……...….50mg 160 Rs.8000 Double invoice punch/layer
Misoprostol………200mcg R&I & 21-05- Arthrotec Tablet compression provided. machine from
NSAID+Prostaglandin 2013 diary # by M/s Pfizer. machine require Commitment area FID and
analogue ___ Rs.12000 to be verified. provided. fee challan.
Manufacturer’s Photocopy Commitment as Inspection
Specifications attached per the decision report dated
As per SRO of RB is not 03.02.16.
attached. Copy of fee
Fresh inspection Challan
report conducted provided.
within the
period of 1 year
is not attached.
Outline method
of manufacture
is not provided.
Photocopy of
fee Rs.12000
attached original
is required.
204.M/s Sami NovoTeph DR Sachet Form-5 Nexium Sachet Deferred for Approved
Pharma, 20mg Dy. No: of AstraZeneca rectification
Karachi. Each sachet contains: 8000/- dated USA of following:
Deferred in Enteric coated 31-12-10 Nexum Source of
250th meeting granules (22.5%) of 12000/- delayed relaese Esomeprazole

Esomeprazole dated 29-07- Sachet of granules,
744 magnesium Trihydrate 13 Getz(Approved their
eq to & Rs.80,000 in 227th composition,
Esomeprazole…20mg vide dy No. meeting of certificate of
PPI 2791 R&I RB) analysis,
Manufacturer dated 17-06- stability
2016 studies as per
Source Of Pellets. zone IV and
M/s RA Chem Pharma Rs. 450/- in case of
Ltd, Plot #A-19/C Pack of 14’s import of
Road No.18 IDA, pellets,
Nacharam Hydrabad, legalized
Andhrapradesh, India GMP
certificate of
the source
along with
the requisite
fee prescribed
under the
rules is not
submitted.
205.-do- NovoTeph DR Sachet Form-5 Nexium Sachet Deferred for Approved

Deferred in 40mg Dy. No: of AstraZeneca rectification
250th meeting Each sachet contains:8000/- dated USA of following:
Enteric coated 31-12-10 Nexum Source of
746 granules (22.5%) of 12000/- delayed relaese Esomeprazole
Esomeprazole dated 29-07- Sachet of granules,
magnesium Trihydrate 13 Getz(Approved their
eq. to Rs. 1800/-& in 227th composition,
Esomeprazole…40mg Rs.80,000 meeting of certificate of
PPI vide dy No. RB) analysis,
Manufacturer 2792 R&I stability
dated 17-06- studies as per
Source Of Pellets. 2016 zone IV and
M/s RA Chem Pharma Pack of in case of
Ltd, Plot #A-19/C 14’s import of
Road No.18 IDA, pellets,
Nacharam Hydrabad, legalized
Andhrapradesh, India GMP
certificate of
the source
along with
the requisite
fee prescribed
under the

rules is not
submitted.

Evaluator-IV Mr. Salateen Wasim Philip
Routine cases:-
S/N Name and Brand Name Type of Form International Remarks / Decision
address of status in Observation
manufacturer / (Proprietary name + Initial date, diary stringent s
Dosage Form + regulatory
Applicant Fee including agencies
Strength)
differential fee
Composition Me-too status
Demanded Price /
Pharmacological Group Pack size GMP status as
depicted in
Finished product inspection
Specification report (dated)
206. M/s CCL Tablet Nitox 500mg Form 5 with fee Rs FDA approved Approved.
Pharmaceuticals 20,000/- vide Dy. # Alinia- Romark Photocopy
(Pvt.) Ltd, 62- Each film coated tablet nil dated 19-04- fee
Industrial contains:- 2013 Nitazide-Helix challanswill
Estate, Kot Nitazoxanide 500mg (Photocopy) be verified
Lakhpat, Inspection
by Budget
Lahore Antidiarreal / report dated
antiprotozoal Pack size of SRO 11-03-2015 & Accounts
Priority # 2263 Specifications:- Division
Manufacture and
Chairman
Registration
Board will
permit
issuance of
registration
letter.
207. M/s CCL Tablet velamer 800mg Form 5 with fee Rs FDA approved Approved
Pharmaceuticals 20,000/- vide Dy. # Renagel-
(Pvt.) Ltd, 62- Each film coated tablet nil dated 19-04- Genzyme
Industrial contains:- 2013
Estate, Kot Sevelamer HCl 800mg Sevela-Hilton
Lakhpat,
Lahore Non absorbed phosphate Pack size of 30’s
binder
Priority # 2261 Specifications:-
Manufacture

208. M/s CCL Nitox powder for Form 5 with fee Rs FDA approved Approved
Pharmaceuticals Suspension 20,000/- vide Dy. # Alinia- Romark
(Pvt.) Ltd, 62- nil dated 19-04-
Industrial Each 5ml of reconstituted 2013 Nitazide-Helix
Estate, Kot suspension contains:-
Lakhpat, Nitazoxanide 100mg
Lahore Pack size of 30ml
Antidiarrheal /
Priority # 2264 antiprotozoal
Specifications:-
Manufacture
209. M/s Sami Cynfo 1g IV Injection 31-10-2011 Proof of Deferred for

Pharmaceuticals Dy.No.283 approval confirmatio
(Pvt.) Ltd, F-95, Each combination pack Rs.8000/- Firm is GMP
Rs.l2,000/-
status of n of
Off. Hub River contains: compliant as same approval
31-07-2013
Road, S.I.T.E, Sterile powder of per inspection dosage form status by
fosfomycin sodium eq. to (Photocopy)
Karachi dated 03-11- in reference reference
Fosfomycin..1g 2015
Priority # 1467 Water for injection …10 countries regulatory
Rs. 110/- per vial and authorities
Swapped ml
Pakistan not and
(Anti biotic) provided. Pakistan
and fee
challan
210. M/s Sami Capsule Colcin 8mg 21-03-2012 The Deferred for
Pharmaceuticals Dy.No.644 proposed confirmatio
(Pvt.) Ltd, F-95, Each capsule contains Form 5 Firm is GMP
Rs.8000/-
dosage form n of
Off. Hub River Thiocolchicoside IP 8mg compliant as doesn’t approval
Rs.l2,000/-
Road, S.I.T.E, per inspection exist in status by
31-07-2013
Karachi Muscle relaxant dated 03-11-
(Photocopy) Pakistan reference
Manufacture 2015
Pack size of and regulatory
Priority # 1486 Specification
10’s  Rs. 300/- reference authorities
Swapped
20s  Rs. 600/- countries. and
Pakistan
and fee
challan
211. M/s Sami Capsule Colcin 4mg 21-03-2012 Muscoril – Approved.
Pharmaceuticals Dy.No.647 Sanofi, France Photocopy
(Pvt.) Ltd, F-95, Each capsule contains Form 5
Rs.8000/-
fee
Off. Hub River Thiocolchicoside IP 4mg Muscoril - challanswill
Rs.l2,000/-
Road, S.I.T.E, Searle
31-07-2013 be verified
Karachi Muscle relaxant
(Photocopy) by Budget
Manufacture Firm is GMP
Priority # 1487 Specification & Accounts
Pack size & priec compliant as
Swapped Division
as per SRO per inspection
and
dated 03-11-
Chairman
2015
Registration

Board will
permit
issuance of
registration
letter
212. M/s Sami Injection Colcin 4mg/2ml 21-03-2012 Muscoril – Deferred for
Pharmaceuticals Dy.No.654 Sanofi, France clarification
(Pvt.) Ltd, F-95, Each 2ml ampoule Form 5
Rs.8000/-
of master
Off. Hub River contains Muscoril - formulation
Rs.l2,000/-
Road, S.I.T.E, Thiocolchicoside IP 4mg Searle and role of
31-07-2013
Karachi Sodium chloride 16.8mg
(Photocopy) sodium
Priority # 1489 Muscle relaxant Firm is GMP chloride
Pack size of either active
Swapped Manufacture compliant as
ampoule & price as or inactive
Specification per inspection
per SRO ingredient
dated 03-11-
2015 and fee
challan
213. M/s Sami Colcin 0.25% Ointment 06-04-2012 The Deferred for
Pharmaceuticals Dy.No.676 proposed confirmatio
(Pvt.) Ltd, F-95, Each gram contains Form 5 Firm is GMP
Rs.8000/-
dosage form n of
Off. Hub River Thiocolchicoside IP compliant as doesn’t approval
Rs.l2,000/-
Road, S.I.T.E, 2.5mg per inspection
31-07-2013 exist in status by
Karachi dated 03-11-
(Photocopy) Pakistan reference
Muscle relaxant 2015
Priority # 1488 Manufacture and regulatory
Pack size of 30gm reference authorities
Swapped Specification
tube  Rs. 280/- countries. and
Pakistan
and fee
challen.
214. M/s Sami Tablet Esylate 500mg 29-08-2011 Dicynene Approved.
Pharmaceuticals Dy # 1127 Form 5 500mg – Photocopy
(Pvt.) Ltd, F-95, Each tablet contains Rs. 8000/- Sanofi France
Rs.12,000/- 31-07-
fee
Off. Hub River Etamsylate BP 500mg challanswill
Road, S.I.T.E, 2013 (Photocopy) Cytoplex – be verified
Karachi Hemostatic agent AGP Reg#
by Budget
Manufacture 061420
Priority # 1806 Specification Pack size & price & Accounts
swapped as per PRC Division
Firm is GMP and
compliant as Chairman
per inspection Registration
dated 03-11- Board will
2015 permit
issuance of
registration
letter

215. M/s Sami Injection Esylate 13-06-2012 Proof of Deferred for
Pharmaceuticals 125mg/ml Dy # 1671, Form 5 approval confirmatio
(Pvt.) Ltd, F-95, Rs.20,000/-
status of n of
Off. Hub River Each ml contains (Photocopy) Firm is GMP same approval
Road, S.I.T.E, Etamsylate BP 125mg compliant as dosage form status by
Karachi per inspection
Pack size of in reference reference
Hemostatic agent dated 03-11-
Priority # 1524 Manufacture 6s  Rs. 120/- countries regulatory
2015 not authorities
swapped Specification
provided. and
Pakistan
and fee
challan.
216. M/s Sami Injection Esylate 13-06-2012 A product of Approved.
Pharmaceuticals 250mg/2ml Dy # 1126, Form 5 OM Pharma - Photocopy
(Pvt.) Ltd, F-95, Rs.8,000/- Switzerland
Rs. 12000/-
fee
Off. Hub River Each 2ml contains challanswill
31-07-2013
Road, S.I.T.E, Etamsylate BP 250mg Cytoplex – be verified
(Photocopy) AGP Reg #
Karachi
by Budget
Hemostatic agent 061419
Priority # 1521 Manufacture & Accounts
Pack size & price Division
swapped Specification Firm is GMP
as per SRO and
compliant as
per inspection Chairman
dated 03-11- Registration
2015 Board will
permit
issuance of
registration
letter
217. M/s Sami Tablet Viptin-Met 50/500 18-071-2012 TGA approved Approved.
Pharmaceuticals Dy.No.1329 Form 5 Galvumet – Photocopy
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/- Novartis
Rs.l2,000/-
fee
Off. Hub River contains challanswill
31-07-2013
Road, S.I.T.E, Vildagliptin MS 50mg Galvusmet - be verified
Metformin HCl BP (Photocopy) Novartis
Karachi
by Budget
500mg
Pack size & price & Accounts
Priority # 836 Firm is GMP
as per SRO Division
swapped Anti-diabetic compliant as
Manufacture per inspection and
Specification dated 03-11- Chairman
2015 Registration
Board will
permit
issuance of
registration
letter

218. M/s Sami Tablet Neo-Moor 50mg 03-10-2011 TGA approved Approved.
Pharmaceuticals Dy.No.235 Form 5 Pristiq – Pfizer. Photocopy
(Pvt.) Ltd, F-95, Each extended release Rs.8000/-
Rs.l2,000/-
fee
Off. Hub River film coated tablet Lafaxine - challanswill
31-07-2013
Road, S.I.T.E, contains Genix be verified
Desvenlafaxine (as (Photocopy)
Karachi
by Budget
succinate monohydrate) Firm is GMP
Priority # 1421 50mg compliant as
as per SRO Division
swapped per inspection
Anti-depressant and
dated 03-11-
Manufacture Chairman
2015
Specification Registration
Board will
permit
issuance of
registration
letter
219. M/s Sami Tablet Neo-Moor 100mg 03-10-2011 FDA approved Approved.
Pharmaceuticals Dy.No.234 Form 5 Pristiq – Wyeth Photocopy
(Pvt.) Ltd, F-95, Each extended release Rs.8000/-
Rs.l2,000/-
fee
Off. Hub River film coated tablet Lafaxine - challanswill
31-07-2013
Road, S.I.T.E, contains Genix be verified
(Photocopy)
Karachi Desvenlafaxine (as
by Budget
succinate monohydrate) Firm is GMP
Priority # 1469 100mg compliant as
as per SRO Division
swapped per inspection
Anti-depressant and
dated 03-11-
Manufacture Chairman
2015
Specification Registration
Board will
permit
issuance of
registration
letter
220. M/s Sami Tablet ULIP 30mg 23-09-2011 MHRA Approved.
Pharmaceuticals Dy.No.196 Form 5 approved Photocopy
(Pvt.) Ltd, F-95, Each tablet contains Rs.8000/- ellaOne-HRA
Rs.l2,000/-
fee
Off. Hub River Ulipristal Acetate 30mg challanswill
31-07-2013
Road, S.I.T.E, Elcat – Genix be verified
(Photocopy)
Karachi Synthetic Progesterone –
by Budget
Contraceptive Hormonal
Pack size & Accounts
Priority # 1422 Manufacture section of the
5s  Rs. 500/- Division
swapped Specification firm is GMP
and
compliant as
Chairman
per inspection
Registration
dated 03-11-
Board will
2015
permit
issuance of

registration
letter
221. M/s Sami Tablet Eriva 0.5 mg 23-09-2011 MHRA Approved.

Pharmaceuticals Dy.No.196 Form 5 approved Photocopy
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/- Baraclude –
Rs.l2,000/-
fee
Off. Hub River contains Bristol challanswill
31-07-2013
Road, S.I.T.E, Entecavir monohydrate be verified
eq to entecavir 0.5 mg (Photocopy) BVIR-Bosch
Karachi
by Budget
Priority # 1595 Anti-viral Firm is GMP
5s  Rs. 500/- Division
swapped Manufacture compliant as
Specification per inspection and
dated 03-11- Chairman
2015 Registration
Board will
permit
issuance of
registration
letter
222. M/s Sami Tablet Viptin 50mg 18-07-2012 MHRA Approved.
Pharmaceuticals Dy # 1331 Form 5 approved Photocopy
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/- Galvus – fee
Off. Hub River contains Rs.12,000/- Novartis challanswill
Road, S.I.T.E, Vildagliptin MS 50mg 31-07-2013
be verified
Karachi (Photocopy) Galvus
by Budget
Anti-Diabetic
Priority # 802 Manufacture Pack size  as per Firm is GMP & Accounts
swapped Specification SRO compliant as Division
per inspection and
dated 03-11- Chairman
2015 Registration
Board will
permit
issuance of
registration
letter
223. M/s Sami Mofest infusion 400mg 25-01-2011 Moxibar – Proof of In proposed
Pharmaceuticals /100ml Dy.No.380 Form 5 B&H approval of strength of
(Pvt.) Ltd, F-95, Rs.8000/-
Rs.l2,000/-
same moxifloxaci
Off. Hub River Each 100ml contains Firm is GMP strength in n
31-07-2013
Road, S.I.T.E, Moxifloxacin 400mg compliant as
(Photocopy) reference 400mg/100
Karachi per inspection countries. ml, it has
Antibiotics dated 03-11-
Pack size 100ml as been
Priority # 1805 Manufacture 2015
per SRO observed
Specification
that
crystallizati
on occurs

and product
is not
stable.
The Board
directed
firm to
follow
innovator
brand’s
formulation
i.e.
Moxifloxaci
n
400mg/250
ml and
submit
revised
Form 5.
224. M/s Sami Novoteph Insta Sachet 31-12-2010 Proof of Deferred for
Pharmaceuticals 40/1680 Dy.No.2275 approval confirmatio
(Pvt.) Ltd, F-95, Rs.8000/- Firm is GMP
Rs.l2,000/-
status of n of
Off. Hub River Each sachet contains compliant as same approval
31-07-2013
Road, S.I.T.E, Esomeprazole per inspection dosage form status by
Magnesium Trihydrate (Photocopy)
Karachi dated 03-11- in reference reference
USP eq to Esomeprazole
Pack size 14s  2015 countries regulatory
Priority # 746 40mg
Rs. 1825/- not authorities
Sodium carbonate BP
1680mg provided. and
Pakistan
PPI-anti ulcer and fee
Manufacture challan.
Specification
225. M/s Sami Tablet Mefloq-plus 25-03-2013 The Deferred for
Pharmaceuticals 220/100 Dy.No.181 proposed confirmatio
(Pvt.) Ltd, F-95, Rs.20,000/- Firm is GMP formulation n of
Off. Hub River Each tablet contains compliant as doesn’t approval
Road, S.I.T.E, Mefloquine HCl eq to Pack size
per inspection exist in status by
Karachi Mefloquine BP 220mg 3s  Rs. 360/-
6s  Rs. 720/- dated 03-11- reference reference
Artesunate MS 100mg
2015 countries regulatory
Priority # 1791
Anti malarial and authorities /
Manufacture Pakistan. WHO and
Specification Pakistan.

226. M/s Sami Tablet GPRIDE-M 1/500 20-01-2012 Proof of Deferred for
Pharmaceuticals Dy.No.474 Form 5 approval confirmatio
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/-
Rs.l2,000/-
status of n of
Off. Hub River contains Firm is GMP same approval
31-07-2013
Road, S.I.T.E, Glimepiride USP 1mg compliant as dosage form status by
Metformin HCl BP (Photocopy)
Karachi per inspection
Pack size & price in reference reference
500mg dated 03-11-
as per SRO countries regulatory
Priority # 1040 2015
swapped Anti-diabetic not authorities
Manufacture provided. and
Specification Pakistan
and fee
challan.
227. M/s Sami Tablet GPRIDE-M 2/500 20-01-2012 Proof of Deferred for
Pharmaceuticals Dy.No.475 Form 5 approval confirmatio
(Pvt.) Ltd, F-95, Each film coated tablet Rs.8000/- Hipride –
Rs.l2,000/-
status of n of
Off. Hub River contains Hilton same approval
31-07-2013
Road, S.I.T.E, Glimepiride USP 2mg dosage form status by
Metformin HCl BP (Photocopy)
Karachi Firm is GMP in reference reference
Pack size & price
500mg compliant as
as per SRO countries regulatory
Priority # 1041 per inspection
swapped Anti-diabetic not authorities
dated 03-11- provided. and fee
Manufacture 2015
Specification challan
228. M/s Sami Tablet GPRIDE-M 20-01-2012 Proof of Deferred for
Pharmaceuticals 2/1000 Dy.No.475 Form 5 approval confirmatio
(Pvt.) Ltd, F-95, Rs.8000/- Hipride –
Rs.l2,000/-
status of n of
Off. Hub River Each film coated tablet Hilton same approval
31-07-2013
Road, S.I.T.E, contains
(Photocopy) dosage form status by
Karachi Glimepiride USP 2mg Firm is GMP
Metformin HCl BP compliant as
10’s  Rs. 300/- countries regulatory
Priority # 1084 1000mg per inspection
20s  Rs. 600/- not authorities
swapped dated 03-11-
Anti-diabetic provided. and fee
2015 challan.
Manufacture
Specification
229. M/s Sami Atpro Pedriatric 22-10-2012 Proof of Deferred for
Pharmaceuticals Suspension Dy # 1669 Form 5 approval confirmatio
(Pvt.) Ltd, F-95, Rs.20,000/-
status of n of
Off. Hub River Each 5ml of reconstituted (Photocopy) Firm is GMP same approval
Road, S.I.T.E, suspension contains compliant as dosage form status by
Karachi Atovaquone USP 125mg per inspection
Proguanil HCl BP 50mg dated 03-11-
Priority # 1793 30ml  Rs. 1200/- countries & regulatory
2015 Pakistan not authorities /
swapped Anti-Malarial
Manufacture provided. WHO and
and fee
challan.

230. M/s Sami Atpro Pedriatric tablet 29-08-2011 Proof of Deferred for
Pharmaceuticals Dy # 95 Form 5 approval confirmatio
(Pvt.) Ltd, F-95, Each tablet contains Rs.8,000/-
Rs. 12000/-
status of n of
Off. Hub River Atovaquone USP 125mg Firm is GMP same approval
31-07-2013
Road, S.I.T.E, Proguanil HCl BP 50mg compliant as dosage form status by
(Photocopy)
Karachi per inspection in reference reference
Anti-Malarial dated 03-11-
Priority # 1793 Manufacture countries & regulatory
Pack size of 2015 Pakistan not authorities /
6s, 12s & 30s as provided. WHO and
per SRO Pakistan
and fee
challan.
231. M/s Sami Atpro Pedriatric Tablet 29-08-2011 Proof of Deferred for
(Pvt.) Ltd, F-95, Each tablet contains Rs. 8000/-
Rs.12,000/- 31-07-
status of n of
Off. Hub River Atovaquone USP 187mg Firm is GMP same approval
Road, S.I.T.E, Proguanil HCl BP 75mg 2013 (Photocopy)
compliant as dosage form status by
Karachi per inspection in reference reference
Anti-Malarial dated 03-11-
Priority # 1806 Manufacture Pack size of countries & regulatory
6s, 12s & 30s 2015 Pakistan not authorities /
Per tablet  Rs. provided. WHO and
522.50/- Pakistan
and fee
challan.
232. M/s Sami Atpro DS Pedriatric 22-10-2012 Proof of Deferred for
Pharmaceuticals Suspension Dy # 1671, Form 5 approval confirmatio
(Pvt.) Ltd, F-95, Rs.20,000/-
status of n of
Off. Hub River Each 5ml of reconstituted (Photocopy) Firm is GMP same approval
Road, S.I.T.E, suspension contains compliant as dosage form status by
Karachi Atovaquone USP 250mg per inspection
Proguanil HCl BP 100mg dated 03-11-
Priority # 1792 30ml  Rs. 2000/- countries & regulatory
2015 Pakistan not authorities /
swapped Anti-Malarial
Manufacture provided. WHO and
and fee
challan.
233. M/s Sami Tablet Dofyl 400 mg 26-12-2012 Proof of Deferred for
(Pvt.) Ltd, F-95, Each tablet contains Rs. 20000 Firm is GMP status of n of
Off. Hub River Doxofylline MS 400 mg (Photocopy) compliant as same approval
Road, S.I.T.E, per inspection formulation status by
Karachi Bronchodilator dated 03-11-
Pack size & price in proposed reference
Manufacture 2015
Priority # 1727 Specification as per PRC strength in regulatory
swapped reference authorities /
regulatory WHO and
authorities Pakistan

not and fee
provided. challan.
234. M/s Sami Dofyl 100mg/5ml Syrup 26-12-2012 Broxane - Opal Proof of Deferred for
Pharmaceuticals Dy # 1812, Form 5 approval confirmatio
(Pvt.) Ltd, F-95, Each 5ml contains Rs.20,000/-
status of n of
Off. Hub River Doxofylline MS 100mg (Photocopy) Firm is GMP same approval
Road, S.I.T.E, compliant as formulation status by
Karachi Bronchodilator per inspection
Manufacture Pack size & price in proposed reference
as per SRO dated 03-11- strength in regulatory
2015 reference authorities
swapped
regulatory and fee
authorities challan
not
provided.
235. M/s PharmEvo Tablet IRMAX 100/10 25-04-2013 Aimix – Stability Deferred for
(Private) Dy.No.1656 Form 5- Dainnpon data proof of
Limited, A-29, Each film coated tablet D Sumitomo
Rs.50,000/-
required as approval
North Western contains Pharma, Japan per status of
Industrial Zone, Ibresartan 100mg guidelines same
Port Qasim, Amlodipine Besylate Pack size Firm is GMP
Karachi 13.87mg eq to 10s  Rs. 445/- provided in formulation
compliant as 251st
Amlodipine 10mg 14s  Rs. 623/- RB in reference
28S  Rs. 1246/- per inspection meeting. countries
Priority # 2539 dated 03-11-
Anti-hypertensive and
2015 Pakistan.
Manufacture
Specification
236. M/s PharmEvo Tablet IRMAX 150/5 25-04-2013 Proof of Deferred for
(Private) Dy.No.1656 Form 5- Firm is GMP approval confirmatio
Limited, A-29, Each film coated tablet D
compliant as status of n of
North Western contains Rs.50,000/-
per inspection same approval
Industrial Zone, Ibresartan 100mg dated 03-11- formulation status by
Port Qasim, Amlodipine Besylate 6.93 Pack size 2015
Karachi mg eq to Amlodipine 10s  Rs. 490/- in proposed reference
5mg 14s  Rs. 686/- strength in regulatory
Priority # 2535 28S  Rs. 1372/- reference authorities
Anti-hypertensive regulatory and
Manufacture authorities Pakistan.
Specification not
provided.

Port Qasim, Amlodipine Besylate Pack size
10s  Rs. 510/- 2015 in proposed reference
Karachi 13.87 mg eq to
Amlodipine 10mg 14s  Rs. 714/- strength in regulatory
Specification not
provided.
Port Qasim, Amlodipine Besylate 6.93 Pack size 2015
Karachi mg eq to Amlodipine 10s  Rs. 800/- in proposed reference
5mg 14s  Rs. 1120/- strength in regulatory
Specification not
provided.
Port Qasim, Amlodipine Besylate Pack size
10s  Rs. 820/- 2015 in proposed reference
Karachi 13.87 mg eq to
Amlodipine 10mg 14s  Rs. 1148/- strength in regulatory
Specification not
provided.
240. M/s PharmEvo Tablet Inosita plus 50/850 25-04-2013 TGA approved Approved
(Private) Dy.No.266 Form 5 Janumet –
Limited, A-29, Each film coated tablet Rs.20,000/- Merck
North Western contains Australia
Industrial Zone, Sitagliptin (as phosphate Pack size 10s 
Port Qasim, monohydrate)50mg Rs. 1100/- Janumet -MSD
Karachi Metformin HCl 850mg
Firm is GMP
Priority # 2266 PPI-anti ulcer compliant as
Manufacture per inspection
Specification dated 03-11-

2015
241. M/s PharmEvo Tablet Infixa 2.5mg 29-08-2013 MHRA Proof of Deferred for
(Private) Dy.No.1659 Form 5- approved approval provision of
Limited, A-29, Each film coated tablet D Xarelto –
Rs.50,000/-
status of stability
North Western contains Bayer same data as per
Industrial Zone, Rivaroxiban 2.5mg (Photocopy)
dosage form guidelines
Port Qasim, Firm is GMP in Pakistan provided by
Karachi Factor Xa Inhibitor Pack size
compliant as
Manufacture 7s  Rs. 1050/- not the Board
10s  Rs. 1550/- per inspection provided. IN 251st
14s  Rs. 2100/- dated 03-11- meeting and
2015 fee challan.
242. M/s PharmEvo Tablet Infixa 5mg 29-08-2013 Proof of Deferred for
(Private) Dy.No.832 Form 5-D Firm is GMP approval confirmatio
Limited, A-29, Each film coated tablet Rs.50,000/-
North Western contains (Photocopy)
Industrial Zone, Rivaroxiban 5mg dated 03-11- dosage form status by
Port Qasim, Pack size
Factor Xa Inhibitor 7s  Rs. 2100/- 2015 in reference reference
Karachi
Manufacture 10s  Rs. 3000/- countries regulatory
Priority # 2536 Specification 14s  Rs. 4200/- and authorities
Pakistan. and
Pakistan
and fee
challan.
243. M/s PharmEvo Tablet IRMAX 100/5 25-04-2013 Aimix – Stability Deferred for
(Private) Dy.No.1660 Form 5- Dainnpon data submission
Limited, A-29, Each film coated tablet D Sumitomo
Rs.50,000/-
required as of stability
North Western contains Pharma, Japan per data
Industrial Zone, Ibresartan 100mg guidelines required as
Port Qasim, Amlodipine Besylate Pack size Firm is GMP
Karachi 6.93mg eq to Amlodipine 10s  Rs. 425/- provided in per
compliant as 251st
5mg 14s  Rs. 595/- RB guidelines
28S  Rs. 1190/- per inspection meeting. provided in
Priority # 2535 dated 03-11-
Anti-hypertensive 251st RB
2015 meeting.
Manufacture
Specification

244. M/s Unison Tablet Cyclocam 20mg 04-10-2010 Marketing Approved.
Chemical worls, Dy.No.266 Form 5 authorization to Photocopy
15KM Raiwind Each tablet contains Rs.8,000/- Chiesi –UK
02-12-2013
fee
Road, Lahore Piroxicam beta dextrin and challanswill
Rs. 12000/-
191.2mg eq to Piroxicam manufactured be verified
20mg (Photocopy) by Chiesi Italy.
Priority # 403
by Budget
Pack size 2 x 10  & Accounts
NSAID Brexin – Chiesi
as per SRO Division
USP Specification
Firm is GMP and
compliant as Chairman
per inspection Registration
report. Board will
permit
issuance of
registration
letter
245. M/s Highnoon Tablet Niacol XR 04-03-2011 FDA approved Firm Approved
Laboratories 1000mg Dy.No.3189 Form 5- Niaspan – Kos previously
Limited, 17.5 D Pharmaceutical
Rs.15,000/-
applied on
km, Multan Each extended released s Form 5-D
Rs. 35000/-
Road, Lahore tablet contains but now
30-07-2013
Niacin 1000mg Dy # nil dated 30-07- Niaspan -
product is
Priority # 2299 2013 Merck
swapped Anti-hyperlipidemia being
USP Specification Firm is GMP registered in
Pack size
Pakistan.
7s  Rs. 560/- compliant as
10s  Rs. 800/- per inspection
dated 09-03-
2015
246. M/s Highnoon Tablet Niacol XR 500mg 01-03-2011 FDA approved Firm Approved
Laboratories Dy.No.3189 Form 5- Niaspan – Kos previously
Limited, 17.5 Each extended released D Pharmaceutical
Rs.15,000/-
applied on
km, Multan tablet contains s Form 5-D
Rs.35000/-
Road, Lahore Niacin 500mg but now
30-07-2013
Dy # nil dated 30-07- Niaspan -
product is
Priority # 2300 Anti-hyperlipidemia 2013 Merck
swapped USP Specification being
Firm is GMP registered in
Pack size
Pakistan.
7s  PRC compliant as
10s  PRC per inspection
dated 09-03-
2015

247. M/s Highnoon Tablet Niacol XR 750mg 01-03-2011 FDA approved Firm Approved
Laboratories Dy.No.3189 Form 5- Niaspan – Kos previously
Limited, 17.5 Each extended released D Pharmaceutical
Rs.15,000/-
applied on
km, Multan tablet contains s Form 5-D
Rs.35000/-
Road, Lahore Niacin 750mg but now
30-07-2013
Dy # nil dated 30-07- Niaspan -
product is
Priority # 2300 Anti-hyperlipidemia 2013 Merck
swapped USP Specification being
Firm is GMP registered in
Pack size
Pakistan.
7s  PRC compliant as
10s  PRC per inspection
dated 09-03-
2015
248. M/s MBL Tablet Melidone 10mg 16-04-2012 MHRA Approved

Pharma, Plot # Dy.No.722 Form 5 approved with black
B-77/A, Hub Each film coated tablet Rs.8000/- Motillium - box
Industrial contains (Photocopy) Zentiva warning.
Trading Estate Domperidone 10mg Photocopy
Rs.12,000/-
Balauchistan. Domotin -
05-08-2013 fee
Dopamine blocking agent Benson
Priority # 1533 / antiemetic challanswill
Pack size 5 x 10  be verified
BP Specification Firm is GMP
as per SRO by Budget
compliant as
per inspection & Accounts
report dated Division
02-05-2016 and
Chairman
Registration
Board will
permit
issuance of
registration
letter
249. M/s MBL Tablet Astin 40/240 17-02-2011 WHO Approved.
Pharma, Plot # Dy.No.492 Form 5 recommended Photocopy
B-77/A, Hub Each tablet contains Rs.8000/- formulation fee
Industrial Artemether 40mg (Photocopy)
Rs.12,000/- challanswill
Trading Estate Lumefantrine 240mg Amalar - be verified
05-08-2013
Balauchistan. Bloom
by Budget
Antimalarial
Pack size 8s & 16s & Accounts
Priority # 871 Manufacture Firm is GMP
 as per SRO Division
Specification compliant as
per inspection and
report dated Chairman
02-05-2016 Registration
Board will
permit
issuance of

registration
letter
250. M/s MBL Fasid Cream 15gm 27-04-2012 MHRA Approved
Pharma, Plot # Dy.No.753 approved with change
B-77/A, Hub Each gram contains Rs.8000/- Fusidin - Leo
Photocopy
of brand
Industrial Fusidic Acid 20mg name.
Rs.12,000/-
Trading Estate Sidic - Epoch Photocopy
05-08-2013
Balauchistan. Antibiotics
fee
BP Specification Firm is GMP
Priority # 1569 challanswill
Pack size of 15gm compliant as
be verified
by Budget
report dated
& Accounts
02-05-2016
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
251. M/s MBL Mb Din suspension 60ml 19-02-2011 FDA approved Approved.
Pharma, Plot # Dy.No.505-A brand Photocopy
B-77/A, Hub Each 5ml of reconstituted Rs.8000/-
Photocopy
fee
Industrial suspension contains Velosef challanswill
Rs.12,000/-
Trading Estate Cephradine USP 250mg be verified
05-08-2013
Balauchistan. Firm is GMP by Budget
Antibiotics compliant as
Pack size of 60ml & Accounts
Priority # 875 USP Specification per inspection
as per SRO Division
report dated and
02-05-2016 Chairman
Registration
Board will
permit
issuance of
registration
letter
252. M/s MBL Viospan DS suspension 27-04-2012 FDA approved Approved.
Pharma, Plot # 30ml Dy.No.750 brand Suprax - Photocopy
B-77/A, Hub Rs.8000/- Lupin
Photocopy
fee
Industrial Each 5ml of reconstituted challanswill
Rs.12,000/-
Trading Estate suspension contains Caricef - Sami be verified
05-08-2013
Balauchistan. Cefixime (as trihydrate)
by Budget
200mg Firm is GMP
Priority # 1549 & Accounts
Pack size of 30ml compliant as
Antibiotics Division
USP Specification and

Board will
permit
issuance of
registration
letter
253. M/s Pliva Tablet Diamet 17-02-2011 Proof of Deferred for

Pakistan (Pvt.) Dy.No.487 approval confirmatio
Ltd, Plot # B-77, Each tablet contains Rs.8000/-
Photocopy
status of n of
Hub Industrial Glucosamine Sulphate Firm is GMP same approval
Rs.12,000/-
Trading Estate, USP 500mg compliant as
19-9-2013 dosage form status by
Balauchistan. Chondroitin Sulphate per inspection
USP 400mg
in reference reference
Pack size report dated countries. regulatory
Priority # 862
2 x 10s  Rs. 02-05-2016 authorities
Dietary supplement
320/- Pack of and
USP Specification
locally Pakistan
registered and fee
brand. challan.
254. M/s Pliva Tablet Meelas 5mg 17-02-2011 MHRA Approved.
Pakistan (Pvt.) Dy.No.486 Form 5 approved Photocopy
Ltd, Plot # B-77, Each chewable tablet Rs.8000/- Singlulair –
(Photocopy)
fee
Hub Industrial contains Merck,UK challanswill
Rs.12,000/-
Trading Estate, Montelukast Sodium USP be verified
19-9-2013
Balauchistan. equivalent to Montelukast Amisped -
by Budget
5mg Sanofi
Priority # 864 10s  Rs. 170/-
Bronchodilators Firm is GMP Division
14s  Rs. 240/- and
USP Specification compliant as
per inspection Chairman
report dated Registration
02-05-2016 Board will
permit
issuance of
registration
letter
255. M/s Pliva Tablet Meelas 10mg 17-02-2011 MHRA Approved.
Pakistan (Pvt.) Dy.No.485 approved branf Photocopy
Ltd, Plot # B-77, Each film coated tablet Rs.8000/- of Accord
(Photocopy)
fee
Hub Industrial contains challanswill
Rs.12,000/-
Trading Estate, Montelukast Sodium USP Asfree- be verified
19-9-2013
Balauchistan. equivalent to Montelukast Medisure
by Budget
10mg
Priority # 863 10s  Rs. 190/- Firm is GMP
Bronchodilators compliant as Division
14s  Rs. 310/- and
USP Specification per inspection

Board will
permit
issuance of
registration
letter
256. M/s MBL Fomatin Suspension 60ml 10-05-2012 i. Applicant Deferred as

Pharma, Plot # Dy.No.859 Firm is GMP s shall per decision
B-77/A, Hub Each 5ml contains Rs.8000/- revise of 250th RB
compliant as
Industrial Famotidine 10mg Photocopy their meeting as
Rs.12,000/- per inspection
Trading Estate report dated formulati under:-
05-08-2013
Balauchistan. Anti ulcer 02-05-2016 on as per i. Applica
USP Specification innovator nts shall
Pack size as per
Priority # 1570 (new revise
SRO
registrati their
on formula
applicatio tion as
n with per
complete innovat
fee) or (new
within six registrat
months if ion
manufact applicat
uring ion with
facility is complet
approved e fee)
by CLB. within
ii. For six
already months
registered if
drugs, manufa
same cturing
procedur facility
e as is
mentione approve
d above d by
(at Sr. CLB.
No. i) ii. For
shall be already
adopted. registered
Otherwis drugs,
e show same
cause procedur
notice e as
shall be mentione
issued for d above
de- (at Sr.

registrati No. i)
on of shall be
registered adopted.
drugs in Otherwis
this e show
formulati cause
on. notice
iii. All such shall be
applicatio issued for
n shall be de-
processed registrati
on on of
priority registered
basis. drugs in
this
formulati
on.
iii. All such
applicatio
n shall be
processed
on
priority
basis.
257. M/s MBL Vanax Suspension 60ml 10-05-2012 Dexib –Tabros Proof of Deferred for
Pharma, Plot # Dy.No.857 approval confirmatio
B-77/A, Hub Each 5ml contains Rs.8000/- Firm is GMP
Photocopy
status of n of
Industrial Dexibuprofen 100mg compliant as same approval
Rs.12,000/-
Trading Estate per inspection dosage form status by
05-08-2013
Balauchistan. NSAID report dated in reference reference
Manufacture
Pack size as per 02-05-2016 countries. regulatory
SRO authorities
and fee
challan.
258. M/s MBL Kanz Dry Powder 27-04-2012 Novidat - Sami Proof of Deferred for
Pharma, Plot # Suspension Dy.No.753 approval  Proof of
B-77/A, Hub Rs.8000/- Firm is GMP
Photocopy
status of approval
Industrial Each 5ml of reconstituted compliant as same status of
Rs.12,000/-
Trading Estate suspension contains per inspection dosage form
05-08-2013 same
Balauchistan. Ciprofloxacin HCl.2H2O report dated in reference dosage
eq to Ciprofloxacin 02-05-2016
Priority # 1547 250mg countries. form in
Pack size of 60ml referenc
as per SRO Product is
Antibiotics e
Manufacture under countrie
Specification review as s.
innovator  Product
brand is in is under

base form review
of active as
ingredient innovato
while firm r brand
has applied is in
as salt form. base
form of
active
ingredie
nt while
firm has
applied
as salt
form.
 Fee
challan
259. M/s Asian Artim Plus Suspension 21-05-2012 WHO Approved

Continental Dy.No.955 recommended with change
(Pvt.) Ltd, D-32, Each 5ml of reconstituted Rs.8000/- formulation
Rs.12,000/-
of brand
S.I.T.E, Super suspension contains name.
05-09-2013
Highway, Artemether 15mg Artem -Hilton Photocopy
Lumefantrine 90mg (Photocopy)
Karachi.
fee
Firm is GMP
Priority # 1630 Antimalarial challanswill
Pack size 30ml x compliant as
Manufacture be verified
60ml  as per per inspection
Specification by Budget
SRO report dated
& Accounts
11-11-2015
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
260. M/s Asian Injection Vitadol 5mg 17-05-2012 Vit D3 B.O.N, Approved.
Continental Dy.No.884 France Photocopy
(Pvt.) Ltd, D-32, Each 1ml ampoule Rs.8000/-
Rs.12,000/-
fee
S.I.T.E, Super contains Indrop-D , challanswill
05-09-2013
Highway, Cholecalciferol (Vit. D3) Neutro be verified
5mg (Photocopy)
Karachi.
by Budget
Firm is GMP
Priority # 1593 Vitamin & Accounts
Pack size 30ml x compliant as
USP Specification Division
60ml  as per per inspection
and
SRO report dated

11-11-2015 Chairman
Registration
Board will
permit
issuance of
registration
letter
261. M/s Atco Afantrine DS Dry 16-02-2012 WHO Approved.

Laboratories Suspension Dy.No.581 recommended Photocopy
Limited, B-18, Rs.8000/- formulation
Photocopy
fee
S.I.T.E, Karachi Each 5ml of reconstituted challanswill
Rs.12,000/-
suspension contains Artem plus -
Priority # 1502 Artemether MS 30mg Hilton
Lumefantrine MS 180mg
by Budget
Pack size of 30ml & Accounts
& 60ml as per SRO Firm is GMP
Antimalarial compliant Division
Manufacture and
Specification Chairman
Registration
Board will
permit
issuance of
registration
letter
262. M/s Atco Vorinaz Powder for Oral 19-11-2012 Vfend-MHRA Firm Approved.
Laboratories suspension 1774 Form 5-D approved previously Photocopy
Limited, B-18, Rs.50,000/-
applied on fee
S.I.T.E, Karachi Each 5ml of reconstituted (Photocopy) Hongos-CCL Form 5-D challanswill
suspension contains Reg#077021 but now be verified
Priority # 1990 Voriconazole 200mg
Pack size of 30ml product is by Budget
GMP
(Triazole Anti-fungal & 60ml as per SRO compliant locally & Accounts
agent) section registered Division
Manufacture and firm has and
Specification submitted Chairman
application Registration
of Board will
prescribed permit
Form 5. issuance of
registration
letter

263. M/s Atco Tablet Xecam-P 4/500 16-02-2012 The Deferred for
Laboratories Dy.No.584 Form 5-D GMP proposed confirmatio
Limited, B-18, Each film coated tablet Rs.15000/- compliant
Rs.35,000/-
formulation n of
S.I.T.E, Karachi contains section doesn’t approval
05-08-2013
Lornoxicam MS 4mg exist in status by
Paracetamol BP 500mg (Photocopy)
Priority # 1500
reference reference
(Muscle relaxant ) countries regulatory
Pack size of 14s & and authorities
Manufacture
28s as per SRO Pakistan. and fee
Specification
challan.
264. M/s Atco Tablet Xecam-P 8/500 16-02-2012 The Deferred for
Laboratories Dy.No.584 Form 5-D GMP proposed confirmatio
Limited, B-18, Each film coated tablet Rs.15000/- compliant
Rs.35,000/-
formulation n of
S.I.T.E, Karachi contains section doesn’t approval
05-08-2013
Lornoxicam MS 8mg exist in status by
Paracetamol BP 500mg (Photocopy)
Priority # 1501
reference reference
(Muscle relaxant ) countries regulatory
Pack size of 14s & and authorities
Manufacture
28s as per SRO Pakistan. and fee
Specification
challan
265. M/s Atco Tablet Panel 10mg 29-03-2011 MHRA Stability Deferred for
Laboratories Dy.No.490 Form 5-D approved data provision of
Limited, B-18, Each film coated tablet Rs.15000/- Fycompa -
Rs.35,000/-
required as stability
S.I.T.E, Karachi contains Eisai per data
05-08-2013
Perampanel 10mg guidelines required as
Priority # 2164
provided in per
(Antiepileptic) GMP
Manufacture
Pack size of 7s, 14s
compliant 251st RB guidelines
& 28s meeting. provided in
Specification section
Per tablet  Rs. 251st RB
375/- meeting.
266. M/s Atco Tablet Alodip-H 29-03-2011 USFDA Stability Deferred for
Laboratories Dy.No.490 Form 5-D approved data provision of
Limited, B-18, Each film coated tablet Rs.15000/- Amturnide-
Rs.35,000/-
S.I.T.E, Karachi contains Novartis per data
05-08-2013
Aliskiren (as guidelines required as
Priority # 2375 hemifumarate) MS 300
provided in per
mg GMP
Amlodipine (as besylate)
Pack size of 14s &
28s as per SRO meeting. provided in
BP 5mg section
Hydrochlorthiazide BP 251st RB
12.5mg meeting.
(Cardiovascular drug )
Manufacture
Specification

267. M/s Atco Tablet Aloglip-M 24-10-2013 USFDA Stability Deferred for
Laboratories 12.5/1000 Dy.No.273 Form 5-D approved data provision of
Limited, B-18, Rs.15000/- Kazano -
Rs.35,000/-
S.I.T.E, Karachi Each film coated tablet Takeda per data
05-08-2013
contains guidelines required as
Priority # 2656 Alogliptin Benzoate MS
provided in per
eq to Alogliptin 12.5mg GMP
Metformin HCl BP
Pack size of 10s,
14s 20s & 30s as meeting. provided in
1000mg section
per SRO 251st RB
(Cardiovascular drug ) meeting.
Manufacture
Specification
268. M/s Pacific Rifin Dispersible tablet 16-11-2012 WHO -UN  To Deferred for
Pharmaceuticals Form 5 prequalified following
deposit
Limited, 30th Each dispersible tablet 20,000 formulation
(Photocopy) remainin shortcoming
km, Multan contains g fee for s
Road, Lahore Rifampicin 60mg
Pack size of prescrib  To
Isoniazid 30mg GMP
Priority # 1981 28s  Rs. 335.40/- compliant ed Form deposit
(Antimycobacterial) 56s  Rs. 670.79/- section 5-D. remainin
Manufacture  Stability g fee for
Specification studies prescrib
as per ed Form
guidelin 5-D.
es  Stability
provided studies
in 251st as per
RB guidelin
meeting. es
provided
in 251st
RB
meeting.
269. M/s Pacific Rifin Dispersible tablet 16-11-2012 WHO -UN  To Deferred for
Pharmaceuticals Form 5 prequalified deposit following
Limited, 30th Each dispersible tablet 20,000 formulation
(Photocopy) remainin shortcoming
km, Multan contains g fee for s
Road, Lahore Rifampicin 60mg
Pack size of prescrib  To
Isoniazid 60mg GMP
Priority # 1982 28s  Rs. 337.93/- compliant ed Form deposit
(Antimycobacterial) 56s  Rs. 675.86/- section 5-D. remainin
Manufacture  Stability g fee for
Specification studies prescrib
as per ed Form
guidelin 5-D.
es  Stability
provided studies
in 251st as per

RB guidelin
meeting. es
provided
in 251st
RB
meeting.
270. M/s NabiQasim Kenazol 2% Lotion 08-05-2013 To provide Deferred for

Industries Dy.No.304 Form 5 Conaz - Atco proof of confirmatio
(Private) Each ml contains: Rs.20,000/- approval of n of
Limited, 17/24, Ketoconazole… 20 mg (Photocopy) Firm is GMP same approval
Korangi compliant dosage form status by
Industrial Area, (Antifungal agent)
Manufacture Pack size of 30ml in reference reference
Korangi,
Karachi Specification & 60ml as per SRO countries. regulatory
authorities
Priority # 2294 and fee
challan.
271. M/s Surge Dexol 5% infusion 27-6-2011  To Deferred for

Laboratories Dy # 1487
provide  Primary
(Private) Each 100 ml contains: 8000/- Form 5
12000/16-01-2014 primary packagin
Limited, 10th, Dextrose Anhydrous USP packagin g details.
KM Faisalabad 5gm (5% w/v)
Road, Bikhi
g details.  Proof of
Pack size approval
District, (Carbohydrate)
100ml, 500 ml, status of
Sheikhupura. USP Specification
1000ml as per SRO same
Priority # 1545 dosage
swapped form in
same
primary
packing
by
reference
regulator
authoritie
s and
Pakistan.

272. M/s Surge Injection Alset 27-6-2011 MHRA  Me too Deferred for
Laboratories Dy # 1487 approved status  Confirm
8000/- Form 5
(Private) Each 5ml vial contains:
12000/16-01-2014
Aloxi – needs ation of
Limited, 10th, Palonosetron (as HCl) Chughai confirmat pack
KM Faisalabad 0.25mg
ion size.
Road, Bikhi
Pack size Aloxetron –  Provision of
District, (5HT3 receptor
100ml, 500 ml, Atco approval
Sheikhupura. antagonist)
1000ml as per SRO approved in status of
Manufacture
Priority # 1351 Specification 228th meeting same
swapped for improt dosage
form in
Pakistan, as
reference
mentioned
in Form 5
is not
correct.
273. M/s Surge Preslin Injection 20mg 26-4-2012  Complete Deferred for
Laboratories 8000/- Form 5
form 5 provision of
12000/16-01-2014
(Private) Each ml contains:
(Photocopy) required.  Complete
Limited, 10th, Hydralazine HCl USP
 Original form 5.
KM Faisalabad 20mg
Road, Bikhi
challan  Original
District, (Antihypertensive) Pack size of 30ml receipt challan
Sheikhupura. USP Specification & 60ml as per SRO required. receipt.
 Complete  Complete
Priority # 1202 descriptio descriptio
swapped n of n of
dosage dosage
form form.
required.  Proof of
 Commit approval
ment status of
required same
as per dosage
decision form in
st
of 251 reference
RB countires
meeting. and
 Latest Pakistan
inspectio  Commit
n report ment as
required. per
decision
of 251st
RB

meeting.
 Latest
inspection
report.
 Fee challan
274. M/s Surge Water for injection 29-8-2012  Complete Deferred for
Laboratories 8000/- Form 5
form 5 provision of
12000/16-01-2014
(Private) Water for injection 50ml
(Photocopy) required.  Complete
Limited, 10th,
 Original form 5.
KM Faisalabad (Diluent)
Road, Bikhi USP Specification challan  Original
District, Pack size of 30ml receipt challan
Sheikhupura. & 60ml as per SRO required. receipt.
 Complete  Clinical
Priority # 1853 descriptio Indicatio
n of n
dosage  Proof of
form availabilit
required. y of same
 Commit pack size
ment in
required reference
as per countires
decision and
st
of 251 Pakistan.
RB  Proof of
meeting. approval
 Latest status of
inspectio same
n report dosage
required. form in
 Indicatio reference
n of countires
dosage and
form. Pakistan
 Commit
ment as
per
decision
of 251st
RB
meeting.
 Latest
inspectio
n report.
 Intended

use.
 Fee
challan
275. M/s Surge Sunvega 39 mg injection 29-8-2012 USFDA  Complete Deferred for
Laboratories 8000/- Form 5 approved form 5-D  Complete
(Private) Each 0.25ml pre filled 12000/16-01-2014 Invega
(Photocopy) required. form 5-D.
Limited, 10th, syringe contains sustenna –
 Original  Original
KM Faisalabad Paliperidone palmitate Janssen
Road, Bikhi 39mg
challan challan
District, (Prolonged released) Pack size of 30ml receipt receipt.
Sheikhupura. & 60ml as per SRO required.  Complete
(Dopamine antagonist)  Complete descriptio
Priority # 1204 USP Specification descriptio n of
n of dosage
dosage form.
form  Commit
required. ment as
 Commit per
ment decision
required of 251st
as per RB
decision meeting.
of 251st  Latest
RB inspectio
meeting. n report
 Latest required.
inspectio  manufact
n report uring
required. facility of
 Proof of pre-filled
manufact syringes.
uring  Fee
facility of challan
pre-filled
syringes.
276. M/s Surge Sunvega 39 mg injection 29-8-2012 USFDA  Complete Deferred for
Laboratories 8000/- Form 5 approved form 5-D  Complete
(Private) Each 0.25ml pre filled 12000/16-01-2014 Invega
(Photocopy) required. form 5-D.
Limited, 10th, syringe contains sustenna –
 Original  Original
KM Faisalabad Paliperidone palmitate Janssen
Road, Bikhi 39mg challan challan
District, (Prolonged released) Pack size of 30ml receipt receipt.
Sheikhupura. & 60ml as per SRO required.  Complete
(Dopamine antagonist)  Complete descriptio
Priority # 1545 USP Specification descriptio n of
n of dosage

dosage form.
form  Commit
required. ment as
 Commit per
ment decision
required of 251st
as per RB
decision meeting.
of 251st  Latest
RB inspectio
meeting. n report.
 Latest  manufact
inspectio uring
n report facility of
required. pre-filled
 Proof of syringes.
manufact  Fee
uring challan
facility of
pre-filled
syringes.
277. M/s Venus Viofer Injection 02-12-2010 Dy # FDA approved Approved

Pharma, 23km, 4534 Venofer – with change
Multan Road, Each 5ml ampoule 8000/- Form 5 Lutipold
12000/05 -11-2013
of brand
Lahore contains name.
Iron sucrose eq to (Photocopy) Venofer – RG
Photocopy
Priority # 498 elemental iron 100mg (20
fee
mg / ml) GMP
Pack size of 30ml challanswill
compliant
& 60ml as per SRO be verified
(Hematinic) section vide
USP Specification inspection by Budget
report dated & Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter

278. M/s Venus Viofer Infusion 100 ml 02-12-2010 Dy # FDA approved Deferred for
Pharma, 23km, 4534 Venofer – confirmatio
Multan Road, Part I 8000/- Form 5 Lutipold
12000/05 -11-2013
n of
Lahore Each 5ml ampoule approval
contains (Photocopy) Venofer – RG status of
Priority # 668 Iron sucrose eq to
same
elemental iron 100mg (20 GMP
Pack size formulation
mg / ml) compliant
100ml  Rs. Rs. by refrence
Part II section vide
1000/- regulatory
Sodium Chloride 0.9% inspection
report dated authorities
(Hematinic) and
USP Specification Pakistan
and fee
challan.
279. M/s Venus Normal Saline 0.9% 02-12-2010 Dy # Proof of Deferred for
Pharma, 23km, 4534 GMP approval confirmatio
Multan Road, Each ml contains 8000/- Form 5 compliant
12000/05 -11-2013
status of n of
Lahore Sodium Chloride 9 mg section vide same approval
(Photocopy) inspection dosage form status of
Priority # 669 (Electrolyte) report dated
in glass same
USP Specification
Pack size bottle as formulation
100ml  Rs. 45/- primary in glass
container bottle as
primary
container by
refrence
regulatory
authorities
and
Pakistan
and fee
challan
280. M/s Venus Tablet Apresolin - 10 02-11-2010 FDA approved The product Deferred for
Pharma, 23km, Dy # 4207 Aspresolin – is not yet  Applicati
Multan Road, Each tablet contains 8000/- Form 5 Novartis
12000/05 -11-2013
registered in on on
Lahore Hydralazine HCl 10mg Pakistan in prescribe
(Photocopy) GMP proposed d Form 5-
Priority # 499 (Antihypertensive) compliant
strength D along
USP Specification section vide
Pack size with
inspection
1 x 50  Rs. 103/- other
report dated
legal and
codal
formalitie
s because
the
proposed

formulati
on is not
yet
registered
in
Pakistan.
 Fee
challan
281. M/s Hilton Colt Drops 125mg / 5ml Form 5 with MHRA Approved
Pharma (Pvt.) prescribed fee of Rs approved brand with change
Ltd, 13, Sector Each 5ml after 20,000 vide Dy # of Sandoz
1168 dated 03-07-
of brand
15, Korangi reconstitution contains name
2013
Industrial Area, Clarithromycin 125mg Klaricid – because
Karachi (granules for oral Abbott
proposed
suspension)
Pack size as per brand name
Priority # 2122 PRC
swapped (Antibiotics) GMP resembles
USP Specification compliant with already
section vide registered
inspection brand name.
report dated
282. M/s Hilton Tablet Maxit-Neuro Form 5 with Proof of Rejected as
Pharma (Pvt.) prescribed fee of Rs approval formulation
Ltd, 13, Sector Each film coated tablet 20,000 vide Dy # GMP
1297 dated 11-07-
status of is not
15, Korangi contains compliant same approved by
2013
Industrial Area, Diclofenac Sodium 50mg section vide dosage form reference
Karachi Thiamine(Vitamin B1) inspection
in reference regulatory
50mg report dated
Pack size as per countries authorities
Priority # 2120 Pyridoxine HCl (Vit B6)
PRC and and
swapped 50mg
Cyanocobalamin Pakistan. Pakistan.
(Vitamin B12) 250 mcg
(pain reliever)
Manufacture
Specification
283. M/s Hilton Hilto-D Sachet Form 5-D with Firm needs Deferred for
Pharma (Pvt.) prescribed fee of Rs to provide confirmatio
Ltd, 13, Sector Each Sachet contains 50,000 vide Dy #
1408 dated 19-07-
following n of
15, Korangi Vitamin D3 documents / approval
2013
Industrial Area, (Cholecalciferol) 600,000 information status of
Karachi IU GMP
for same
compliant
Pack size completion formulation
Priority # 2117 (Vitamin) section vide
30s  Rs. 900/- of / dosage
swapped Manufacture inspection
Specification report dated application. form by
 Proof of reference
approval regulatory
status of authorities.

same
dosage
form in
referenc
e
countrie
s.
284. M/s Hilton Capsule toploss 7.5/46 Form 5-D with FDA approved Firm needs Deferred of
Pharma (Pvt.) prescribed fee of Rs Qsymia , Vivus to provide  Complet
Ltd, 13, Sector Each capsule contains 50,000 vide Dy # 699
dated 31-01-2013
following e
15, Korangi Phentermine 7.5 mg documents / descripti
Industrial Area, Topiramate 46 mg information on of
Karachi GMP
Pack size for dosage
(anti-epileptic) compliant
10s  Rs. 4300/- completion form.
Priority # 2143 Manufacture section vide
20s  Rs. 8600/- of  Formula
swapped Specification inspection
30s  Rs. 12,900/- application. tion
report dated
 Complet details
e as per
descripti innovato
on of r brand.
dosage  Stability
form. data as
 Formula per
tion guidelin
details es of
as per 251st RB
innovato meeting.
r brand.
 Stability
data as
per
guidelin
es of
251st RB
meeting.
285. M/s Hilton Capsule toploss 11.25/69 Form 5-D with FDA approved Firm needs Deferred for
dated 31-01-2013
following e
15, Korangi Phentermine 11.25 mg documents / descripti
Karachi GMP
report dated
 Complet details
e as per

descripti innovato
on of r brand.
form. data as
 Formula per
tion guidelin
details es of
st
as per 251 RB
innovato meeting.
r brand.
 Stability
data as
per
guidelin
es of
st
251 RB
meeting.
286. M/s Hilton Capsule toploss 15/92 Form 5-D with FDA approved Firm needs Deferred for
dated 31-01-2013
following e
15, Korangi Phentermine 15 mg documents / descripti
Karachi GMP
report dated
 Complet details
e as per
descripti innovato
on of r brand.
form. data as
 Formula per
tion guidelin
details es of
as per 251st RB
innovato meeting.
r brand.
 Stability
data as
per
guidelin
es of
st
251 RB
meeting.

287. M/s Hilton Ariza Injection IM Form 5-D with FDA approved Proof of Deferred for
Pharma (Pvt.) prescribed fee of Rs Abilify – segregated provision of
Ltd, 13, Sector Each 1.3ml vial contains 50,000 vide Dy # Otsuka
1302 dated 01-07-
manufacturi stability
15, Korangi Aripiprazole 9.75mg ng facility data as per
2013
Industrial Area, for guidelines
Karachi (psychotropic drug)
psychotropi provided in
Manufacture GMP
Pack size
compliant c injection 251st RB
5s  Rs. 2254/- not meeting.
section vide
10s  Rs. 4508/- provided.
inspection
30s  Rs. 13,524/-
report dated
288. M/s Hilton Ariza oral solution Form 5-D with FDA approved Proof of Deferred for
Pharma (Pvt.) prescribed fee of Rs Abilify – segregated provision of
Ltd, 13, Sector Each ml contains 50,000 vide Dy # Otsuka
1299 dated 01-07-
manufacturi stability
15, Korangi Aripiprazole 1mg ng facility data as per
2013
Industrial Area, for guidelines
Karachi (anti-psychotic)
psychotropi provided in
Manufacture GMP
Pack size
compliant c oral 251st RB
60ml  Rs. 5880/- solution not meeting.
section vide
120ml  Rs. provided.
11170/- inspection
240ml  Rs. report dated
20000/-
289. M/s Hilton Tablet Hilpru 600 mg Form 5 with Tablet Unidrox Me too Deferred for
Pharma (Pvt.) prescribed fee of Rs - Aziende status needs confirmatio
Ltd, 13, Sector Each film coated tablet 50,000 vide Dy # 104 Chimiche
dated 23-01-2013
confirmatio n of
15, Korangi contains Riunite n. approval
Industrial Area, Prulifloxacin 600mg Angelini status in
Karachi Francesco -
Pack size & price Pakistan.
(Antibiotics) A.C.R.A.F.
as per PRC
Priority # 2346 Manufacture S.p.A. Viale
Specification Amelia 70 -
00181 Rome,
Italy
Pruking
600mg,
Wilshire
GMP
compliant
section vide
inspection
report dated

290. M/s Medisearch Gerd Cure Tablet 31-08-2012 Dy # Product Deferred as
Pharmacal 8556 under product is
(Pvt.) Ltd, 5km, Each tablet contains 8000/- Form 5 Ganaton –
12000/05 -11-2013
review. under
Raiwind Manga Itopride HCl 50mg Abbott review and
Road, Lahore latest
(prokinetic / antiemetic) GMP
Pack size inspection
Priority # 669 Manufacture compliant
3 x 10  Rs. 425/- report of the
Specification section vide
inspection firm
report dated conducted
within one
year and
decision of
CLB on
recommend
ation of
PQCB,
Punjab
291. M/s Medisearch Capsule Diclofast 50mg 31-08-2012 Dy # Complete Deferred for
Pharmacal 8554 description  Complet
(Pvt.) Ltd, 5km, Each capsule contains 8000/- Form 5 Phlogin -
12000/31 -07-2013
of dosage e
Raiwind Manga Diclofenac Sodium 50 brookes form not descripti
Road, Lahore mg provided. on of
GMP
Priority # 988 (NSAID)
Pack size
compliant dosage
2 x 10  Rs. 180/- form.
Manufacture section vide
Specification inspection  Proof of
report dated approval
status of
dosage
form in
referenc
e
countire
s.
 Latest
inspectio
n report
of the
firm
conducte
d within
one year
and
decision
of CLB
on
recomm

endation
of
PQCB,
Punjab
292. M/s Medisearch Tablet Nexpro 550mg 31-08-2012 Dy # Complete Deferred for
Pharmacal 8554 description  Complet
(Pvt.) Ltd, 5km, Each tablet contains 8000/- Form 5 Anex –
12000/31 -07-2013
of dosage e
Raiwind Manga Naproxen sodium 550mg Pharmevo form not descripti
Road, Lahore eq to Naproxen 500mg provided. on of
GMP
Pack size
compliant dosage
3 x 10  Rs. 240/- form.
USP Specification section vide
inspection  Proof of
report dated approval
status of
dosage
form in
referenc
e
countire
s.
 Latest
inspectio
n report
of the
firm
conducte
d within
one year
and
decision
of CLB
on
recomm
endation
of
PQCB,
Punjab

293. M/s Pharmatec Tablet Morease SR 29-8-2012 Diclectin –  The Defererd for
Pakistan (Pvt.) 8000/- Form 5 Canada proposed  The
Ltd, D-86/A, Each film coated delayed 12000/16-01-2014
(Photocopy) formulati proposed
S.I.T.E, released tablet contains Envepe- RG on is not formulati
Karachi. Doxylamine Succinate Pharmaceutica
as per on
10mg
Priority # 1204 Vitamin B6 10mg Pack size of 30’s as innovator doesn’t
Folic Acid 2.5mg per SRO brand and match
me too in with the
(Antihistamine / ant Pakistan. already
allergy / anti nauseant )  Original registered
Manufacture challan brands
Specification receipt because
required. proposed
formulati
on
contains
folic acid
which is
not in
formulati
on of
already
registered
brands.
 Original
challan
receipt
required.
 Approval
status by
reference
regulator
authoritie
s.
 Fee
challan

294. M/s Pharmatec Tablet Lanthanate 500mg 29-8-2012 USFDA  Original Deferred for
Pakistan (Pvt.) 8000/- Form 5 approved challan  Original
Ltd, D-86/A, Each chewable tablet 12000/16-01-2014 Fosrenol –
(Photocopy) receipt challan
S.I.T.E, contains DSM required. receipt.
Karachi. Lanthanum (as carbonate Pharmaceutical
hydrate) 500mg s –Greenville  Complete  Complete
Priority # 1956 Pack size of 30’s as Blvd descriptio descriptio
(Phosphate Binder ) per SRO US Patent n of n of
Manufacture 5,968,976 dosage dosage
Specification form form.
required.  Commit
 Commit ment as
ment per
required decision
as per of 251st
decision RB
st
of 251 meeting.
RB  Latest
meeting. inspectio
 Latest n report.
inspectio  Proof of
n report approval
required. status of
 Proof of same
approval formulati
status of on /
same dosage
dosage form in
form in Pakistan.
Pakistan.  Fee
challan
295. M/s Genix Tablet Metvil 30-11-2010 MHRA Approved.
Pharma (Pvt.) Dy No.2076 Form 5 approved Photocopy
Ltd, 44,45-B, Each film coated tablet Rs.8000/- Eucreas –
Rs.12,000/-
fee
Korangi Creek contains Novartis challanswill
25-9-2013
Road, Karachi. Metformin HCl 1000mg be verified
Vildagliptin 50mg (Photocopy) Galvusmet-
by Budget
Priority # 643 Novartis
(Anti-diabetic) & Accounts
Pack size of 10’s & Division
Manufacture GMP
30’s as per SRO and
Specification compliant
section Chairman
Registration
Board will
permit
issuance of
registration
letter

296. M/s Obsons Capsule Flucob 150mg 22-6-2011 MHRA Approved.
Pharmaceuticals 8000/- Form 5 approved Photocopy
, 209-S, Each capsule contains 12000/19-12-2013 Azocan-P , fee
Industrial Fluconazole 150mg (Photocopy) FDC challanswill
Estate. be verified
Kotlakhpat, (Anti-diabetic) Fluderm-
Pack size & price by Budget
Lahore Manufacture NabiQasim
Specification as per SRO & Accounts
Priority # 1170 GMP Division
compliant and
section vide Chairman
inspection Registration
report dated Board will
07-07-2015. permit
issuance of
registration
letter
297. M/s Obsons Tablet OBMOX 400 mg Dy # 2705 MHRA Approved.
Pharmaceuticals 22-6-2011 approved Photocopy
, 209-S, Each film coated tablet Rs. 8000/- Avelox fee
Industrial contains Form 5 challanswill
Estate. Moxifloxacin (as HCl) Dy # 1281 Moxiget - Getz be verified
Kotlakhpat, 400mg 19-12-2013
by Budget
Lahore Rs. 12000/- GMP
(Antibiotics) (Photocopy) compliant & Accounts
Priority # 1171 Manufacture section vide Division
Specification inspection and
Pack size report dated Chairman
1 x 5s  Rs. 07-07-2015. Registration
692.95/- Board will
permit
issuance of
registration
letter
298. M/s Obsons Tablet AZICOB 250mg Dy # 2705 MHRA Approved.
Pharmaceuticals 22-6-2011 approved brand Photocopy
, 209-S, Each film coated tablet Rs. 8000/- of actavis, UK fee
Industrial contains Form 5 challanswill
Estate. Azithromycin (as Dy # 1281 Azopik – Wise be verified
Kotlakhpat, dihydrate) 19-12-2013
by Budget
Lahore 250mg Rs. 12000/- GMP
(Photocopy) compliant & Accounts
Priority # 1181 (Antibiotics) section vide Division
Manufacture inspection and
Specification Pack size report dated Chairman
6s  as per SRO 07-07-2015. Registration
Board will
permit
issuance of

registration
letter
299. M/s Irza Zeesulf Suspension 18/10/2012 WHO  Product Deferred as

Pharma (Pvt.) Fee Rs. 20,000/- recommended product is
is under
Ltd, 10.2km, Each 5ml of suspension Form 5 formulation review under
Lahore contains (Photocopy)
and review and
Sheikhupura Zinc Sulphate USP 20mg GMP sent for
waiting
Road, Lahore compliant
Pack size & price for comments
(Antidiarrheal ) section vide
Priority # 1917 USP Specification as per SRO inspection commen of WHO.
report dated ts of
21-03-2016 WHO.
300. M/s Irza Tablet Vilvus 50mg 18/10/2012 MHRA Approved.

Pharma (Pvt.) Dy # 211 dated 17- approved Photocopy
Ltd, 10.2km, Each tablet contains 10-2012 Galvus-
Fee Rs. 20,000/-
fee
Lahore Vildagliptin 50mg Novartis challanswill
Form 5
Sheikhupura be verified
(Anti-diabetic) (Photocopy) Galvus –
Road, Lahore
by Budget
Manufacture Novartis
Priority # 1914 Specification & Accounts
GMP
as per SRO and
compliant
21-03-2016 permit
issuance of
registration
letter
301. M/s Irza Injection I-Mide 18/10/2012 Metoclopramid Approved.
Pharma (Pvt.) Dy # 211 dated 17- e Injection – Photocopy
Ltd, 10.2km, Each 2ml contains 10-2012 Sandoz Canada
Fee Rs. 20,000/-
fee
Lahore Metoclopramide HCl challanswill
Form 5
Sheikhupura 10mg (5mg/ml) Maxolon-GSK be verified
(Photocopy)
Road, Lahore
by Budget
(Anti-dopaminergic) GMP
Priority # 1014 Manufacture compliant & Accounts
Specification section vide
as per SRO and
inspection
Board will
permit
issuance of
registration
letter

302. M/s Irza Tablet Gabatin 100mg 18/10/2012 Gabapen – Proof of Deferred for
Pharma (Pvt.) Fee Rs. 20,000/- Batala approval confirmatio
Ltd, 10.2km, Each tablet contains Form 5
status of n of
Lahore Gabapentin USP 100mg (Photocopy) GMP same approval
Sheikhupura compliant dosage form status by
Road, Lahore (Anti-epileptic) section vide
Manufacture inspection
Priority # 1916 Specification as per SRO report dated countries regulatory
21-03-2016 not authorities
provided. and fee
challan
303. M/s Irza Tablet Gabatin 300mg 18/10/2012 Gabapen – Proof of Deferred for
Pharma (Pvt.) Fee Rs. 20,000/- Batala approval confirmatio
Ltd, 10.2km, Each tablet contains Form 5
status of n of
Lahore Gabapentin USP 300mg (Photocopy) GMP same approval
Sheikhupura compliant dosage form status by
Road, Lahore (Anti-epileptic) section vide
Manufacture inspection
Priority # 1915 Specification as per SRO report dated countries regulatory
21-03-2016 not authorities
provided. and fee
challan
304. M/s Irza Neotral Sachet 02-07-2012 Approved in Firm Rejected as

Pharma (Pvt.) Rs. 8,000/- 247 th
RB doesn’t firm doesn’t
Ltd, 10.2km, Each sachet contains Form 5
17-05-2013 meeting being possess possess
Lahore Sodium Chloride 3.5gm Sachet Sachet
Rs. 12000/- high osmolar
Sheikhupura Potassium Chloride (General) (General)
1.5gm (Photocopy) formulation
Road, Lahore
Section Section
Sodium Citrate 2.9gm
Priority # 1785 Dextrose Anhydrous Peditral -Searle
Pack size & price
20gm
as per SRO GMP
(Electrolyte) compliant
Manufacture section vide
Specification inspection
report dated
21-03-2016

305. M/s Lahore Tablet ARTEMEF DS 05-09-2012 WHO Latest Approved
Chemical & Rs. 8,000/- recommended inspection with change
Pharmaceutical Each tablet contains Form 5
formulation report of brand
Works (Pvt.) Artemether 40mg (Photocopy)
Dy#1134 conducted name. firm
Ltd, 137- Lumefantrine 240mg within one has
16-12-2013 Artem - Hilton
Ferozpur Road,
Rs. 12000/- year. provided
Lahore (Antimalarial)
Manufacture requisite
Priority # 1867 Specification Commitmen documents.
Pack size t required as Photocopy
8s  Rs. 280/-
per decision fee
of 251st RB challanswill
meeting. be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
306. M/s Lahore Tablet ARTEMEF DS 05-09-2012 WHO Latest Approved
Chemical & Rs. 8,000/- recommended inspection with change
Pharmaceutical Each tablet contains Form 5
formulation report of brand
Works (Pvt.) Artemether 80mg (Photocopy)
Dy#1131 conducted name. firm
Ltd, 137- Lumefantrine 480mg within one has
16-12-2013 Artem - Hilton
Ferozpur Road,
Rs. 12000/- year. provided
Lahore (Antimalarial)
Manufacture requisite
Priority # 1868 Specification Commitmen documents.
Pack size t required as Photocopy
6s  Rs. 312/-
per decision fee
of 251st RB challanswill
meeting. be verified
by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter

307. M/s Mass Tablet VIMC-D Dy# 10276 Deferred for
Pharma (Pvt) 10-12-2012 Onsate – AGP verification
Ltd, 17-km, Each film coated tablet Rs. 20,000/-
Form 5
of atomic
Ferozepur contains:- absorption
Road, Lahore Ossein Mineral complex (Photocopy)
spectrophot
83mg eq. to residual
ometer by
Priority # 2038 mineral salts 24.8mg,
Pack size area FID
collagen 224mg, other
Per tablet  Rs. required for
protenins 88.4mg, trace
10/- analytical
elements fl,mg, Zn, Fe,
Ni, Cu) corresponding to testing of
approx 440mg the product
hydroxyapatite. and fee
challan
308. M/s Sharex Pyodex Solution 10% Dy# 3539 MHRA Latest Deferred for
Laboratories 16-03-2011 approved inspection Latest
(Pvt.) Ltd, KLP, Each 100ml contains:- Rs. 8,000/- Betadine
Form 5
report inspection
Road, Iodinated povidone 10gm required report
Dy #1084
Sadiqabad eq to iodine 1gm Poviderm - conducted
29-05-2014
Bexter
within one
Priority # 285 Antiseptic
USP specification year and
Pack size section
Per tablet  Rs.
10/-
309. M/s Sharex Cynoplex Injection Dy# 3271 Murfy plex – Latest Deferred for
Laboratories 08-03-2011 Murfy inspection  Latest
(Pvt.) Ltd, KLP, Each 2ml ampoule Rs. 8,000/-
Form 5
report inspectio
Road, contains:- required n report
Dy #1087
Sadiqabad Vitamin B1 BP 10mg
29-05-2014 conducte
Vitamin B2 BP 2mg
Priority # 285 Vitamin B6 BP 5mg d within
Nicotinamide BP 75mg one
Pack size year.
Dexpanthanol BP 5mg 25s  Rs. 90/-
 Confirm
Vitamin ation of
Manufacture specification approval
status by
referenc
e
regulator
authoriti
es and
Pakistan

310. M/s Basel Capsule Befol Vit Dy# 843 Fefol-vit, GSK Latest Deferred for
Pharmaceuticals 21-11-2013 inspection  Latest
, 227-Phase II, Each capsule contains:- Rs. 20,000/-
Form 5
report inspectio
Multan Dried ferrous Sulphate required n report
Industrial 150mg Commitmen required
Estate, Multan Folic acid 0.5mg
Thiamine mononitrate
Pack size t required  Commit
10s  Rs. 141/- Complete ment as
Priority # 285 2mg
Riboflavin 2mg manufacturi per
Pyridoxine HCl 1mg ng method decision
Nicotinamide 10mg required of 251st
Ascorbic acid 50mg RB
meeting.
Vitamins  Complet
Manufacture specification
e
manufac
turing
method.
 Vitamin
policy
311. M/s Zafa ZipPain 25mg Capsule 28-11-2013 FDA approved Stability Deferred for
Pharmaceutical Dy.No.2039 Zipsor - US data as per provision of
Laboratories Each softgel capsule Form 5-D Patents:
Rs.50,000/-
guidelines Stability
(Pvt.) Ltd, L- contains 6,365,180; provided in data as per
1/B, Block 22, Diclofenac Potassium (Photocopy) 7,662,858; 251st RB guidelines
Federal “B” 25mg 7,884,095;
meeting. provided in
Industrial Area, 7,939,518;
Karachi (NSAID)
Pack size & price
8,110,606; 251st RB
as per SRO meeting and
Manufacture 6,287,594;
Priority # 2742 Specification 8,623,920 fee challan
Distributed by:
Depomed, Inc.
Newark, CA
94560, USA
Issued: 5/2016
312. M/s Zafa Tablet Durata 30 mg 28-11-2013 MHRA The product Deferred for
Pharmaceutical Form 5 approved in proposed provision of
Laboratories Each film coated tablet Rs.20,000/- Priligy strength is application
(Pvt.) Ltd, L- contains (Photocopy)
not yet on
1/B, Block 22, Dapoxetine HCl eq to registered in prescribed
Federal “B” Dapoxetine 30mg
Pack size & price Pakistan. Form 5-D
Industrial Area,
Karachi (SSRIs) as per SRO because
Manufacture product in
Priority # 1989 Specification proposed

strength is
not yet
registered in
Pakistan
and fee
challan
313. M/s Highnoon Tablet Cidine XR 22-11-2012 Proof of Deferred for

Laboratories Fee Rs. 20,000/- approval confirmatio
Ltd, 17.5km, Each extended released Form 5
status of n of
Multan Road, tablet contains (Photocopy)
same approval
Lahore Cinitapride as acid formulation status of
tartrate 3mg
Pack size & price in same same
Priority # 2381
(Prokinetic drugs) as per SRO strength in formulation
Manufcature reference by reference
Specification countries & regulatory
Pakistan. authorities
and
Pakistan
and fee
challan
314. M/s Highnoon Tablet Cidine XR 3-10-2011 Proof of Deferred for
Laboratories Form 5-D approval confirmatio
Ltd, 17.5km, Each tablet contains 15000/-
35000/30-07-2013
status of n of
Multan Road, Dexrabeprazole sodium same approval
Lahore 5mg (Photocopy)
formulation status of
in same same
Priority # 2747 (Proton Pump Inhibitor)
Pack size strength in formulation
Manufcature
10s  Rs. 150/- reference by reference
Specification
14s  Rs. 210/- countries & regulatory
28s  Rs. 420/- Pakistan. authorities
and
Pakistan
and fee
challan
315. M/s Highnoon Capsule Tres-Orix forte 18-10-2012 Proof of Deferred for
Laboratories Form 5 approval confirmatio
Ltd, 17.5km, Each capsule contains 20000/-
status of n of
Multan Road, Carnitine Hydrochloride (Photocopy)
same approval
Lahore 150mg Lysine
Hydrochloride 150mg formulation status of
Coenzyme B12 1mg Pack size in same same
Priority # 2380
swapped
Cyproheptadine orotate 10s  Rs. 100/- strength in formulation
1.5mg 14s  Rs. 200/- reference by reference
28s  Rs. 300/- countries & regulatory
(Nutritional Supplement)
Pakistan. authorities
and

Pakistan nd
fee challan.
316. M/s Highnoon Tablet Spasnol 80/80 18-10-2013 Spasfon – Deferred as

Laboratories Form 5 France product /
Ltd, 17.5km, Each tablet contains 20000/-
formulation
Multan Road, Phlorglucinol 80mg (Photocopy) Spasfon - is under
Lahore Trimethylphlorglucinol Himont review.
80mg
Pack size as per The Board
Priority # 2748
swapped (Antispasmodic) SRO advised to
Manufacture specification issue
reminder
for to
experts for
their
opinion
317. M/s Seatle Tablet Exlem 3mg 18-10-2013 TGA approved Proof of Rejected as
(Private) Form 5 Lexotan- manufacturi firm doesn’t
Limited, 45-km, Each tablet contains 20000/- Roche ng facility possess
Multan Road, Bromazepam 3mg (Photocopy)
of tablet segregated
Lahore Lexotanil
psychotropi manufacturi
(Benzodiazepines) Roche
c ng facility
Priority # 2414 Manufacture specification Pack size as per
SRO of tablet
psychotropi
c as per
requirement
of Central
Licensing
Board.
318. M/s Merck Tablet Osteolock 05-11-2012 Gevolox – Deferred for
(Private) Dy # 1728 Form 5 Hilton confirmatio
Limited, 7, Jail Each film coated tablet Rs.20,000/-
n of
Road, Quetta contains (Photocopy) GMP approval
Glucosamine Sulphate compliant status of
Priority # 1969 2KCl USP eq. to section vide
Pack size same
Glucosamine Sulphate inspection
500mg 20s  Rs. 320/- report dated formulation
Chondroitin Sulphate 13-14 May by reference
USP 400mg 2016 regulatory
authorities
(Osteoarthritis) and fee
Manufacture challan.
specification

319. M/s Merck Lumairia Dry Suspension 16-11-2011 WHO Approved.
(Private) Dy.No.361 Form 5 recommended Photocopy
Limited, 7, Jail Each 5ml of reconstituted Rs.8000/- formulation
Rs.12,000/-
fee
Road, Quetta suspension contains challanswill
05-09-2013
Artemether 15mg Artem – Hilton be verified
Lumefantrine 90mg (Photocopy)
Priority # 1429
by Budget
GMP
(Antimalarial) compliant & Accounts
Pack size Division
Manufacture section
30ml  Rs. 90/- and
specification
Chairman
Registration
Board will
permit
issuance of
registration
letter
320. M/s Merck Lumairia Tablet 80/480 16-11-2011 WHO Approved.
Limited, 7, Jail Each Tablet contains Rs.8000/- formulation
Rs.12,000/-
fee
Road, Quetta Artemether 80mg challanswill
05-09-2013
Lumefantrine 480mg Artem – Hilton be verified
(Photocopy)
Priority # 1424
by Budget
(Antimalarial) GMP
Manufacture compliant & Accounts
Pack size Division
specification section
30ml  Rs. 90/- and
Chairman
Registration
Board will
permit
issuance of
registration
letter
Rs.12,000/-
fee
05-09-2013
(Photocopy)
Priority # 1431
by Budget
(Antimalarial) GMP
Pack size Division
10s  Rs. 264/- and
Chairman
Registration
Board will
permit
issuance of

registration
letter

Rs.12,000/-
fee
05-09-2013
(Photocopy)
Priority # 1428
by Budget
(Antimalarial) GMP
Pack size Division
16s  Rs. 320/- and
Chairman
Registration
Board will
permit
issuance of
registration
letter
323. M/s Merck Mercip Powder for 16-11-2011 Product Deferred as
(Private) suspension 250mg/5ml Dy.No.361 Form 5 under product is
Limited, 7, Jail Rs.8000/- GMP
Rs.12,000/-
review. under
Road, Quetta Each 5ml of reconstituted compliant review.
05-09-2013
suspension contains section
(Photocopy) The
Priority # 2049 Ciprofloxacin HCl.2H2O
innovator The
USP eq to Ciprofloxacin
250mg brand is in innovator
Pack size base form brand is in
60ml  Rs. 160/- while it is inbase form
(Antibiotics)
USP specification salt form. while it is in
salt form.
324. M/s Merck Mercip Powder for 13-12-2012 The Rejected as
(Private) suspension 125mg/5ml Dy.No.361 Form 5 proposed the
Limited, 7, Jail Rs. 20,000/- GMP dosage form proposed
Road, Quetta Each 5ml of reconstituted (Photocopy) compliant doesn’t dosage form
suspension contains section exist in this doesn’t
Priority # 2048 Ciprofloxacin HCl.2H2O
Pack size strength in exist in
USP eq to Ciprofloxacin
250mg 60ml  Rs. 90/- reference proposed
countries. strength in
(Antibiotics) reference
USP specification countries.

325. M/s Star Irosoft Injection 17-07-2013 TGA approved Approved
Laboratories Form 5 Venofer – with change
(Pvt.) Ltd, 23- Each 5ml contains Rs. 20,000/- Aspen Pharma of brand
km, Multan Ferric sucrose complex (Photocopy) Australia name.
Road, Lahore eq to elemental iron Photocopy
100mg Venofer-RG
Pack size of fee
Priority # 2400
swapped (Iron preparation) ampoule GMP challanswill
USP specification 5ml x 5  Rs. compliant be verified
1250/- section by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
326. M/s Star Irosoft Syrup 17-07-2013 TGA approved Approved
Laboratories Form 5 Maltofer – with change
(Pvt.) Ltd, 23- Each 5ml contains Rs. 20,000/- Aspen Pharma of brand
km, Multan Iron (III) hydroxide (Photocopy) Australia name.
Road, Lahore polymaltose complex eq. Photocopy
to elemental iron 50mg Ferosoft-Hilton
Pack size of fee
Priority # 2636
swapped (Iron preparation) ampoule GMP challanswill
USP specification 5ml x 5  Rs. compliant be verified
1250/- section by Budget
& Accounts
Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter

327. M/s Pharmix Tablet Pepzym 30-09-10 Plasil with Deferred for
Laboratories Rs.8000/- Form 5 enzyme – confirmatio
(Private) Each coated tablet 30-7-2013 Pacific
Rs. 12000/-
n of
Limited, 21-km, contains approval
Ferozepur Pancreatin USP 210 FIP (Photocopy) GMP status by
Road, Lahore P.U compliant
reference
Metoclopramide section
Pack size of regulatory
Priority # 402 (HCL.2H2O) 6mg
30s  Rs. 300/- authorities
Bromelain 35000 P.U.
Polysiloxane 50mg and fee
Sodium Dehydrocholate challan
20mg
(Digestive Enzyme)
328. M/s Pharmix Tablet Vital 08-09-2010 Occulovit – Deferred for

Laboratories Rs.8000/- Form 5 Ethical confirmatio
(Private) Each film coated tablet 30-7-2013 Laboratories
Rs. 12000/-
n of
Limited, 21-km, contains approval
Ferozepur Vitamin A (Acetate) USP (Photocopy) GMP status by
Road, Lahore 5000 I.U compliant
reference
Vitamin C (Ascorbic section
Pack size of regulatory
Priority # 400 Acid) BP 500mg
30s  Rs. 510/- authorities,
Vitamin E USP 200 I.U
Vitamin D vitamin
(Cholecalciferol D3) USP policy and
100 I.U fee challan
Folic Acid BP 200 mcg
Vitamin B1 (Thiamine
mononitrate) USP 15mg
Vitamin B2 (Riboflavin)
USP 15mg
Zinc BP 40mg
Copper BP 2mg
Manganses BP 1.5mg
Selenium BP 40.5mcg
(Vitamins/ minerals)
329. M/s Pharmix Polyrol Syrup 21-12-2010 TGA approved Approved.

Laboratories Rs.8000/- Form 5 Maltofer- Photocopy
(Private) Each 5ml contains: 30-7-2013 Aspen Pharma,
Rs. 12000/-
fee
Limited, 21-km, Iron (III) Hydroxide Australia challanswill
Ferozepur Polymaltose Complex (Photocopy)
be verified
Road, Lahore Eq. to elemental Iron Ferosoft -
by Budget
………50mg Hilton
Pack size of & Accounts
Priority # 688
30ml & 60ml as per Division
Iron preparation
SRO and
Manufacture GMP

specification compliant Chairman
section Registration
Board will
permit
issuance of
registration
letter
330. M/s Pharmix Tablet Vitamax 30-9-2010 Once a Day – Deferred for
Laboratories Rs.8000/- Form 5 CCL confirmatio
(Private) Each tablet contains 30-7-2013 n of
Limited, 21-km, Vitamin A (Acetate) USP Rs. 12000/- GMP approval
Ferozepur 10mg (Photocopy) compliant status by
Road, Lahore Vitamin C (Ascorbic section
reference
acid) USP 60mg
Priority # 401 Vitamin E USP 30mg Pack size of regulatory
Vitamin D 30s  Rs. 390/- authorities,
(Cholecalciferol D3) USP vitamin
10 mcg policy and
Folic Acid USP 0.400mg fee challan
Vitamin B1 (Thiamine
mononitrate) USP
1.50mg
Vitamin B2 (Riboflavin)
USP 1.70mg
Vitamin B6 (Pyridoxine)
USP 2 mg
Vitamin B12
(Cyanocobalamin) USP 6
mcg
Niacin USP 20mg
Pantothenic acid USP
10mg
D-Biotin USP 30 mcg
Calcium USP 130mg
Phosphorus USP 100mg
Iodine USP 150 mcg
Iron USP 18 mg
Magnesium USP 100mg
Copper USP 2mg
Zinc USP 15mg
Potassium USP 37.50mg
Maganese USP 2.50mg
Chromium USP 10 mcg
Molybdenum USP 10
mcg
Selenium USP 10 mcg
Chloride USP 34 mg

(Digestive Enzyme)
331. M/s Renacon Renacit Hemodialysis 19-11-2012 Renasol –  The Deferred for
Pharma (Pvt.) Concentrate Dry (RCTD) Rs.20000/- Form 5 Minntech re-
internatio
Ltd, 18-km, (Photocopy) evaluation
nal
Ferozpur Road, After mixing and dilution License availabilit and
Opp Nishtar of Part A & Part B by the renewed on 21- comparison
Pack size of y
Colony, Lahore Haemodialysis machine, 09-2015.
30s  Rs. 300/- provided of
the resultant concentrate:-
Priority # 1991 Sodium 140 mmol/L GMP is formulation
Potassium 2.0 mmol/L compliant different approved by
Calcium 1.5 mmol/L section in regulatory
Magnesium 0.75 mmol/L compositi authorities
Chloride 109.25 mmol/L on from of reference
Citrate 0.8 mmol/L proposed countires
Bicarbonate 35.0 mmol/L formulati and fee
Glucose 5.5 mmol/L on. challan.
Part A:-
Sodium 105.0 mmol/L
Potassium 2.0 mmol/L
Calcium 1.5 mmol/L
Magnesium 0.75 mmol/L
Chloride 109.25 mmol/L
Citrate 0.8 mmol/L
Glucose 5.5 mmol/L
Part B:-
Sodium 35 mmol/L
Bicarbonate 35 mmol/L
(Concentrate for
Bicarbonate
Hemodialysis)
Manufacture
specification
332. M/s Pharmacare Pharxime DS Suspension 27-12-2011 FDA Approved Approved.

Labs (Pvt.) Ltd, Rs.8000/- Form 5 brand suprax Photocopy
129/1 Industrial Each 5ml of reconstituted 30-7-2013
Rs. 12000/-
fee
Estate, Kot suspension contains:- Caricef-sami challanswill
Lakhpat, Cefixime trihydrate eq to (Photocopy)
be verified
Lahore cefixime 200mg GMP
by Budget
compliant
Priority # 1463 (Cephalosporin) section vide
as per leader brand Division
USP specification inspection
report dated and
29-07-2015 Chairman
Registration
Board will

permit
issuance of
registration
letter
333. M/s Pharmacare Tablet Malout 27-12-2011 WHO Approved.

Labs (Pvt.) Ltd, Rs.8000/- Form 5 recommended Photocopy
129/1 Industrial Each tablet contains:- 30-7-2013 formulation
Rs. 12000/-
fee
Estate, Kot Artemether 80mg challanswill
Lakhpat, Lumefantrine 480mg (Photocopy) Artem - Hilton be verified
Lahore
by Budget
(Antimalarial)
Priority # 1461 Manufacture GMP
specification compliant
section vide and
inspection Chairman
permit
issuance of
registration
letter
334. M/s Friends Injection Frendic 75mg 28-5-2011 FDA approved Approved.
Pharma (Pvt.) Rs.8000/- Form 5 Dycloject – Photocopy
Ltd, 31-km, Each 3ml ampoule 14-5-2013 Javelin pharms
Rs.12000/-
fee
Ferozpur Road, contains:- challanswill
Lahore Diclofenac sodium 75mg (Photocopy) Deborn-L be verified
(Wellborne)
by Budget
GMP
compliant and
section 16-02- Chairman
2016 Registration
Board will
permit
issuance of
registration
letter
335. M/s Friends Fledonil Injection 28-5-2011 FDA approved Approved.
Pharma (Pvt.) Rs.8000/- Cyclokapron – Photocopy
Ltd, 31-km, Each ampoule of 5ml 14-5-2013 Pfizer
Rs.12000/-
fee
Ferozpur Road, contains:- challanswill
Lahore Tranexamic acid 500mg (Photocopy) Brino -Sami be verified
by Budget
Priority # 1093 Anti fibrinolytic
Manufacture specification GMP
compliant
section and

Chairman
Registration
Board will
permit
issuance of
registration
letter
336. M/s Friends Xylodent Injection 31-12-2012 FDA approved Approved
Pharma (Pvt.) Form 5 - Rs. 20000/- product
Ltd, 31-km, Each ml contains:- Dy # 10383 dated
Ferozpur Road, Lidocaine HCl 20mg 31-12-2012 A product of
Lahore Epinephrine (as tartrate) Harmaann,
10 ug lahore
Priority # 2091 Pack size
(Anesthetic agent) 2ml ampoule as per
USP specification leader brand GMP
compliant
section
337. M/s Friends Phenate Injection 28-5-2011 Avil-Sanofi, Approved.

Pharma (Pvt.) Rs.8000/- Form 5 Germany Photocopy
Ltd, 31-km, Each 2ml contains:- 14-5-2013
Rs.12000/-
fee
Ferozpur Road, Phenireamine maleate AVil-sanofi challanswill
Lahore 45.5mg (Photocopy)
be verified
Pack size by Budget
Priority # 1096 (Antihistamine) GMP
JP specification 2ml ampoule as per compliant & Accounts
leader brand section Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
338. M/s Friends Norobion Injection 28-5-2011 Neurobion - Approved
Pharma (Pvt.) Rs.8000/- Form 5 France with change
Ltd, 31-km, Each 3 ml ampoule 14-5-2013
Rs.12000/-
of brand
Ferozpur Road, contains:- Neurobion - name.
Lahore Vitamin B1 100mg Merck
Vitamin B6 100mg Pack size & price
Priority # 1088 Vitamin B12 1000mcg as per leader brand
GMP
(Vitamin) compliant
Manufacture specification section

339. M/s Pakistan Tablet Vastec 20mg 23-04-2011 MHRA Approved.
Pharmaceutical Dy.No.986 Form 5 approved Photocopy
Products (Pvt.) Each film coated tablet Rs.8000/- crestor -
(Photocopy)
fee
Ltd, D-122, contains:- Astrazeneca challanswill
Rs.12,000/-
S.I.T.E, Karachi Rosuvastatin (As be verified
31-07-2013
calcium) 20mg Amro-
by Budget
Priority # 1002 Amarant
(Lipid regulating drug) & Accounts
Manufacture specification as per leader brand
GMP and
compliant Chairman
section vide Registration
inspection Board will
report dated permit
31-12-2015 issuance of
registration
letter
340. M/s Pakistan Tablet Candia 32mg 23-04-2011 MHRA Approved.
Products (Pvt.) Each tablet contains:- Rs.8000/- Amias –
(Photocopy)
fee
Ltd, D-122, Candesartan Cilexetil Takeda challanswill
Rs.12,000/-
S.I.T.E, Karachi 32mg
Carac -
by Budget
Priority # 1021 (Anti hypertensive ) Wilshire
Manufacture specification Pack size & price & Accounts
Division
as per leader brand
GMP and
compliant Chairman
report dated permit
31-12-2015 issuance of
registration
letter
341. M/s Pakistan Tablet Candia 4mg 30-04-2011 MHRA Approved.
Products (Pvt.) Each tablet contains:- Rs.8000/- Amias –
(Photocopy)
fee
Ltd, D-122, Candesartan Cilexetil Takeda challanswill
Rs.12,000/-
S.I.T.E, Karachi 4mg be verified
31-07-2013
Carac -
by Budget
Priority # 1018 (Anti hypertensive ) Wilshire
Manufacture specification Pack size & price & Accounts
Division
as per leader brand and
GMP
compliant Chairman
report dated permit
31-12-2015

issuance of
registration
letter
342. M/s Pakistan Tablet Zolot 75 mg 30-04-2011 MHRA Approved.

Pharmaceutical Dy.No.1061 Form 5 approved brand Photocopy
Products (Pvt.) Each film coated tablet Rs.8000/- of Accord
(Photocopy)
fee
Ltd, D-122, contains:- challanswill
Rs.12,000/-
S.I.T.E, Karachi Clopidogrel (as Hydrogen Lowplat - be verified
31-07-2013
Sulphate) 75mg Pharmevo
by Budget
Priority # 1020
(Antiplatelet) & Accounts
USP specification as per leader brand GMP
compliant and
31-12-2015 permit
issuance of
registration
letter
343. M/s Pakistan Tablet Alfa-one 30-04-2011 Alfa-D Approved.
Pharmaceutical Dy.No.1056 form 5 (Platinum) Photocopy
Products (Pvt.) Each tablet contains:- Rs.8000/-
(Photocopy)
fee
Ltd, D-122, Alfacalcidol 0.5 ug GMP challanswill
Rs.12,000/-
S.I.T.E, Karachi compliant be verified
31-07-2013
(Vitamin D analogue) section vide
by Budget
Priority # 1019 USP specification inspection
report dated & Accounts
as per leader brand 31-12-2015
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
344. M/s Pakistan Zinkid 20mg / 5ml Syrup 30-04-2011 WHO Product Deferred as
Pharmaceutical Dy.No.1056 form 5 recommended under product is
Products (Pvt.) Each 5ml contains: Rs.8000/- formulation
(Photocopy)
review as under
Ltd, D-122, Elemental Zinc as zinc waiting for review and
Rs.12,000/-
S.I.T.E, Karachi sulphate Kilin -Linear reply of sent for
31-07-2013
monohydratre..……20 GMP
WHO. views of
Priority # 1530 mg compliant
section vide WHO.
Pack size & price
(Mineral Supplement) as per leader brand inspection
USP specification report dated
31-12-2015

345. M/s Highnoon Tablet Ivahi 7.5mg 04-11-2013 MHRA Stability Deferred for
Laboratories form 5-D approved data provison of
Ltd, 17.5 km , Each film coated tablet Rs.50000/- Procoralan –
(Photocopy)
Multan Road, contains: Servier per data as per
Lahore Ivabradine HCl eq to guidelines guidelines
Ivabradine 7.5mg Pack size GMP
Priority # 2629 10s  Rs. 2500/- compliant
provided in provided in
(Anti angina ) 20s  Rs. 5000/- section vide 251st RB 251st RB
USP specification inspection meeting. meeting and
report dated fee challan.
09-03-2015
346. M/s Highnoon Tablet Ivahi 5mg 04-11-2013 Stability Deferred for
Laboratories form 5-D GMP data provision of
Ltd, 17.5 km , Each film coated tablet Rs.50000/- compliant
(Photocopy)
Multan Road, contains: section vide per data
Lahore Ivabradine HCl eq to inspection guidelines required as
Ivabradine 5mg Pack size report dated
Priority # 2628 10s  Rs. 1500/- 09-03-2015
provided in per
(Anti angina ) 20s  Rs. 3000/- 251st RB guidelines
USP specification meeting. provided in
251st RB
meeting and
fee challan.
347. M/s Life Caliz Dry suspension 20-11-2012 Form 5 MHRA Approved.
Pharmaceutical 20000/- (Photocopy) approved brand Photocopy
company, 24-III Each 5ml of reconstituted of Sandoz fee
Industrial Estate suspension contains: Pack size
challanswill
Multan Azithromycin Dihydrate 15ml  Rs. 300/- Azomax –
25 ml  Rs. 480/- be verified
eq to Azithromycin Novartis
by Budget
Priority # 1992 200mg
GMP & Accounts
(Antibiotics ) compliant Division
USP specification section and
Chairman
Registration
Board will
permit
issuance of
registration
letter
348. M/s Swiss Tablet Desotin 5mg 11-01-2011 MHRA Approved.
Pharmaceuticals Dy.No.90 Form 5 approved brand Photocopy
(Pvt.) Ltd, Each film coated tablet Rs.12,000/- of Consilient
05-02-2013
fee
A/159, S.I.T.E, contains: challanswill
(Photocopy)
Super Highway, Desloratadine 5mg Alenor – be verified
Karachi Macter
Pack size by Budget
(Antihistamine)
Manufacture specification 10s  as per PRC & Accounts
Priority # 810 GMP
compliant Division
section vide and

inspection Chairman
permit
issuance of
registration
letter
349. M/s Swiss Tablet Alfadol 1mcg 11-01-2011 Approved.

Pharmaceuticals Dy.No.87 Form 5 Adela - getz Photocopy
(Pvt.) Ltd, Each tablet contains: Rs.8000/-
Rs.12,000/-
fee
A/159, S.I.T.E, Alfacalcidol 1.0 mcg GMP challanswill
05-02-2013
Super Highway, compliant be verified
(Photocopy)
Karachi (Vitamin D Analogue) section vide
by Budget
inspection
Priority # 803 report dated
10s  as per PRC Division
31-08-2015
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
350. M/s Swiss Spasno 40mg Injection 11-01-2011 Spasfon – Product Deferred as
Pharmaceuticals Dy.No.87 Form 5 France under product is
(Pvt.) Ltd, Each 4ml contains:- Rs.8000/-
Hydrated Rs.12,000/-
review. under
A/159, S.I.T.E, Spasfon – review and
Phloroglucinol.40mg 05-02-2013
Super Highway, Himont fee challan
Trimethylphloroglucinol (Photocopy)
Karachi 0.04mg
GMP
Pack size
Priority # 1060 (Anti Spasmodic) compliant
10s  as per PRC
Manufacture Specification section vide
inspection
report dated
31-08-2015
351. M/s Swiss Laxolac 3.35gm Syrup 11-01-2011 MHRA. Source of Deferred for
Pharmaceuticals Dy.No.117 Form 5 Duphalac Lactulose Source of
(Pvt.) Ltd, Each 5ml contains:- Rs.8000/- 3.35g/5ml By
Lactulose USP 3.35gm Rs.12,000/-
required lactulose,
A/159, S.I.T.E, M/s BGP along with fee, GMP,
05-02-2013
Super Highway, fee and stability
(osmotic lexative) (Photocopy)
Karachi USP Specification Local.
documents. data, fee
Duphalac
Pack size & price challan.
Priority # 806 3.35g/5ml by
as per SRO
M/s Highnoon
GMP
compliant
section vide

inspection
report dated
31-08-2015
352. M/s Swiss Tablet Lufid 20mg 12-04-2011 MHRA.Arava- Approved.

Pharmaceuticals Dy # 883 Form 5 Sanofi Photocopy
(Pvt.) Ltd, Each film coated tablet Rs.8000/-
contains:- Rs.12,000/-
fee
A/159, S.I.T.E, Adira - challanswill
Leflunomide 20mg 05-02-2013
Super Highway, Wilshire be verified
(Photocopy)
Karachi (Anti rheumatic) by Budget
GMP
USP Specification Pack size of 30s  & Accounts
Priority # 975 compliant
as per SRO Division
section vide
inspection and
Board will
permit
issuance of
registration
letter
353. ] M/s Swiss Ironate 800mg/15ml Syrup 12-04-2011 Approved.
Pharmaceuticals Dy # 883 Form 5 EMICO-NOA Photocopy
(Pvt.) Ltd, Each 15ml contains:- Rs.8000/- HEMIS
Iron Protein Succinylate Rs.12,000/-
fee
A/159, S.I.T.E, challanswill
800mg eq to elemental iron 05-02-2013
Super Highway, GMP
40mg (Photocopy) be verified
Karachi compliant
by Budget
section vide
(Anti anemic) Pack size of 30s  & Accounts
Priority # 1030 USP Specification inspection
as per SRO Division
report dated
31-08-2015 and
Chairman
Registration
Board will
permit
issuance of
registration
letter
354. M/s Swiss Tablet CartiPLUS 31-5-2011 Me too Deferred for
Pharmaceuticals Dy.No.1435 Form 5 Cartigen plus – needs confirmatio
(Pvt.) Ltd, Each film coated tablet Rs.8000/- Getz
confirmatio n of
A/159, S.I.T.E, n approval
Glucosamine Sulphate 05-02-2013
Super Highway, GMP
750mg (Photocopy) status by
Karachi Chondroitin Sulphate compliant
reference
section vide
600mg Pack size of 30s  regulatory
Priority # 1101 inspection
as per SRO authorities
(Musculo-skeletal product) report dated
Manufacture Specification 31-08-2015 and
Pakistan
and fee

challan
355. M/s Swiss Injection Cefot 2gm 11-01-2011 Approved.
Pharmaceuticals Dy.No.89 Form 5 Cebac -Bosch Photocopy
(Pvt.) Ltd, Each vial contains:- Rs.12,000/-
Cefoperazone Sodium USP 05-02-2013
fee
A/159, S.I.T.E, GMP challanswill
eq to Cefoperazone 1gm (Photocopy)
Super Highway, compliant be verified
Salbactam sodium eq to
Karachi section vide
salbactam 1 gm Pack size of 1s  by Budget
inspection
as per SRO & Accounts
Priority # 217 (Antibiotics) report dated
Manufacture Specification 31-08-2015 Division
and
Chairman
Registration
Board will
permit
issuance of
registration
letter
356. M/s Swiss Tablet Rapral 10mg 12-04-2011 MHRA Approved.
Pharmaceuticals Dy.No.885 Form 5 approved Pariet Photocopy
(Pvt.) Ltd, Each enteric coated tablet Rs.8000/- – Eisai
fee
Rabeprazole (as sodium) 05-02-2013
Super Highway, Rabecid -
10mg (Photocopy) be verified
Karachi Highnoon
by Budget
(Proton Pump Inhibitor) Pack size of 10s  & Accounts
Priority # 968 Manufacture Specification GMP
as per SRO Division
compliant
section vide and
inspection Chairman
permit
issuance of
registration
letter
357. M/s Swiss Tablet Swiss Mether 40/240 30-7-2010 WHO Approved.
Pharmaceuticals Dy.No.1512 Form 5 recommended Photocopy
(Pvt.) Ltd, Each tablet contains:- Rs.8000/- formulation
Artemether 40mg Rs.12,000/-
fee
Lumefantrine 240mg 05-09-2013
Super Highway, Artem -Hilton
(Photocopy) be verified
Karachi (antimalarial) by Budget
Manufacture Specification GMP
Pack size of 1 x 16s & Accounts
Priority # 805 compliant
 as per SRO Division
swapped section vide
inspection and
Board will
permit

issuance of
registration
letter
358. M/s Swiss Tablet Swiss Mether 30-7-2010 WHO Approved.
Pharmaceuticals 80/480 Dy.No.1511 Form recommended Photocopy
(Pvt.) Ltd, 5 formulation fee
A/159, S.I.T.E, Each tablet contains:- Rs.8000/- challanswill
Super Highway, Artemether 80mg Rs.12,000/- Artem -Hilton be verified
Karachi Lumefantrine 480mg 05-09-2013
by Budget
(Photocopy) GMP
Priority # 809 (antimalarial) compliant & Accounts
swapped Manufacture Pack size of 1 x 6s section vide Division
Specification  as per SRO inspection and
Board will
permit
issuance of
registration
letter
359. M/s Amarant Amate 7.5mg Tablet 19-10-2012 Tablet L-  Firm Deferred for
Pharmaceuticals Dy.No.1305 Form 5- Methylfolate needs to  Remaini
(Pct.) Ltd, 158- Each film coated tablet D 7.5mg – Virtus
Rs.20,000/- submit ng fee
D, Tora Gadap contains: Pharmaceutical remainin for
(Photocopy)
Road, Super Calcium 1-5- s, USA
g fee for prescrib
Highway, methyltetrahydrofolate
Karachi eq. to 1-
Pack size of 10s &
GMP prescrib ed Form
30s  as per SRO ed Form 5-D.
methylfolate….7.5 mg compliant
Priority # 1926 section vide 5-D.  Stability
(Adjunctive use in major inspection  Firm data as
depressive and report dated needs to per
schizophrenia) 31-08-2015 submit guidelin
stability es
data as provided
per in 251st
guidelin RB
es meeting.
provided  Fee
in 251st challan
RB
meeting.
360. M/s Amarant Amate 15mg Tablet 19-10-2012 Tablet L-  Firm Deferred for
Pharmaceuticals Dy.No.1306 Form 5- Methylfolate needs to  Remaini
(Pct.) Ltd, 158- Each film coated tablet D 15mg – Virtus
Rs.20,000/- submit ng fee
D, Tora Gadap contains: Pharmaceutical remainin for
(Photocopy)
Road, Super Calcium 1-5- s, USA
g fee for prescrib
Highway, methyltetrahydrofolate
Karachi eq. to 1-
Pack size of 10s &
GMP prescrib ed Form
30s  as per SRO ed Form 5-D.
methylfolate….15 mg compliant

Priority # 1927 section vide 5-D.  Stability
(Adjunctive use in major inspection  Firm data as
depressive and report dated needs to per
schizophrenia) 31-08-2015 submit guidelin
stability es
data as provided
per in 251st
guidelin RB
es meeting.
provided  Fee
in 251st challan
RB
meeting.
361. M/s Linear Tablet Betalin 16mg 17-12-2013 MHRA Approved
Pharma, Plot # Rs. 12000/- approved brand
18, Street S-4, Each tablet contains: Dy.No.846 of Aurobindo.
National Betahistine 16mg Form 5
02-11-2010
Industrial Zone, Serc-Abbott
Rs.12,000/-
Rawat. Antihistamine
Manufacture
Priority # 485 Specification Pack size & price Inspection
as per SRO report dated
19-01-2016
362. M/s Linear Tablet Betalin 8mg 17-12-2013 MHRA Approved
18, Street S-4, Each tablet contains: Dy.No.8140 of Aurobindo.
National Betahistine 8mg Form 5
02-11-2010
Industrial Zone, Serc-Abbott
Rs.12,000/-
Rawat. Antihistamine
Manufacture GMP
Priority # 484 Specification Pack size & price compliant
as per SRO section
363. M/s Linear Tablet Linakast 10mg 17-12-2013 MHRA Approved

18, Street S-4, Each film coated tablet Dy.No.8133 of Accord
National contains: Form 5
02-11-2010
Industrial Zone, Montelukast (as sodium) Serc-Abbott
Rs.12,000/-
Rawat. 10mg
Priority # 513 Antihistamine Pack size & price

Manufacture as per SRO
Specification

364. M/s Linear Tablet Heam 500 mcg 17-12-2013 Methycobal – Approved
Pharma, Plot # Rs. 12000/- Eisai, Japan
18, Street S-4, Each sugar coated tablet Dy.No.8147
06-10-2010
Industrial Zone, Mecobalamin 500 mcg Anemovit -
Rs.12,000/-
Rawat. Pharmacare
Vitamin
Priority # 484 Manufacture Pack size & price
Specification as per SRO
365. M/s Linear Tablet Melix 15mg 17-12-2013 USFDA Approved
Pharma, Plot # Rs. 12000/- MOBIC -
18, Street S-4, Each uncoated tablet Dy.No.8136 Boehringer
Industrial Zone, Meloxicam USP 15mg 06-10-2010 ALOXI -
Rawat. Rs.12,000/- ALSON
NSAID
Priority # 515 Manufacture
Specification Pack size & price
as per SRO
366. M/s Linear Tablet Melix 17-12-2013 USFDA Approved
Pharma, Plot # Rs. 12000/- MOBIC -
18, Street S-4, Each uncoated tablet Dy.No.8138 Boehringer
Industrial Zone, Meloxicam USP 7.5mg 06-10-2010 ALOXI -
Rawat. Rs.12,000/- ALSON
NSAID
Priority # 514 Manufacture
Specification Pack size & price
as per SRO
367. M/s Linear Tablet Liprazole 15mg 17-12-2013 MHRA Proof of Approved
Pharma, Plot # Rs. 12000/- approved segregated
18, Street S-4, Each oro-dispersible Dy.No.8138 Abilify –
Form 5
facility for
National tablet contains: Otsuka psychotropi
06-10-2010
Industrial Zone, Aripiprazole 15mg c
Rs.12,000/-
Rawat.
manufacturi
Dopamine Partial agonist Zedan -Surge
Priority # 483 Psychotic drug ng not
Pack size & price provided.
Manufacture as per SRO
Specification

368. M/s Reko Epafen Ophthalmic 30-12-2013 MHRA Approved
Pharmacal Solution Rs. 20,000/- approved
(Pvt.) Ltd, 13th Dy.No. 1424 Nevanac-
km, Multan Each ml contains: Form 5 Alcon
Road, Lahore Nepafenac 1mg
Pack size
Priority # 2850 Anti inflammatory Fenap –Valor
5ml  Rs. 315/-
Manufacture
Specification GMP
Compliant
section vide
inspection
report dated
30-03-2016
369. M/s Reko Olopine Ophthalmic 30-12-2013 FDA approved Approved

Pharmacal Drops Rs. 20,000/- Pataday- Alcon
(Pvt.) Ltd, 13th Dy.No. 1423
km, Multan Each ml contains: Form 5
Road, Lahore Olopatadine (as HCl) Aptadine -
USP 2mg Barrett
Pack size
Priority # 2849
5ml  Rs. 306/-
Anti inflammatory
Manufacture
Specification
370. M/s Genome Ranast 112.5mg Capsules 31-05-2013 Proof of Deferred for
Pharmaceuticals Rs. 20,000/- approval confirmatio
(Pvt.) Ltd, 16/1, Dy.No. 471
Form 5
status of n of
Phase IV, Each capsule contains:- same approval
Industrial Pranlukast (as
dosage form status by
Estate, Hattar, hemihydrate) 112.5mg
Haripur
as per pRC countries regulatory
(cysteinyl leukotriene
Priority # 2343 receptor-1 antagonist) and authorities
Manufacture specification Pakistan not and
provided. Pakistan.
371. M/s Apex Apdinir Suspension 10-06-2010 Following Deferred for
Pharmaceuticals 50mg/5ml Dy # 1158 Form 5 documents  Latest
(Pvt.) Ltd, D-21, Rs.8000/- Zaply-
Rs.12,000/-
not found in inspectio
A/1, S.I.T.E, Each 5ml of reconstituted Wislhire application n report
28-03-2014
Super Highway, suspension contains:-
Photocopy  Latest conducte
Karachi Cefdinir 50mg
inspectio d within
Pack size of 60ml n report one
Priority # 42 (Antibiotics)
& price as per pRC conducte year.
d within  confirma
one tion of
year. approval
 Proof of status by
approval referenc

status of e
same regulator
dosage y
form in authoriti
referenc es and
e Pakistan
countrie .
s and  Commit
PAKIST ment as
AN. per
 Commit decision
ment as of 251st
per RB
decision meeting.
of 251 st
 Fee
RB challan
meeting.
372. M/s Apex Danvar capsule 10-06-2010 MHRA Following Deferred for
Pharmaceuticals Dy # 1162 Form 5 approved documents  Latest
(Pvt.) Ltd, D-21, Each capsule contains:- Rs.8000/- Distaclor -
Rs.12,000/-
A/1, S.I.T.E, Cefaclor (as Flynn application n report
28-03-2014
Super Highway, monohydrate) USP
Karachi 500mg Ceclor -AGP
inspectio d within
Priority # 39 (Antibiotics) n report one
Pack size 12s  as conducte year.
USP specification
per PRC d within  Commit
one ment as
year. per
 Commit decision
ment as of 251st
per RB
decision meeting.
of 251 st
 Fee
RB challan
meeting.
373. M/s Apex Apedroxile capsule 10-06-2010 MHRA Following Deferred for
Pharmaceuticals Dy # 1162 Form 5 approved brand documents  Latest
(Pvt.) Ltd, D-21, Each capsule contains:- Rs.8000/- of Sandoz
Rs.12,000/-
A/1, S.I.T.E, Cefadroxil (as application n report
28-03-2014
Super Highway, monohydrate) USP Neucef - Sami
Karachi 500mg
inspectio d within
Priority # 33 (Antibiotics) n report one
Pack size 12s  as conducte year.
USP specification
per PRC d within  Commit
one ment as
year. per

 Commit decision
ment as of 251st
per RB
decision meeting.
of 251st  Fee
RB challan
meeting.
374. M/s Davis Tricold plus Sachet 30-07-2011 Following Deferred for
Pharmaceuticals Form 5 Flu Eze - documents  Latest
Laboratories, Each Sachet Contains Rs.8000/- Werrick
Rs.12,000/-
121, Industrial Paracetamol 500mg application n report
30-07-2013
Triangle Area, Mepyramine Maleate
 Latest conducte
Kahuta Road, 13mg
Islamabad. Pheniramine maleate inspectio d within
Pack size 12s  as n report one
13mg
per PRC conducte year.
Priority # 1228 Pseudoephedrine HCl
30mg d within  Proof of
one approval
Analgesic / Anti allergic year. status of
Manufacture  Commit same
Specification ment as dosage
per form in
decision referenc
of 251st e
RB countrie
meeting. s and
 Proof of PAKIST
approval AN.
status of  Commit
same ment as
dosage per
form in decision
referenc of 251st
e RB
countrie meeting.
s.
375. M/s Davis Tricold plus Sachet 30-07-2011 Following Deferred for
Pharmaceuticals Form 5 Flu Eze - documents  Latest
Laboratories, Each Sachet Contains Rs.8000/- Werrick
Rs.12,000/-
121, Industrial Paracetamol 500mg application n report
30-07-2013
Triangle Area, Mepyramine Maleate
 Latest conducte
Kahuta Road, 13mg
Islamabad. Pheniramine maleate inspectio d within
Pack size 12s  as n report one
13mg
per PRC conducte year.
Priority # 1228 Pseudoephedrine HCl
30mg d within  Confirm
one ation of
Analgesic / Anti allergic year. approval

Manufacture  Commit status by
Specification ment as referenc
per e
decision regulator
of 251st y
RB authoriti
meeting. es and
 Proof of Pakistan
approval .
status of  Commit
same ment as
dosage per
form in decision
referenc of 251st
e RB
countrie meeting.
s.
376. M/s Getz Daxin 30mg Tablet 30-07-2011 Approval Deferred for
Pharma (Pvt.) Form 5 priligy status of application
Ltd, 29-30, Each film coated tablet Rs.8000/-
Rs.12,000/-
dosage form on Form5D
Sector 27, contains: in Pakistan as it is not
30-07-2013
Korangi Dapoxetine not registered in
Industrial Area, Hydrochloride eq. to
provided. Pakistan
Karachi Dapoxetine…………..30
Pack size 12s  as
mg
per PRC
Priority # 1102
(SSRI)
377. M/s Allmed Pvt. Calso 28-07-2010 Phoslo by M/s Approved
Ltd. Tablet Form 5 Nabi-
(Formerly, Each tablet contains: Rs.8000/- BioPharmaceut
EverGreen Calcium Acetate B.P Rs.12,000/- ical USA
Pharmaceuticals, ….667mg eq.to 30-07-2013
Pvt. Ltd. Elemental Calcium Lophos by M/s
Plot.No.590, 169mg Pack size 10x10’s Getz Pharma
Sundar Industrial Calcium Supplement  as per PRC
Estate Lahore. (Manfacturer’s Specs)
Priorty # 196
378. M/s Allmed Pvt. Everpol 28-07-2010 Approved
Ltd. Infusion Form 5 Perfalgan by
(Formerly, Each 100ml contains: Rs.8000/- M/s B-Braun
EverGreen Paracetamol B.P…..1g Rs.12,000/- Germany
Pharmaceuticals, Analgesic / Antipytic 30-07-2013
Pvt. Ltd. (Manfacturer’s Specs) Falgan by M/s
Plot.No.590, Pack size Bosch Pharma
Sundar Industrial 1’sx100ml  as
Estate Lahore. per PRC
Priorty # 195

379. M/s Indus Parazol 25-06-2011 Approved
Pharma Karachi. Tablet Form 5 Paracetamol by
Priorty # 1197 Each tablet contains: Rs.8000/- M/s Johnsan &
Paracetamol…..500mg Rs.12,000/- Johnsan
Analgesic / Antipytic 06-06-2013 Canada
Pack size 20’s  Panadol by M/s

Rs.200/- GSK

Veterinary Routine cases :-
S/ Name and Brand Name Type of Form International Remarks / Decision

N address of status in Observation
manufacture (Proprietary name + Initial date, diary stringent s
regulatory
r / Applicant Dosage Form +
Fee including agencies
Strength)
differential fee
Demanded Price /
Pharmacological Group Pack size GMP status as
depicted in
Finished product inspection
Specification report (dated)
380. M/s Star Toltrastar Oral Solution 18-06-2013 Emicide - nawal Approved
Laboratories Dy.No.708
, 23-km, Each ml contains Form 5 Firm is GMP
Multan Toltrazuril (I.H.S) 25 mg Rs.20.000/-
compliant as
Road, per inspection
Ghung, Antibiotics Pack size of
100ml, 150ml, 500ml dated 21-09-
Lahore Manufacture
& 1000ml  2015
Specification
Priority # decontrolled
371
381. M/s Star Tilmisin Oral Solution 18-06-2013 Motil - Breeze Approved
Laboratories Dy.No.705
Multan Tilmicosin (as phosphate) Rs.20.000/-
compliant as
Road, USP 250mg per inspection
Ghung, Pack size of
100ml, 150ml, 500ml dated 21-09-
Lahore Antibiotics 2015
Manufacture & 1000ml 
Priority # Specification decontrolled
372

382. M/s Star Closan 500mg Bolus 19-04-2013 Flukinil - Approved
Laboratories Dy.No.334 Selmore
, 23-km, Each bolus contains Form 5
Clonastel (as Sodium) Rs.20.000/-
Multan Firm is GMP
Road, 500mg compliant as
Ghung, Pack size of
Glass bottle  per inspection
Lahore Anthelmintic dated 21-09-
Manufacture decontrolled
2015
Priority # Specification
372
383. M/s Star Cipvet-200 injection 31-01-2014 Floxacin - Leads To follow Rejected
Laboratories Dy.No.101 policy
Rs.20.000/-
decision on The Board
Multan Ciprofloxacin BP 200mg compliant as this also advised
Road, per inspection veterinary to issue
Glass bottle 50m  dated 21-09- formulation. show cause
Lahore Manufacture 2015
Specification decontrolled to the
Priority # companies
372 with
registered
ciprofloxaci
n.
384. M/s Star Leva 20% Oral Powder 04-07-2013 Levabak - Approved
Laboratories Dy.No.792 Attabak
, 23-km, Each gram contains Form 5
Levamisole HCl BP Rs.20.000/-
Multan Firm is GMP
Road, 200mg compliant as
Ghung, Pack size of
100gm, 500gm, per inspection
Lahore Anthelmentics dated 21-09-
Manufacture 1000gm & 2.5kg
2015
Priority # Specification
378
385. M/s Star Florfenic Oral Solution 18-06-2013 Florobak - Firm applied Approved
Laboratories Dy.No.210 Attabak on Form 5-
, 23-km, Each ml contains Form 5-D
Rs.50.000/-
D but now
Multan Florfenicol 100mg Firm is GMP product is
Road, compliant as me too and
Lahore Manufacture 100ml, 150ml, 250ml, per inspection accordingly
450ml, 1 litre dated 21-09- firm has
Specification 2015
Priority # submitted
369 Form 5.

386. M/s Star Tablet Carpropain 08-06-2013 FDA approved Stability Deferred for
Laboratories Dy.No.706 Rimadyl studies provision of
, 23-km, Each chewable tablet Form 5-D chewable tablet –
Rs.50.000/-
Multan contains Zoetis USA it is a new studies as
Road, Carprofen USP 50mg molecule to per
Ghung, Pack size  Firm is GMP
decontrolled be registered guidelines
Lahore NSAID compliant as
USP Specification in Pakistan. approved in
per inspection 251st
Priority # dated 21-09-
367 meeting.
2015
387. M/s Star Tablet Prazistar 18-06-2013 Cazitel 230/20 Stability Deferred for
Laboratories Dy.No.706 falvoured film studies provision of
, 23-km, Each film coated tablet Form 5-D coated tablet –
Rs.50.000/-
Multan contains Chanelle it is a new studies as
Road, Pyraziquantel BP 20mg Pharmaceuticals, molecule to per
Ghung, Pyrantel Pamoate BP Pack size  Ireland
Lahore 230mg
Drontal –Bayer- in Pakistan. approved in
Priority # Anthemintic UK 251st
369 Manufacture meeting.
Specification Firm is GMP
compliant as
per inspection
dated 21-09-
2015
388. M/s Star Tablet Prazistar plus 18-06-2013 Well plus Stability Deferred for
Laboratories Dy.No.711 flavoured tablet – studies provision of
, 23-km, Each film coated tablet Form 5-D Divasa Spain
Rs.50.000/-
Multan contains it is a new studies as
Road, Pyraziquantel BP 50mg Drontal plus
Pack size  molecule to per
Ghung, Pyrantel Pamoate BP flavoured tablet –
Lahore 144mg Bayer-UK
Febantel BP 150mg in Pakistan. approved in
Priority # Firm is GMP 251st
366 Anthemintic compliant as meeting.
Manufacture per inspection
Specification dated 21-09-
2015

389. M/s Star Diclavet Oral Solution 18-06-2013 Product in Deferred for
Laboratories Dy.No.711 Firm is GMP proposed confirmation
, 23-km, Each 100 ml contains Form 5-D
compliant as strength of approval
Multan Diclazuril BP 1gm Rs.50.000/-
per inspection doesn’t exist status of
Road, dated 21-09- in Pakistan same
Ghung, Anthemintic Pack size 
decontrolled 2015 and formulation
Lahore Manufacture
Specification reference by reference
Priority # countries. regulatory
370 authorities
and
Pakistan.
390. M/s Star Bamberstar Powder 18-06-2013 Flavomycin – Stability Deferred for
Laboratories Dy.No.801 Intervet-USA studies provion of
, 23-km, Each 100 gm contains Form 5-D
Rs.50.000/-
Multan Bambermycin 4gm Firm is GMP it is a new studies as
Road, compliant as molecule to per
Ghung, Antbiotics Pack size 
decontrolled per inspection be registered guidelines
Lahore Manufacture dated 21-09-
Specification in Pakistan. provided in
2015 251st RB
Priority #
380 meeting.
391. M/s Star Wormflash Deworming 18-06-2013 Product in Deferred for

Laboratories Capsules Dy.No.800 proposed confirmation
, 23-km, Form 5-D Firm is GMP
Rs.50.000/-
strength of approval
Multan Each capsule contains compliant as doesn’t exist status of
Road, Piperazine Citrate BP per inspection in Pakistan same
Ghung, 390mg Pack size 
decontrolled dated 21-09- and formulation
Lahore 2015
Anthelmintic reference by reference
Priority # Manufacture countries. regulatory
379 Specification authorities
and
Pakistan.
392. M/s Star Micostar medicated 18-06-2013 Malaseb – Bayer Stability Deferred for
Laboratories shampoo Dy.No.802 -UK studies provion of
, 23-km, Form 5-D
Rs.50.000/-
Multan Each 100ml contains Firm is GMP it is a new studies as
Road, Miconazole Nitrate BP compliant as molecule to per
Ghung, 2gm Pack size 
decontrolled per inspection be registered guidelines
Lahore Chlorhexidine Gluconate dated 21-09-
BP 2gm in Pakistan. provided in
2015 251st RB
Priority #
381 Antimicrobial meeting.
Manufacture
Specification

393. M/s Star Doxygenta Powder 18-06-2013 Gentadox 10/5, Stability Deferred for
Laboratories Dy.No.803 Agrar Holland, studies provion of
, 23-km, Each gram contains Form 5-D The Netherland
Rs.50.000/-
Multan Doxycycline Hyclate BP it is a new studies as
Road, 100mg Firm is GMP formulation per
Ghung, Gentamicin Sulphate Pack size 
compliant as to be guidelines
Lahore USP 50mg decontrolled
per inspection registered in provided in
dated 21-09- Pakistan. . 251st RB
Priority # Antibacterial
2015 meeting..
381 Manufacture
Specification
394. M/s Inshall Hepasoul Liquid 10-07-2013 Heptic Solution Approved

Pharmaceuti Each 100ml contains Dy.No.4234 by M/s Evergreen
cal L.Cartinine……5% Form-5 Pharma Lahore
Industries, Magnesium Sulphate. Rs.20,000/- Reg#072689
Plot # 2, USP…….1%
Street SS2, Sorbitol…………20% Pack size Firm is GMP
RCCI Choline Chloride 100ml,150ml,250ml,5
compliant as
Industrial BP….10% 00ml,1Liter,2.5Liter
decontrolled per inspection
area, Rawat Betain……….2% dated 04-12-
Islamabad. Inositol BP………..0.7% 2015
Hepatoprotective,
Priority # (Multivitamins. Immune
384 booster )
395. M/s Inshall Coolant Powder 10-07-2013 Acelyte water Approved

Pharmaceuti Each 1000 g contains Dy.No.4235 Soluble Powder
cal Vitamin Form-5 by M/s Decent
Industries, C……………200g Rs.20,000/- Pharma Rawat
Plot # 2, Acetyl Salicylic Reg#079821
Street SS2, Acid….67g Pack size
RCCI Calcium 30g,50g,100g,250g, Firm is GMP
Industrial Carbonate…...50g 500g,1kg,5kg,10kg,
compliant as
area, Rawat Sodium Chloride……40g 25kg
decontrolled per inspection
Islamabad. Magnesium dated 04-12-
Sulphate….40g 2015
Priority # Sodium citrate……0.7g
384 (NSAID)

Deferred cases :-
S.No Name and Brand Name Type of Form Decision of Remarks Decision
. address of (Proprietary Initial date, diary meeting of
manufactu name + Dosage Fee including Registration
rer / Form + differential fee Board
Applicant Strength) Demanded Price /
Composition Pack size
Pharmacological
Group Approval status
Finished product international /
Specification national
396. M/s Nocid 40mg/5ml Form 5 Registration Firm has Approved
Novartis Rs. 20,000/- vide Board in its 257th submitted the
Pharma Each 5 ml of Dy. No. 2629 meeting deferred prescribed fee Rs.
(Pakistan) reconstituted dated 11-12-2015 for evaluation as 20,000/- on 14-
Limited, suspension per decision of 06-2016, for form
5.
Petaro contains 250th Registration
Road, Famotidine BP Pack size of 60ml Board meeting.
Jomshoro. 40mg amber color glass
bottle
Histamine H2
receptor Famotidine
antagonist 40mg/5ml –FDA
(Manufacture Zepsin (Cirin)

Specification)
397. M/s CCL Sita-Met XR Tab Form-5-D Deferred 257th for Firm has Registration
Pharmace 50/500 Dy. No: Not clarification of submitted Board
utical Tablet mentioned NCE as per Stability Studies referred for
Each tablet contains: Dated.08-04-2013
Lahore. DRAP’s Policy conducted as per on site
Sitagliptin Rs.50,000/-
phosphate As per SRO Board decision decision of 251st verification
monohydrate eq. 10’s,14’s,30’s meeting of the of stability
to USFDA Approved. Board. data by panel
Sitagliptin…......... JANUMET XR comprising
........50mg By MERCK of Director
Metformin SHARP DOHME DTL,
HCI………..500
Peshawar,
mg
(Anti Diabetic) Lahore and
area FID,
DRAP.
Priority 2252

Lahore DRAP’s Policy conducted as per on site
monohydrate eq. 10’s,14’s meeting of the of stability
HCI……..…..100
Peshawar,
0mg
area FID,
Priority 2251 DRAP.
Lahore DRAP’s Policy conducted as per on site
monohydrate eq. 10’s,14’s meeting of the of stability
HCI……..…..100
Peshawar,
0mg
area FID,
Priority 2253 DRAP.

400. M/s CCL Urocon + Tablets Form-5-D Deferred 257th for Registration
Pharmace Tablet Dy. No: Not clarification of Board
utical Each tablet mentioned NCE as per referred for
contains: Dated.03-12-2013
Lahore DRAP’s Policy on site
Solifenacin Rs.50,000/-
succinate As per SRO Board decision verification
……….6mg 30’s of stability
Tamsulosin HCl Vesomni (UK), data by panel
(as SR MHRA comprising
pellets)…..0.4mg of Director
(Alpha-1 DTL,
adrenoceptor
Peshawar,
antagonists)
Priority 2745 Lahore and
area FID,
DRAP.
401. M/s Elko Carbo Vet Form 5-D vide Dy. Registration Firm has now Deferred for
Organizati Injection # 2670 dated Board in 258th RB submitted provision of
on 24-05-2013 meeting deferred application on following
(Private) Each ml the case and prescribed Form information/
Limited, contains:- advised to apply 5-D in which documents
Carbetocin……… Pack size –10ml, following  Stability
27 & 28, on prescribed
..0.07mg/ml 50ml, 100ml, - shortcomings data of
Sector Decontrolled Form 5-D along needs to be the
12/B, Oxytocic, antihem with required rectified :- product
North orrhagic and utero documents  Stability data as per
Karachi, tonic because same of the product guideline
Industrial drug formulation is not as per s
Area, BP Spec’s yet registered in guidelines provided
Karachi Pakistan. provided in in 251st
251st RB RB
Priority # meeting. meeting.
359  Prescribed fee  Prescribe
of Form 5-D. d fee of
Form 5-
D.
402. M/s Elko Gamocin Injection Form 5-D vide Dy. Registration Firm has now Deferred for
Organizati # 2669 dated 24- Board in 258th RB submitted provision of
on Each ml 05-2013 meeting deferred application on following
(Private) contains:- the case and prescribed Form information/
Limited, Gamithromycin… advised to apply 5-D in which documents
……..150mg/ml Pack size –10ml, following  Stability
27 & 28, on prescribed
50ml, 100ml, shortcomings data of
Sector (Antibioric). 250ml, 500ml, Form 5-D along needs to be the
12/B, 1000ml vials with required rectified :- product
North Decontrolled documents  Stability data as per
Karachi, because same of the product guideline
Industrial formulation is not as per s
Area, yet registered in guidelines provided

Karachi Pakistan. provided in in 251st
251st RB RB
Priority # meeting. meeting.
361  Prescribed fee  Prescribe
of Form 5-D. d fee of
Form 5-
D.
403. M/s UDL TENZOLID Form 5 Registration Photocopies of Approved.

Pharmaceut 100mg/5ml 20,000/- Board COA , GMP Firm will
icals, Plot # granules Dy. No. 4278 deferred the certificate. provide
E-44& E- for oral (07/07/2015) case in 258th legalized
45, North suspension meeting of RB for GMP, CoA,
Western stability data
Pellet fee Rs. provision of
Industrial of Zone IVA
Zone, Port Each 5ml of 80,000/- vide Dy Source of and
Qasim reconstituted # nil dated 24-05- coated taste Chairman,
Authority, suspension 2016 masked RB will
Karachi. contains: linezolid permit
Linezolid BP Pack of pellets along issunce of
100 mg 10’s and 30’s as with GMP registration
per SRO certificate of letter.
(Antibiotics) the source,
USP FDA approved Stability data
Specification Avodart (GSK) and required
fee if source
Source of Avodart (GSK) is outside of
pellets:- Pakistan.
Benovo Labs
private limited,
Plot # 97 & 98,
Kolhar
Industrial Area,
Bidar, Karnatka,
India
404. M/s Saniplast Aqua Form-5 Deferred in 257th Reply of the firm Approved
Uniferoz Bandage First Aid Dy. No: 1442 RB meeting mentioned below
PVT. Ltd. Bandage Dated. 21.06.2012 for clarification for
32/8 Sector Rs.8,000/- registration of the
15, Korangi Each Bandage Dated.05.09.2013 same strength /
Industrial contains: Rs.12000/- composition.
Area, Polyurethane (PU) Rs.41/10’s
Karachi. Tape (25x72mm),
(1840) Bezalkonium 40.50/10’s
Chloride Pad (38x38mm)
………………..0. 40.57/10’s,

5%w/w. (5’s x25x72mm &
5’sx38x38mm)
(First Aid 40.57/20’s,
Bandage) (10’s x25x72mm &
(Mfg. specs) 10’s x38x38mm)
BAND-AID
(Johnson &
Johnson) made in
Brazile, distributed
in canada.
Nexcare Clear by
3M consumer
Health Care USA.
Saniplast Ultra first
aid Bandage (with
Poluethylene Base)
by M/sUniferoz.
 It is water proof bandage, thus the wound area is protected from getting wet. 
 It completely seals the applied area on the skin and help protect the small wound from dust and germs.
 The consumer will appreciate availability of this new improved variant once it is available in Pakistan,
as this is available abroad, and they do purchase this vairiant abroad.
 Introduction of this variant will help in introducing this new improved first aid bandages for domestic
and export markets, improve utilization of our capacity and adapt modern technology.
They further explained that Board has already granted export registration of saniplast aqua bandage. However
when we apply for registration abroad they require free sale certificate in the country of manufacturer, which
they couldn’t provide to importing country due to non-registration in Pakistan.
405. -do- Dermapore Non Form 5 Deferred for the Reply of the
Woven Fabric 10 cmx10m confirmation of firm
Surgical Tape for 5 cm x 10m approval status in mentioned
(Surgical 2.5 cm x10 reference countries. below
Dressing & Demanded price
Bandage) has not been
mentioned
Rs.8000/-
(27/07/2010)
Rs.12,000/-
(23/07/2013)
Fee challans are
duplicate
Total
Rs.20,000/-
Dy. No. not
available /
Duplicate
dossier
GMP
inspection

report dated
15-07-2014.
Overall GMP
compliance
level rated as
good.
 We already manufacture Dermapore Non Woven Paper Surgical Tapes for domestic and export Registration
markets and has registration from DRAP. Non-Woven fabric surgical tapes would be manufactured Board
by using the same manufacturing capacity to introduce a new varient. referred the
 Dermapore Non Woven Fabric Surgical tapes export registration was granted by board earlier, now proposed
we are seeking registration to sell the same product in domestic market for utilization of capacity and product for
modern technology. comments of
 For export registrations in foreign countries we required free sale certificate which can only be ECMD.
applied when we have local registration.
 Non registered similar tapes are already being used in local hospitals. We on the other hand are
seeking registration to manufacture a better product locally by utilizing our hand are seeking
registration to manufacture a better product locally by utilizing our ideal capacity, and meeting the
demand of the market.
406. Importer Gentadox Water Form 5 with fee Rs The Board deferred Registration
M/s. Soluble powder 100,000/- vide Dy. the case for Board
UM # 411 dated 13-05- provision of rejected the
Enterpri Each gm contains:- 2013 approval status of proposed
ses, Gentamycin Sulphate same formulation formulation,
Karachi, 160mg equivalent to in Pakistan and being ir-
18-C, 3rd Gentamycin 100mg Pack size of reference rational.
floor, Doxycycline HCl 100gm, 500gm, regulatory
Dolmen 100mg 1kg & 5kg  authorities.
Estate decontrolled
Building Antibiotic
, Block Specifications:- Zygosis-Nigeria
7-8, Manufacturer Jovet-Jordan
Shaheed
-e-
Millat Not yet registered
Road, in Pakistan
Karachi
Manufa
cturer:
M/s.
Arab
Veternia
ry
Industri

es CO,
(AVICO
), P.O
Box
150906
Amman,
11115,
Jordan
407. Importer Diclacox Liquid Form 5 with fee Rs The Board deferred Registration
M/s. 100,000/- vide Dy. the case for Board
UM Each ml contains:- # 380 dated 08-05- provision of deferred the
Enterpri Diclazuril 10mg 2013 approval status of case for
ses, same dosage form provision of
Karachi, Anticoccidal in reference following
18-C, 3rd Specifications:- Pack size of 100ml, regulatory documents/i
floor, Manufacturer 500ml, 1L & 5L  authorities and in nformation:-
Dolmen decontrolled Pakistan.  Product
Estate Developm
Building ent data in
, Block however in powder liquid
7-8, from available. dosage
Shaheed Reg # 021258 form.
-e-  Stability
Millat data for
Road, real time
Karachi studies
and
Manufa accelerate
cturer: d time
M/s. studies.
Arab  Complete
Veternia master
ry formulatio
Industri n along
es CO, with
(AVICO active and
), P.O inactive
Box ingrdients
150906 .
Amman,
11115,
Jordan
Deferred cases of new licensed manufacturers

408. M/s Ospra capsule 20mg Form 5 Deferred in 249th Firm has now Approved
Linta 17-04-2015 RB meeting for change the source
Pharmac Each Capsule (977) submission of of pellets and
euticals Contains: Rs.1,00,000/- legalized GMP submitted new
(Pvt.) Omeprazole As per SRO/ certificate of source documents
Ltd, Plot (enteric coated pellets) 2 x 7’s pellet’s as under:-
# 3, eq. to Omeprazole... manufacturer, COA Source of
Street # 20mg BNF: Losec and stability studies Omeprazole
S-5, (AstraZeneca) data of pellets. ECP pellets
National (Proton Pump 22.5%:-
Industri Inhibitor) RISEK 20mg M/s Vision
al Zone, (USP Spec.s) Capsule Pharmaceuticals,
Rawat Getz Pharma (Pvt.) Plot # 22-23,
Ltd Industrial
{Source of pellets: M/s Triangle, Kahuta
. Lee Pharma Ltd., Sy. Grant For Road, Islamabad.
No. 199, Plot No. 3 & registration of
4, D.No. 5-9-265/1 & drugs of new
2, Rajeevgandhinagar, license dated 02-
Prasanthinagar I.E, 04-2015
Kukatpally, Ranga
Reddy District,
Telangana State, India}
409. -do- Ospra capsule 40mg Form 5 Deferred in 249th Firm has now Approved
17-04-2015 RB meeting for change the source
Each Capsule (978) submission of of pellets and
Contains: Omeprazole Rs.1,00,000/- legalized GMP submitted new
(enteric coated pellets) As per SRO/ certificate of source documents
eq. to Omeprazole... 2 x 7’s pellet’s as under:-
40mg manufacturer, COA Source of
BNF: Losec and stability studies Omeprazole
(Proton Pump (AstraZeneca) data of pellets. ECP pellets
Inhibitor) 22.5%:-
(USP Spec.s) RISEK 40mg M/s Vision
Capsule Pharmaceuticals,
{Source of pellets: M/s Getz Pharma (Pvt.) Plot # 22-23,
. Lee Pharma Ltd., Sy. Ltd Industrial
No. 199, Plot No. 3 & Triangle, Kahuta
4, D.No. 5-9-265/1 & Grant For Road, Islamabad.
2, Rajeevgandhinagar, registration of
Prasanthinagar I.E, drugs of new
Kukatpally, Ranga license dated 02-
Reddy District, 04-2015
410. -do- Rush capsule 20mg Form 5 Deferred in 249th Firm has now Approved
17-04-2015 RB meeting for change the source with change
Each Capsule (984) submission of of pellets and of brand
Contains:- Rs.1,00,000/- legalized GMP submitted new name.
Esomeprazole( as As per SRO/ certificate of source documents
Esomeprazole 2 x 7’s pellet’s as under:-

magnesium trihydrate manufacturer, COA Source of
enteric NEXIUM Capsule and stability studies Esomeprazole
coated pellets) (USP) (AstraZeneca) data of pellets as Mg ECP pellets
…20 mg per Zone IVA. 22.5%:-
E-CAP 40mg M/s Vision
(Proton Pump Capsules Pharmaceuticals,
Inhibitor) ((Brookes Plot # 22-23,
(USP Spec.s) Pharmaceuticals Industrial
(Pvt) Limited)) Triangle, Kahuta
{Source of pellets: M/s Road, Islamabad.
. Lee Pharma Ltd., Sy.
No. 199, Plot No. 3 & Grant For
4, D.No. 5-9-265/1 & registration of
2, Rajeevgandhinagar, drugs of new
Prasanthinagar I.E, license dated 02-
Kukatpally, Ranga 04-2015
Reddy District,
411. -do- Rush capsule 40mg Form 5 Deferred in 249th Firm has now Approved
17-04-2015 RB meeting for change the source with change
Each Capsule (985) submission of of pellets and of brand
contains Rs.1,00,000/- legalized GMP submitted new name.
Esomeprazole( as As per SRO/ certificate of source documents
Esomeprazole 2 x 7’s pellet’s as under:-
magnesium trihydrate manufacturer, COA Source of
enteric NEXIUM Capsule and stability studies Esomeprazole
coated pellets) eq. to (AstraZeneca) data of pellets as Mg ECP pellets
Esomeprazole…40 mg per Zone IVA. 22.5%:-
E-CAP 40mg M/s Vision
(Proton Pump Capsules Pharmaceuticals,
Inhibitor) (Brookes Plot # 22-23,
(USP Spec.s) Pharmaceuticals Industrial
(Pvt) Limited) Triangle, Kahuta
{Source of pellets: M/s Road, Islamabad.
. Lee Pharma Ltd., Sy.
No. 199, Plot No. 3 & Grant For
4, D.No. 5-9-265/1 & registration of
2, Rajeevgandhinagar, drugs of new
Prasanthinagar I.E, license dated 02-
Kukatpally, Ranga 04-2015
Reddy District,

412. -do- Votsa capsule 30mg Form 5 Deferred in 249th Firm has now Approved
17-04-2015 RB meeting for change the source
Each Capsule (986) submission of of pellets and
Contains: Lansoprazole Rs.1,00,000/- legalized GMP submitted new
(enteric coated pellets) As per SRO/ certificate of source documents
eq. to Lansoprazole 2 x 7’s pellet’s as under:-
(USP) ... 30mg manufacturer, COA Source of
FDA: Prevacid and stability studies Lansoprazole
(Proton Pump (Novartis data of pellets. ECP pellets
Inhibitor) Pharmaceuticals) 22.5%:-
(USP Spec.s) M/s Vision
{Source of pellets: M/s Inhibitol 30mg Pharmaceuticals,
. Lee Pharma Ltd., Sy. Capsule Plot # 22-23,
No. 199, Plot No. 3 & (Highnoon Industrial
4, D.No. 5-9-265/1 & Laboratories Triangle, Kahuta
2, Rajeevgandhinagar, Limited) Road, Islamabad.
Prasanthinagar I.E,
Kukatpally, Ranga Grant For
Reddy District, registration of
Telangana State, India} drugs of new
license dated 02-
04-2015
413. M/s Montilak 4mg sachet Form-5 Deferred in 244th All shortcomings Approved
Hamaz 18-2-2014 RB meeting for rectified.
Pharmac Each sachet contains:- Dy # 619 R&I clarification of
euticals granules of Rs.20,000/- manufacturing
(Pvt.) Montilukast (as process for
Ltd, 13- sodium) 4mg Rs.225.00/14‟s granules.
km, sachet
Bosan Leukotriene receptor
Road, antagonist MHRA approved
Luftaba Manufacture
d, Specification
Multan
Deferred cases of pendency list
414. M/s Deproset Capsule Form 5 with fee Rs. The Board deferred Firm has Approved
Himont 20mg 20,000/- vide Dy. the case in 258th submitted source
Pharmac # 592 dated 06-09- RB meeting, for of pellets as
euticals Each capsule contains:- 2013 provision source of under:-
(Pvt.) Duloxetine HCl enteric pellets along with Source of
Ltd, 17- coated pellets eq. to Pack size relevant documents Duloxetine HCl
km, Duloxetine 20 mg 14’s  Rs.447/- ECP 19.0%
Ferozpu M/s Vision
r Road, SSRI Cymbalta-Eli Lilly- Pharmaceuticals,
Lahore Manufactures FDA Plot # 22,
specification Industrial
Priority Llario-Wilshire Trinagle, Kahuta
# 2655 Source of pellets:- Road, Islamabad.

Himont 30mg 20,000/- vide Dy. the case for submitted source
Pharmac # 591 dated 21-10- provision source of of pellets as
euticals Each capsule contains:- 2013 pellets along with under:-
(Pvt.) Duloxetine HCl enteric relevant Source of
Ltd, 17- coated pellets eq. to documents. Duloxetine HCl
km, Duloxetine 30 mg Pack size ECP 19.0%
Ferozpu 10’s  Rs.415/- M/s Vision
r Road, SSRI Pharmaceuticals,
Lahore Manufactures Cymbalta-Eli Lilly- Plot # 22,
specification FDA Industrial
Priority Trinagle, Kahuta
# 2654 Source of pellets:- Llario-Wilshire Road, Islamabad.
Himont 60mg 20,000/- vide Dy. the case for submitted source
Pharmac # 591 dated 21-10- provision source of of pellets as
euticals Each capsule contains:- 2013 pellets along with under:-
(Pvt.) Duloxetine HCl enteric relevant Source of
Ltd, 17- coated pellets eq. to documents. Duloxetine HCl
km, Duloxetine 60 mg Pack size ECP 19.0%
Ferozpu 10’s  Rs.415/- M/s Vision
r Road, SSRI Pharmaceuticals,
Lahore Manufactures Cymbalta-Eli Lilly- Plot # 22,
specification FDA Industrial
Priority Trinagle, Kahuta
# 2654 Source of pellets:- Llario-Wilshire Road, Islamabad.
417. M/s Lyta 40mg Capsule Form-5-D Deferred for Firm has rectified Approved
Getz Dy. No: 114 Balance fee of form all shortcomings.
Pharma, Each capsule contains: dated. 19.02.2011 5 D,  Product is
29- Enteric coated pellets Rs.15,000/- Legalized already
30/27, of Duloxetine HCl eq 19.09.2013 documents of the registered in
Korangi to Duloxetine………. Rs.5,000/- source and Pakistan.
Industri 40mg Rs. 645/14’s, Fee for source.  Firm
al Area, 925/20’s Stability studies as submitted
Karachi (Selective serotonin per 251st meeting of fresh Form 5.
Norepinephrine Duloxetine 20mg & RB.  Firm has
2053 reuptake inhibitor) 40mg gastric submitted
(Mfg. Specification) resistant capsules legalized
Duloxetine is indicated (Consilient Health documents of
for women for the Ltd) MHRA GMP and free
treatment of moderate sale certificate
to severe stress urinary Dulan –Hilton of Source of
incontinence. Reg# 067169 Duloxetine
Delayed
released
pellets
17.65% w/w:-
M/s Alphamed
Formulations Pvt
Ltd, Sy. No. 225,

Sampanhole
Village,
Shameerpet
Mandal, Ranga
Reddy District
500 078,
Telangana state,
India
418. M/s Lexxel Tablet Form 5 Deferred 254th RB All shortcomings Approved
Pharmac Dy No.1166 for rectified.
are Labs Each film coated tablet Rs.8000 dated 28-  Raw material and
(Pvt) contains:- 12-2011 & Rs. finished product
Ltd, Escitalopram Oxalate 12,000 dated 31- specifications
129/1, USP eq.to 07-2013. need to be
Industri Escitalopram 20mg As per SRO submitted.
al  Outline of
Estate, Anti-depressant MHRA Cipralex manufacturing
Kotlakh USP Specification 20mg f/c tablet method needs to
pat, Cipralex 20mg by be provided.
Lahore. M/s Lundbeck  Description of
1462 the dosage form
is not provided.
 Fresh inspection
require to be
submitted.
419. M/s Reevo .Form5 Deferred 244th for Deferred for

Allmed Injection 2.Routine confirmation of correct
Pvt. Each ml contains: 3.Rs.5mlx10‟s/ As pharmacological pharmacolog
Ltd. Levocarnitine…… per SRO group as applied by ical group
(Former ……..200 mg 4.23-08-2010 firm. and
ly, 4.Anti infective Rs.8000/- submission
EverGre systematic 11-10-2012 of stability
en Rs.12,000/- data as per
Pharmac 251st RB
euticals, FDA: Carnitor meeting
Pvt. Ltd. Kefei Injection by
Plot.No. M/s RG Pharma
590,
Sundar
Industri
al
Estate
Lahore.
420. -do- Metoril 1.Form5 Deferred 244th for Registration
Tablet 2.Routine confirmation of Board
Each tablet contains: 3.100‟s/As per international deferred the

Nitrogen SRO availability and case for
Contents…36mg 4.06-08-2010 facilty provision of
Calcium .0.5gm Rs.8000/- for processing of complete
Aminoacids 11-10-2012 nitrogen master
Rs.12,000/ preparations formulation
and
Ketosteril by M/s
confirmation
Fresenius Kabi
of approval
Pharma Germany.
status in
Ketosteril by M/s Pakistan
Medipak Pharma
DDC PEC-I Dr. Hafsa Karam Ellahi
Sr. No Name and Brand Name Type of Form Remarks on the Remarks by Decision
address of (Proprietary name + formulation (if any) Evaluator
manufacturer Dosage Form + Initial date, diary including /Decision
/ Applicant Strength) International status in
Composition Fee including stringent drug
Pharmacological differential fee regulatory agencies /
Group Demanded Price authorities
Finished product / Pack size Me-too status
Specification GMP status as
depicted in latest
inspection report (with
date) by the Evaluator
421. M/s Irza Dephan Syrup Form 5 International availability Deferred in 255th Deferred
Pharma (Pvt) Each 5ml contains: Dairy No. 705 not confirmed meeting of DRB for
Ltd. 10.2 K.M Dextromethorphan dated 04.10.11 De xtromethrphan  for latest confirmatio
Lahore – HBr ….13.5mg Rs.8,000/- HBr 13.5 mg of n of
Sheikhupura (Antitussive) dated 29.07.2013 Neutropharma cGMP
approval
Road, P.O.Kot Protocol Applied: USP Rs.12,000/- Last GMP inspection inspection
Abdul Malik, As per SRO was conducted on 28- status by
report. reference
Distt: 120ml 04-2014
Sheikhupura. regulatory
1378  availability authorities
in SRA is
not
confirmed.
Now the firm has

submitted latest
cGMP report
dated 21-03-2016.

422. M/s Irza Dephan Syrup Form 5 International availability Deferred in 255th Deferred
Pharma (Pvt) Each 5ml contains: Dairy No. 706 not confirmed meeting of DRB for
Ltd. 10.2 K.M Dextromethorphan dated 04.10.11  for latest confirmatio
Lahore – HBr …..10mg Rs:8,000/- BUCKLEYS JACK & n of
Sheikhupura Chlorpheniramine dated 29.07.2013 JILL (Pacific cGMP
approval
Road, P.O.Kot Maleate……2mg Rs.12,000/- Phararmaceutical inspection
Abdul Malik, (Antitussive / As per SRO status by
report. reference
Distt: Antihistamine) 120ml Last GMP inspection
Sheikhupura. Protocol Applied: USP was conducted on 28- regulatory
1379 04-2014  availability authorities
in SRA is
not
confirmed.
Now the firm has

submitted latest
cGMP report
dated 21-03-2016.
423. M/s Irza R-Din Injection Form 5 International availability Deferred in 255th Approved
Pharma (Pvt) Each 2ml contains: Dairy No. 4831 FDA approved Zantac meeting of DRB
Ltd. 10.2 K.M Ranitidine HCl dated 28.04.11 Eq to 25MG Ranitidine  for latest
Lahore – equivalent to Rs.8,000/- Base/Ml
Sheikhupura Ranitidine………50m dated 29.07.2013 Concordia Pharms Inc cGMP
Road, P.O.Kot g Rs.12,000/- inspection
Abdul Malik, (H 2 Blocker) As per SRO report.
Distt: 5’s
Sheikhupura.
Now the firm has
1010
submitted latest
cGMP report
dated 21-03-2016.
424. M/s Irza Irzaline Injection Form 5 International availability Deferred in 255th Approved
Pharma (Pvt) Each 1ml contains: Dairy No. 4829 FDA: Lincocin meeting of DRB
Ltd. 10.2 K.M Lincomycin dated 28.04.11 Lincomycin HCl Eq.  for latest
Lahore – Hydrochloride Rs.8,000/- 300mg base per ml
Sheikhupura equivalent to dated 29.07.2013 (Pharmacia and Upjohn) cGMP
Road, P.O.Kot Lincomycin………300 Rs.12,000/- inspection
Abdul Malik, mg As per SRO Lincocin (pfizer report.
Distt: (Lincosamide) 12’s laboratories
Sheikhupura. ltd. (Lincomycin HCl),
Now the firm has
1008 equivalent to
submitted latest
Lincomycin……..300m
cGMP report
g
dated 21-03-2016.
Last GMP inspection
was conducted on 28-
04-2014
425. M/s Irza Irzaline Injection Form 5 International availability Deferred in 255th Approved
Pharma (Pvt) Each 2ml contains: Dairy No. 4827 FDA: Lincocin meeting of DRB
Ltd. 10.2 K.M Lincomycin dated 28.04.11 Lincomycin HCl Eq.  for latest
Lahore – Hydrochloride Rs.8,000/- 300mg base per ml
Sheikhupura equivalent to dated 29.07.2013 (Pharmacia and Upjohn) cGMP
Road, P.O.Kot Lincomycin…. 600mg Rs.12,000/- Lincocin (pfizer inspection
Abdul Malik, (Lincosamide) As per SRO laboratories

Distt: 12’s ltd. (Lincomycin HCl), report.
Sheikhupura. equivalent to
1011 Lincomycin………600 Now the firm has
mg/2ml submitted latest
Last GMP inspection cGMP report
was conducted on 28- dated 21-03-2016.
04-2014
426. M/s Irza Asmolin Injection Form 5 Aminophylline Deferred in 255th Approved
Pharma (Pvt) Each ml contains: Dairy No. 618 25mg/ml meeting of DRB with
Ltd. 10.2 K.M Aminophylline……..2 dated 28.05.11 Mercury pharma UK  for latest change of
Lahore – 5mg Rs.8,000/- Aminophylline Hydrate
Sheikhupura (Antiasthmatic) dated 29.07.2013 25mg/ml Sol for Inj of cGMP brand
Road, P.O.Kot Rs.12,000/- USFDA inspection name
Abdul Malik, As per SRO Aminophylline report.
Distt: 5’s 25mg/ml
Sheikhupura. GD SEARLE LLC
1099 (Discontinued)  Change of
Aminophylline name
25mg/ml of LCPW
Last GMP inspection Now the firm has
was conducted on 28- submitted latest
04-2014 cGMP report
dated 21-03-2016.
427. M/s Irza Jantolin Injection Form 5 International availability Deferred in 255th Approved
Pharma (Pvt) Each 1ml contains: Dairy No. 4828 Ventolin Injection meeting of DRB with
Ltd. 10.2 K.M Salbutamol Sulphate dated 28.04.11 (0.5mg) in 1ml  for latest change of
Lahore – equivalent to Rs.8,000/- Glaxo Wellcome UK
Sheikhupura Salbutamol…. 0.5mg dated 29.07.2013 Ltd cGMP brand
Road, P.O.Kot (Selective Beta 2 Rs.12,000/- Me too : ventral inspection name
Abdul Malik, Agonist) As per SRO Akson report.
Distt: 5’s
Sheikhupura.
1007 Last GMP inspection  Change of
was conducted on 28- mame
04-2014
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
428. M/s Irza I-Menate Injection Form 5 DIMENHYDRINATE Deferred in 255th Approved
Pharma (Pvt) Each 1ml contains: Dairy No. 4825 50MG/ML meeting of DRB
Ltd. 10.2 K.M Dimenhydrinate…….5 dated 28.04.11 INJECTION OF  for latest
Lahore – 0mg Rs.8,000/- FRESENIUS KABI
Sheikhupura (Antihistamine) dated 29.07.2013 USFDA cGMP
Road, P.O.Kot Rs.12,000/- inspection
Abdul Malik, As per SRO Gravinate injection report.
Distt: 25’s Searl pharma
Sheikhupura. Last GMP inspection
Now the firm has
1012 was conducted on 28-
submitted latest
04-2014
cGMP report
dated 21-03-2016.

429. M/s Irza I-Cobal Injection Form 5 Methycobal amine of Deferred in 255th Approved
Pharma (Pvt) Each 1ml contains: Dairy No. 4824 Eisai Co. Ltd. Japan meeting of DRB with
Ltd. 10.2 K.M Mecobalamin…….500 dated 28.04.11 Mabil Injection (Sami  for latest change of
Lahore – mcg Rs.8,000/- Pharma, Karachi).
Sheikhupura (Coenzyme type dated 29.07.2013 Last GMP inspection cGMP brand
Road, P.O.Kot vitamin B12) Rs.12,000/- was conducted on 28- inspection name
Abdul Malik, As per SRO 04-2014 report.
Distt: 10’s
Sheikhupura.
1013  Change of
name
Now the firm has
submitted latest
cGMP report
dated 21-03-2016.
Import Case of M/s Atco Pharma was deferred in 255th meeting of RB.
Sr. No Name and Brand Name Type of Form Remarks on the Remarks by Decision
address of (Proprietary name + formulation (if Evaluator
manufacture Dosage Form + Initial date, diary any) including /Decision
r / Applicant Strength) International
Composition Fee including status in stringent
Pharmacological differential fee drug regulatory
Group Demanded Price agencies /
Finished product / Pack size authorities
Specification Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
430. Atco Micopirox, Nail Lacquer Form 5-A Penlac,8% Deferred in 255th Approved as per
pharma Cyclopirox 8mg/100g Rs. 15000 dt 19- Topical solution of meeting for the Import Policy for
BP Specification 04-2011 (Valeant following reasons; Finished Drugs
Internationa
l
Rs. 85000 dt 04- Bermuda)  CPP issued on
06-2013 USFDA
(PVT.)LTD Rs. 600 Feb 2011 and
B-18, is valid for 12
S.I.T.E, months.
Karachi-
75700  Last GMP
Name and certificate was
address of issued on Nov
Manufactur 2010 and is in
er;
local language.
Laboratorio
Pablo Latest

Cassar’a legalized
S.R.L Certificate
Carhue with English
1096.
translation
(C.P.1408)
City: required.
Buenos
 Sole
Aires
Country: agreement of
Argentina Laboratory
Pablo Cassara
52 with Atco is
valid till
December
2015.
Extension in
the agreement
is required.

Routine Cases.
S. No Name and Brand Name Type of Form Remarks on the Remarks by Decision
address of (Proprietary name + formulation (if Evaluator
manufacture Dosage Form + Initial date, diary any) including /Decision
r / Applicant Strength) International
Composition Fee including status in
Pharmacological differential fee stringent drug
Group Demanded Price regulatory
Finished product / Pack size agencies /
Specification authorities
Me-too status
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
M/s. Friends Bactriol Form 5 Avelox I.V by Approved
431. Pharma (Pvt) infusion Dy.No.561 M/s. Bayer Inc.
Limited, Each 250ml contains: 28-05-2011 US FDA
31Km Moxifloxacin……400m Rs:8,000/- Avilox Infusion
Ferozpure g 14.05.2013 by M/s. Baeyer
Road, Lahore Rs.. 12000/- (Pvt) Limited,
1092 (Anti-biotic) As per SRO Karachi
432. M/s. Friends Cipfen Form 5 Ciprofloxacin Approved

Pharma (Pvt) infusion Dy.No.522 2mg / ml by
Limited, Each 100ml contains: 03-05-2011 Pharmathen
31Km Ciprofloxacin …200mg Rs:8,000/- MHRA
Ferozpure 14.05.2013
Road, Lahore (Anti-biotic) Rs.. 12000/- cipesta Infusion
1091 As per SRO by M/s. Getz
Pharma
433. M/s Zylofixim Capsule Form 5 Applied Applied Deferred for

Remington Oral Capsules Dy.No.3898 formulation is formulation is confirmation
Pharma Each Capsule contains: 28-03-2011 not available in not available in of approval
Lahore Cefixime Trihydrate Rs:8,000/- reference reference SRA’s. status by
846 U.S.P equivalent to Dy. No. 9276 SRA’s. The firm also
reference
Cefixime…..200mg 30.07.2013 Cefim by M/s fails to provide
(Antibiotic). Rs.. 12000/- Getz Pakistan the same.
regulatory
Manufacturer’s Leader Price authorities
Specification

434. M/s Nilol 10mg Form 5 Bystolic Tablet Approved
Remington Tablet Dy.No.136 of Forest Labs
Pharma Each tablet contains: 23-2-2016 US FDA
Lahore Nebivolol Hcl eq to Rs:20,000/-
1544 Nebivolol……10mg As per PRC ByscardTablet
Beta Blocker As per PRC Searle Pakistan
Manufacturer’s
Specification
435. M/s Malfan 80/480 Form 5 Applied Applied Deferred for

Remington Dispersible Dy.No.1500 formulation is formulation is confirmation
Pharma Oral dispersible Tablet 04-8-2011 not available in not available in of approval
Lahore Each dispersible tablet Rs:8,000/- reference reference SRA’s. status by
853 contains: Dy. No. 9296 SRA’s. The firm also
reference
Artemether……80mg 30.07.2013 Alar once fails to provide
Lumefantrine……480m Rs12000/- Dispersible by the same.
regulatory
g Leader Price M/s Searle authorities /
(Anti Malarial) Pharma WHO
Manufacturer’s
Specification
436. M/s Malfan 40/240 Form 5 Applied Applied Deferred for

Remington Dispersible Dy.No.1501 formulation is formulation is confirmation
Pharma Oral Tablet 04-8-2011 not available in not available in of approval
Lahore Each tablet contains: Rs:8,000/- reference reference SRA’s. status by
852 Artemether……40mg Dy. No. 9289 SRA’s. The firm also
reference
Lumefantrine……240m 30.07.2013 Alar once fails to provide
g Rs12000/- Dispersible by the same.
regulatory
Leader Price M/s Searle authorities
(Anti Malarial) Pharma /WHO
Manufacturer’s
Specification
437. M/s Nebra-D Form 5 Applied Applied Rejected

Remington Ophthalmic suspension Dy.No.1500 formulation is formulation is being
Pharma Each ml contains: 04-8-2011 not available in not available in
Lahore Tobramycin Rs:8,000/- reference reference SRA’s.
irrational
945 U.S.P……3.0 mg Dy. No. 9296 SRA’s. The firm also formulation
Dexamethasone 30.07.2013 Me too status is fails to provide and not
U.S.P……1.0mg Rs12000/- not confirmed the same. approved by
Boric Acid B.P….5mg Leader Price ant
Manufacturer’s
Specification
reference
(antibacterial, regulatory
corticosteroid) authoritity
Manufacturer’s
Specification

438. M/s Remflox 750 Form 5 Levaquin Tablet Shelf life Approved
Remington Oral Tablet Dy.No. of Janssen provided by the
Pharma Each film coated tablet 21-05-2012 Pharms firm is three years
Lahore contains: Rs:8,000/- US FDA whereas 2 years
1818 Levofloxacin Dy. No. Leflox by M/s are allowed by the
Hemihydrates eq. to 30.07.2013 Getz Pharma Board.
Levofloxacin U.S.P Rs12000/-
(Antibiotic, quinolones) Leader Price
Manufacturer’s
Specification
439. M/s Zincure Form 5 Applied Deferred for Deferred for

Remington Oral Syrup Dy.No. 5853 formulation is opinion/commen opinion/com
Pharma Each 5ml contains: 29-06-2012 not available in ts of ments of
Lahore Zinc Sulphate Rs:8,000/- reference WHO as per WHO as per
842 Monohydrate U.S.P 30.07.2013 SRA’s. decision of the
decision of
equivalent to Elemetal Rs12000/- board in 250th
Zinc………20mg Leader Price meeting. Dosage the board in
recommendation 250th
(Zinc Supplement) (UNICEF/ meeting.
Manufacturer’s WHO): Tablets
Specification may contain
either 10 or 20 mg
of zinc and the
concentration of
zinc in oral
solutions may be
10mg/5mL.
Decisions about
the best strength
to be used should
depend on better
adherence to
treatment by
patient, taking
into consideration
other issues as
well, such as
price, medicine
delivery, and
duration of
treatment (10- or
14-day treatment).
Preferably, in any
given country,
only one strength
of tablets or oral
solution should be
available to avoid
dosing errors. If
10-mg zinc tablets
are chosen, it will
mean that older
children will have
to take two tablets

each day; if 20mg
zinc tablets are
chosen, it will
mean that for
younger infants
only half a tablet
will be given each
day and therefore
tablets will have
to be scored to
facilitate this.
With oral
solutions, because
it is difficult to
accurately
measure half a
teaspoon of
solution, it is
recommended that
oral solution of
zinc contain 10mg
of elemental zinc
per 5 mL, that is
to say per one
teaspoon. It
means that infants
below 6 months
of age will receive
one teaspoon,
while older
children will need
2 teaspoons of
oral solution per
day. (Ref:
UNICEF/ WHO)
440. M/s Remisole-P Syrup Form 5D Applied Applied Deferred for
Remington Each 5ml contains: Dy.No. 5852 formulation is formulation is confirmation
Pharma Ammonium Chloride 29-06-2012 not available in not available in of approval
Lahore B.P….100mg Rs:15,000/- reference reference SRA’s. status by
841 Sodium Citrate 30.07.2013 SRA’s. The firm also
reference
B.P….60mg Rs35000/- fails to provide
Chlorpheniramine Rs. 45/60ml the same.
regulatory
Maleate B.P……2mg Rs. 65/120ml authorities
Phenylephrine HCl Rs. 200/450ml and Pakistan
B.P…..5mg
Menthol B.P…..1.0mg
(Expectorant)
Manufacturer’s
Specification

441. M/s Moxidex Form 5 Applied Applied Deferred for
Remington Each ml contains: Dy.No. 1465 formulation is formulation is confirmation
Pharma Moxifloxacin 23-04-2012 not available in not available in of approval
Lahore Hydrochloride B.p Rs:8,000/- reference reference SRA’s. status by
840 Equivalent to 30.07.2013 SRA’s. The firm also
reference
Moxifloxacin…..5mg Rs 12,000/- Oxcin-D by M/s fails to provide
Dexamethasone Sodium Leader Price Atco Pharma the same.
regulatory
Phosphate U.S.P eq. to authorities
Dexamethasone
Phosphate…..1mg
(Antibiotic &
Corticosteroid)
Manufacturer’s
Specification
442. M/s Moxear-Pain otic drops Form 5 Applied Applied Deferred for
Remington Each ml contains: Dy.No. 1465 formulation is formulation is confirmation
Pharma Moxifloxacin HCL B.P 23-04-2012 not available in not available in of approval
Lahore Equivalent to Rs:8,000/- reference reference SRA’s. status by
791 Moxifloxacin…..5mg 30.07.2013 SRA’s. The firm also
reference
Lignocaine HCL B.P Rs 12,000/- Me too status is fails to provide
equivalent to Lignocaine Leader Price not confirmed the same.
regulatory
base ……50mg authorities
(Antibiotic and local and pakistan
Anaesthetic)
Manufacturer’s
Specification
443. M/s Valpin-H 5/160/25 Duplicate Dossier Exforge HCT Approved

Remington Oral Tablet Form 5 Novartis US
Pharma Each film coated tablet 02-02-2011 FDA
Lahore contains: Rs:8,000/- Valam-H
1772 Amlodipine (as 30.07.2013 5/160/25by M/s.
Besylate) B.P…..5mg Rs 12,000/- CCL Pharma
Valsartan Leader Price
U.S.P…..160mg
Hydrochlorothazide
U.S.P…..25mg
(Calcium Channel
Blocker, Angiotensin-II
Receptor Antagonist &
Thiazide Diuretic )
Manufacturer’s
Specification

444. M/s Valpin 10/80 Duplicate Dossier Applied Applied Deferred for
Remington Oral Tablet Form 5 formulation is formulation is confirmation
Pharma Each film coated tablet 02-02-2011 not available in not available in of approval
Lahore contains: Rs:8,000/- reference reference SRA’s. status by
1777 Amlodipine (as 30.07.2013 SRA’s. The firm also
reference
Besylate) B.P…..10mg Rs 12,000/- Valam fails to provide
Valsartan Leader Price 10/80 by M/s. the same.
regulatory
U.S.P…..80mg CCL Pharma authorities
(Calcium Channel
Blocker, Angiotensin-
UII Receptor Antagonist
& Thiazide Diuretic )
Manufacturer’s
Specification

Lahore contains: Rs:8,000/-
1773 Amlodipine (as 30.07.2013 Valam-H
Besylate) B.P…..10mg Rs 12,000/- 10/160/25by
Valsartan Leader Price M/s. CCL
U.S.P…..160mg Pharma
Hydrochlorothazide
U.S.P…..25mg
(Calcium Channel
Manufacturer’s
Specification

Lahore contains: Rs:8,000/-
1774 Amlodipine (as 30.07.2013 Valam-H
Besylate) B.P…..10mg Rs 12,000/- 10/320/25by
Valsartan Leader Price M/s. CCL
U.S.P…..320mg Pharma
Hydrochlorothazide
U.S.P…..25mg
(Calcium Channel
Manufacturer’s
Specification
Following products of M/s. Friends Pharma (Pvt.) ltd were deferred in 257 th meeting of Drug registration board for
approval status of same formulation in reference regulatory authorities and for finished product specification. Now
the firm has submitted the evidence of same formulation in reference regulatory authorities and for finished product
specification. Submitted for consideration of Board.

S/N Name Brand Name Type of Form Remarks on the Remarks by Decision
and (Proprietary name + Initial date, formulation (if Evaluator
address Dosage Form + diary any) including
of Strength) Fee including International
manufact Composition differential fee status in
urer / Pharmacological Demanded stringent drug
Applican Group Price / Pack regulatory
t Finished product size agencies /
Specification authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by
the Evaluator
447. M/s. Ferifend Form-5 International International Deferred
Friends Injection Dy. No: 547 availability is not availability is not for
Pharma Each ml contains: dated. 28-05- confirmed confirmed confirmatio
(Pvt) Piroxicam……….20mg 2011 Rs.8000/- pcam By n of
Limited, Rs.12,000/- M/sMerck
approval
31Km (Analgesic) As per SRO Laboratories.
Ferozpure status by
Road, reference
Lahore regulatory
1095 authorities
448. M/s. Nootrofil Injection Form-5 Dy. No: Availability in Piracetam is a Deferred
Friends Injection 553 dated. 28- SRA is not cyclic derivative for
Pharma Each ml contains: 05-2011 confirmed of GABA. In the confirmatio
(Pvt) Piracetam……..200mg Rs.8000/- United States, it is n of
Limited, Rs.12,000/- As not approved by approval
31Km (Nootropic Drug) per the US Food and
Ferozpure SRO/200mg/ml Nootropil status by
Drug reference
Road, injection by Administration for
Lahore Glaxosmithkline, regulatory
any medical use and authorities
1089 Pakistan 1G/ 5ml
it is not permitted to
be sold as a dietary
supplement. In the
UK, piracetam is
prescribed mainly
for myoclonus, but
is used off-label for
other conditions.
Evidence to support
its use for many
conditions is
unclear.

DDC PEC-II Muhammad Amin.
Sofosbuvir Cases.
S/N Name and Brand Name Type of Form Remarks on Remarks by Decision
address of (Proprietary name + Dosage Initial date, diary the Evaluator
manufacturer / Form + Strength) Fee including formulation (if
Applicant Composition differential fee any) including
Pharmacological Group Demanded Price / International
Finished product Pack size status in
Specification stringent drug
regulatory
agencies /
authorities
Me-too status
GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
449. M/s NovaMed Ledinil Tablet Form 5-D Harvoni, FDA.  Stability Deferred for
Pharmaceuticals Tablet Dairy No. 1928 studies not rectification
(Pvt) Ltd, Each tablet contains:- dated 20-04-2014 Harvoni, of mentioned
Lahore. Sofosbuvir……400mg Rs.50,000/- Ferozsons, submitted. deficiencies
Ledipasvir……90mg 14’s, 28’s Pakistan.  Last and
(Manufacturer’s Specs) Rs.630,000/- Inspection submission of
Rs.11,97,000/- report stability data
required. \
 Undertaking
as per new
format.
450. M/s Barrett Hepgard Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Hodgson Tablet Dairy No. 5335 studies not rectification
Pakistan (Pvt) Each film coated tablet dated 21-08-2015 Harvoni, of mentioned
Ltd. Karachi. contains:- Rs.50,000/- Ferozsons, submitted. deficiencies
Sofosbuvir……400mg 7’s,10’s,14’s,20’s, Pakistan.  Last and
Ledipasvir……90mg 28’s,30’s Inspection submission of
(Direct-acting antiviral agent Rs.24,500/- report stability data
against the hepatitis C virus) Rs.35,000/-
(Mnf Specs) Rs.49,000/-
required.
Rs.70,000/-  Undertaking
Rs.1,05,000/- as per new
format

451. M/s Barrett Hepgard Form 5 Sovaldi, USA.  Stability Deferred for
Hodgson Tablet Dairy No. 5336 studies not rectification
Pakistan (Pvt) Each film coated tablet dated 24-08-2015 Sovaldi, of mentioned
Ltd. Karachi. contains:- Rs.20,000/- Ferozsons, submitted. deficiencies
Sofosbuvir……400mg 7’s,10’s,14’s,20’s, Pakistan  Last and
(Direct-acting antiviral agent 28’s,30’s Inspection submission of
against the hepatitis C virus) Rs.17,500/- report stability data
(Mfg Specs) Rs.25,000/-
Rs.35,000/-
required.
Rs.50,000/-  Undertaking
Rs.70,000/- as per new
Rs.75,000/- format
452. M/s Indus Indovir 400mg Form 5-D Sovaldi, USA.  Stability Deferred for
Pharma (Pvt.) Tablet Dairy No. 264 studies not rectification
Ltd., Each film coated tablet dated 17-09-2014 Sovaldi, of mentioned
contains:- Rs.20,000/- Ferozsons, submitted. deficiencies
Sofosbuvir……400mg As per SRO] Pakistan  Last and
(Anti-Viral) As per SRO Inspection submission of
report stability data
required.
 Undertaking
as per new
format not
submitted.
453. M/s Nawan Virosof Form 5 Sovaldi, USA.  Stability Deferred for
Laboratories Pvt Tablet Dairy No. 402 rectification
Ltd. Karachi. Each film coated tablet dated 22-03-2016 Sovaldi, studies not of mentioned
Sofosbuvir……400mg As per SRO Pakistan and
(Antihepatitis ATC Code: As per SRO  Last submission of
JO5AB) stability data
(Manufacturer’s Specs) Inspection
report
required.
 Undertaking
as per new
format not
submitted.
454. M/s Helix Sofoled 90mg/400mg Form 5-D Harvoni, FDA.  Stability Deferred for
Pharma (Pvt) Tablet Dairy No. 512 rectification
Ltd Karachi. Each film coated tablet dated 11-04-2016 Harvoni, studies not of mentioned
Ledipasvir……90mg As per SRO Pakistan. and
Sofosbuvir……400mg As per SRO  Undertaking submission of
(Direct Acting Antiviral) stability data
as per new
format

455. M/s Paramount Savior Form 5 Sovaldi, USA.  Stability Deferred for
Pharmaceutical Tablet Dairy No. 1201 rectification
Islamabad. Each tablet contains:- dated 09-10-2015 Sovaldi, studies not of mentioned
Sofosbuvir……400mg Rs.20,000/- Ferozsons, submitted. deficiencies
(Anti-infective, Antiviral) As per SRO Pakistan and
 Last submission of
stability data
Inspection
report
required.
 Undertaking
as per new
format
456. M/s Rotex Sonata Form 5 Harvoni, FDA.  Stability Deferred for
Pharma Tablet Dairy No. 78 rectification
Islamabad. Each film coated tablet dated 11-01-2016 Harvoni, studies not of mentioned
Ledipasvir…….90mg 28’s Pakistan. and
(Nucleotide Analog NSB stability data
Polymerase Inhibitor & as per new
Nucleotide NS5B Inhibitor Anti format.
viral)
 Inspection
report states
that firm has
limited
capacity of
production.
457. M/s Pharmix Alvir Form 5-D Harvoni, FDA.  Stability Deferred for
Laboratories Pvt Tablet Dairy No.1452 studies not rectification
Ltd, Lahore Each film coated tablet dated 13-11-2015 Harvoni, submitted. of mentioned
contains:- Rs.50,000/- Ferozsons, deficiencies
 Last Inspection
Sofosbuvir……400mg Rs.100,000/- submission of
(Antiviral Agent) report stability data
required.
 Undertaking as
per new format
458. M/s Nexus Sofonex Form 5-D Sovaldi, USA.  Stability Deferred for
Pharma Karachi. Tablet Dairy No.2299 rectification
Each film coated tablet dated 25-11-2015 Sovaldi, studies not of mentioned
Sofosbuvir……400mg As per SRO Pakistan and
(Hepatitis C virus (HCV)  Last submission of
Nucleotide analog stability data
Inspection

report
required.
 Undertaking
as per new
format
459. M/s Bosch Lesovir Form 5 Sovaldi, USA.  Stability Deferred for
Pharmaceutical Tablet Dairy No.87 rectification
Karachi. Each film coated tablet dated 20-01-2016 Sovaldi, studies not of mentioned
Ledipasvir……90mg 28’s Pakistan and
(Hepatitis C virus (HCV) stability data
nucleotide analog NSB as per new
polymerase inhibitor) format not
submitted.
460. M/s Siam Sifos Plus Form 5-D Sovaldi, USA.  Stability Deferred for
Pharmaceuticals Tablet Dairy No.1272 rectification
Islamabad. Each film coated tablet dated 03-03-2016 Sovaldi, studies not of mentioned
Ledipasvir……90mg As per SRO Pakistan and
Sofosbuvir……400mg  Last submission of
(Antiviral) stability data
Inspection
report
required..
 Undertaking
as per new
format not
submitted.
461. M/s Crystolite Hepled Form 5-D Harvoni, FDA.  Stability Deferred for
Pharmaceuticals, Tablet Dairy No.3099 rectification
Islamabad. Each film coated tablet dated 30-12-2015 Harvoni, studies not of mentioned
Ledipasvir……90mg As per SRO Pakistan. and
Sofosbuvir……400mg submission of
(Antiviral against Hepaptis C) stability data
(Manufacturer’s Specs)

462. M/s Medisave Sobovir Form 5 Sovaldi, USA.  Stability Deferred for
Pharmaceuticals Tablet Dairy No.1092 studies not rectification
Lahore. Each film coated tablet dated 12-10-2015 Sovaldi, of mentioned
Sofosbuvir……400mg As per SRO Pakistan  Last and
(Antivirals for systemic use) Inspection submission of
report stability data
required.
 Undertaking
as per new
format not
submitted.
463. M/s Global Cure-C Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Pharmaceutical Tablet Dairy No.1035 studies not rectification
Pvt. Ltd Each film coated tablet dated 18-02-2016 Harvoni, of mentioned
Islamabad. contains:- Rs.50,000/- Ferozsons, submitted. deficiencies
Sofosbuvir……400mg As per SRO Pakistan.  Undertaking and
Ledipasvir…..90mg as per new submission of
(Anti-viral agent) format not stability data
Manufacturer’s Specs
submitted.
464. M/s Jenner Sobovir Form 5 Sovaldi, USA.  Stability Deferred for
Pharmaceuticals Tablet Dairy No.1205 rectification
Pvt. Ltd. Each film coated tablet dated 20-10-2015 Sovaldi, studies not of mentioned
Sofosbuvir……400mg 28’s Pakistan and
(Direct-acting antiviral) As per SRO submission of
Manufacturer’s Specs stability data
465. M/s Martin Dow Osvir Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Karachi. Film coated Tablet Dairy No.795 rectification
Each film coated tablet dated 04-11-2015 Harvoni, studies not of mentioned
Sofosbuvir……400mg 7’s,14’s,28’s Pakistan. and
Ledipasvir…….90mg Rs.21,000/-  Undertaking submission of
(Antiviral) Rs.42,000/- stability data
Manufacturer’s Specs Rs.84,000/- as per new
format not
submitted.
466. M/s Wilshire Ziqar Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Laboratories Tablet Dairy No.795 studies not rectification
(Pvt) Ltd. Each film coated tablet dated 04-11-2015 Harvoni, submitted. of mentioned
Lahore. contains:- Rs.50,000/- Ferozsons, deficiencies
Sofosbuvir……400mg 1’s,5’s,10’s,30’s, Pakistan. and
 Last Inspection
Ledipasvir…….90mg 50’s submission of
(Antiviral) As per SRO report stability data
required.
 Undertaking as

per new format
467. M/s Saffron Viraldi Form 5-D Harvoni, FDA.  Stability Deferred for
Pharmaceutical Tablet Dairy No.185 rectification
Faisalabad. Each tablet contains:- dated 07-12-2015 Harvoni, studies not of mentioned
Sofosbuvir……400mg Rs.50,000/- Ferozsons, submitted. deficiencies
(HCV NS5A Inhibitor and Rs.60,000/- submission of
Nucleotide analog inhibitor of stability data
Hcv NS5B Polymerase.)
468. M/s Seatle Pvt Isuvir Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Limited, Lahore. Tablet Dairy No.1361 rectification
Each film coated tablet dated 04-11-2015 Harvoni, studies not of mentioned
Sofosbuvir……400mg 7’s,14’s,28’s Pakistan. and
Ledipasvir…….90mg Rs.21,000/-  Undertaking submission of
(Antiviral.) Rs.42,000/- stability data
Rs.84,000/- as per new
format not
submitted.
469. M/s OBS Viratron-Plus Form 5-D Harvoni, FDA.  Stability Deferred for
Pakistan, Film coated Tablet Dairy No.214 rectification
studies not
Karachi. Each film coated tablet dated 03-06-2015 Harvoni, of mentioned
Sofosbuvir……400mg 28’s Pakistan.  Last and
Ledipasvir…….90mg Rs.364,000/- Inspection submission of
(Antiviral.) report stability data
required.
 Undertaking
as per new
format not
submitted.
470. M/s Hilton Sofoled Form 5-D Harvoni, FDA.  Stability Deferred for
Pharma, Karachi Film coated Tablet Dairy No.273 studies not rectification
Each film coated tablet dated 06-03-2015 Harvoni, of mentioned
contains:- As per DPC Ferozsons, submitted. deficiencies
Sofosbuvir……400mg Rs.364,000/- Pakistan.  Last and
Ledipasvir…….90mg Inspection submission of
(Antiviral.) report stability data
required.

471. M/s Tabros Concerta 400/90 mg Tablets Form 5-D Harvoni, FDA.  Stability Deferred for
Pharma, Karachi Each Film coated tablets Dairy No.273 studies not rectification
contain: dated 06-03-2015 Harvoni, of mentioned
Sofosbuvir….400 mg As per DPC Ferozsons, submitted. deficiencies
Ledipasvir…….90 mg Rs.3392.85 per Pakistan.  Last and
tablet. Inspection submission of
Pack 2 × 14: Rs report stability data
95000/-
required.
 Undertaking
as per new
format not
submitted.
472. M/s Sami, Daclavir 30 mg tablets Form 5-D Deklinza of Stability data of 06 Deferred for
Karachi Each film coated tablet Dy no: 1241 dated: M/s BMS, UK. months accelerated rectification
contains: 14.6.2016 and real time is of mentioned
Daclatasvir (as dihydrochloride) Rs: 50,000 New Molecule required deficiencies
30 mg Price: 6500/ 28 and
Mfg Specs Tablets submission of
stability data
473. M/s Sami, Daclavir 60 mg tablets Form 5-D Deklinza of -do- Deferred for
Karachi Each film coated tablet Dy no: 1240 dated: M/s BMS, UK. rectification
contains: 14.6.2016 of mentioned
Daclatasvir (as dihydrochloride) Rs: 50,000 New Molecule deficiencies
60 mg Price: 13000/ 28 and
Mfg Specs Tablets submission of
stability data
474. M/s Hilton Clavir tablets 30 mg Form 5-D Deklinza of Stability data of 06 Deferred for
Pharma, Karachi Each film coated Tablet : Dy. No. 403 M/s BMS, UK. months accelerated rectification
Daclatasvir …………30mg dated: 14.09.2015 and real time is of mentioned
(equivalent to 33mg daclatasvir Rs: 50,000 New Molecule required deficiencies
dihydrochloride) As Per DPC and
submission of
stability data
475. M/s Hilton Clavir tablets 60 mg Form 5-D Deklinza of -do- Deferred for
Pharma, Karachi Each film coated Tablet : Dy. No 402 M/s BMS, UK. rectification
Daclatasvir dated: 14.09.2015 of mentioned
…………60mg(equivalent to Rs: 50,000 New Molecule deficiencies
66mg daclatasvir As Per DPC and
dihydrochloride) submission of
stability data

Deferred Cases:
Following cases of M/s Selmore Pharmaceutical Lahore were deferred in M-258th due to me too
status now the firm has submitted the deficiencies.
S/N Name and Brand Name Type of Form Remarks on Decision

address of (Proprietary name + Dosage Form Initial date, diary the
manufacturer / + Strength) Fee including formulation
Applicant Composition differential fee (if any)
Pharmacological Group Demanded Price / Pack including
Finished product Specification size International
status in
stringent
drug
regulatory
agencies /
authorities
Me-too status
GMP status
as depicted in
latest
inspection
report (with
date) by the
Evaluator
476. M/s. Selmore Novacin intra-Mammary Suspension Form-5 Me-too not Rejected on
Pharmaceuticals Liquid Injectable Dy. No.138 available the grounds
(Pvt) Limited, Each 5ml contains:- Dated.28-01-2016 that me-too
36 Km, Multan Penicillin G Rs.20,000/- of the drug
Road, Lahore. Sodium…………..200,000IU Decontrolled
is not
Novobiocin Sodium eq. to 10ml,10ml x 12’s
Novobiocin ………………….400mg 10mlx24’s available
(2 years)
477. M/s. Selmore Speclimox Oral Dry Powder Form-5 Me-too not Rejected on
Pharmaceuticals Oral Dry Powder Dy. No.133 available the grounds
(Pvt) Limited, Each Kg powder contains:- Dated.28-01-2016 that me-too
36 Km, Multan Amoxicillin Trihydrate (BP) eq. to Rs.20,000/- of the drug
Road, Lahore. Amoxicillin…………….......200mg Decontrolled
is not
Lincomycin HCI (BP) eq. to 100gm,250gm
Lincomycin…..88mg 500gm,1Kg available
Spectinomycin Sulphate (BP VET).
eq. to Spectinomycin……........88mg
(Board Spectrum Antibiotics
(Penicillin/ Aminoglycosides)
02 years

Grant of Registration to New Drug Manufacturing Licenses
DDC-PEC-I Dr.Hafsa Karam Ellahi
S/N Name and address of Brand Name Type of Form International Remarks Decision
manufacturer / Applicant (Proprietary Initial date, status in
name + Dosage diary reference drug
Form + Fee including agencies /
Strength) differential fee authorities
Composition Demanded Me-too status
Pharmacological Price / Pack GMP status as
Group size depicted in
Finished product latest
Specification inspection
report (with
date) by the
Evaluator
Tablet (General)
478. Scilife Pharma Leflo Tablet 250 mg Form 5 FDA approved Approved
(Private) Each film coated Rs. 20,000/- Tablet Levaquin
Limited tablet contains: Dy. No.1156 250 mg
Plot # FD- Levofloxacin 250 mg 08-06-2016 manufactured by
57/58-A2, (as hemihydrates) 10’s,30’s Janssen Pharms
Korangi Creek (Scilife Spec) As Per SRO
Industrial Quinolone Tablet
park (KCIP) Antibiotics Dynaquin 250
Karachi mg by Barrett
Hodgson
Tablet
(General)
approved in
247st meeting
of Central
Licensing
Board held on
29-04-2016.
479. -do- Leflo Tablet 500 mg Form 5 FDA approved Approved
Each film coated Rs. 20,000/- Tablet Levaquin
tablet contains: Dy. No.1155 500 mg
Levofloxacin 500 mg 08-06-2016 manufactured by
(as hemihydrates) 10’s,30’s Janssen Pharms
(Scilife Spec) As Per SRO
Quinolone Tablet
Antibiotics Dynaquin 500
mg by Barrett
Hodgson
480. -do- Leflo Tablet 750 mg Form 5 FDA approved Approved

Each film coated Rs. 20,000/- Tablet Levaquin
tablet contains: Dy. No. 1154 750 mg
Levofloxacin 750 mg 08-06-2016 manufactured by
(as hemihydrates) 10’s,30’s Janssen Pharms
(Scilife Spec) As Per SRO
Quinolone Leflox by M/s
Antibiotics Getz Pharma

481. -do- Amstan Tablet 5/80 Form 5 FDA approved Approved
mg Dy. No. 1206 Tablet
Each film coated Dated.08-06-2016 Exforge 5/80 mg
tablet contains: Rs. 20,000/- manufactured by
Amlodipine: 5 mg (as Pack of 14’s,28’s /as Novartis
Amlodipine Besylate) per SRO
Valsartan: 80 mg Tablet
(Scilife Spec) Avsar 5/80 mg
Anti-Hypertensive manufactured by
Pharmevo
482. -do- Amstan Tablet 5/160 Form 5 FDA approved Approved

mg Rs. 20,000/- Tablet
Each film coated Dy. No.1207 Exforge 5/160
tablet contains: Dated.08-06-2016 mg
Amlodipine: 5 mg (as 14’s,28’s manufactured by
Amlodipine Besylate) As Per SRO Novartis
Valsartan: 160 mg
(Scilife Spec) Tablet
Anti-Hypertensive Avsar 5/160 mg
manufactured by
Pharmevo
483. -do- Amstan Tablet Form 5 FDA approved Approved

10/160 mg Rs. 20,000/- Tablet
Each film coated Dy. No.1208 Exforge 10/160
tablet contains: Dated.08-06-2016 mg
Amlodipine: 10 mg 14’s,28’s manufactured by
(as Amlodipine As Per SRO Novartis
Besylate)
Valsartan: 160 mg Tablet
(Scilife Spec) Avsar 10/160
Anti-Hypertensive mg
manufactured by
Pharmevo
484. -do- Co-Amstan Tablet Form 5 FDA approved Approved

5/160/12.5 mg Rs. 20,000/- Tablet
Each film coated Dy. No. 1209 Exforge HCT
tablet contains: 08-06-2016 5/160/12.5 mg
Valsartan: 160 mg
Hydrochlorothiazide Tri-Valsan by
USP: 12.5 mg M/s Hilton
(Scilife Spec) Pharma
Anti-Hypertensive
10/160/12.5 mg Rs. 20,000/- Tablet
Each film coated Dy. No.1173 Exforge HCT
tablet contains: 08-06-2016 10/160/12.5 mg
Besylate)
Valsartan: 160 mg Tri-valsan by
Hydrochlorothiazide Hilton Pharma

USP: 12.5 mg
(Scilife Spec)
Anti-Hypertensive
5/160/25 mg Rs. 20,000/- Tablet
tablet contains: 08-06-2016 5/160/25 mg
Valsartan: 160 mg
Hydrochlorothiazide Tri-Valsan by
USP: 25 mg M/s Hilton
(Scilife Spec) Pharma
Anti-Hypertensive
10/160/25 mg Rs. 20,000/- Tablet
tablet contains: 08-06-2016 10/160/25 mg
(as Amlodipine Novartis
Besylate)
Valsartan: 160 mg Tri-Valsan by
Hydrochlorothiazide M/s Hilton
USP: 25 mg Pharma
(Scilife Spec)
Anti-Hypertensive
10/320/25 mg Rs. 20,000/- Tablet
Each film coated Dy. No.1157 Exforge HCT
tablet contains: 08-06-2016) 10/320/25 mg
Besylate)
Valsartan: 320 mg Tri-Valsan by
Hydrochlorothiazide M/s Hilton
USP: 25 mg Pharma
(Scilife Spec)
Anti-Hypertensive
489. -do- Cowaldi Tablet 400 Form 5 FDA approved Stability Deferred
mg Rs. 20,000/- Tablet Sovaldi data is for
Each film coated Dy. No. 1186 400 mg required.
tablet contains: 08-06-2016 manufactured by
submissio
Sofosbuvir 400 mg 30’s As Per SRO Gilead science n of
(Scilife Spec) stability
Anti-Hepatitis C Tablet Sofos data as per
400 mg by guidelines
Genix Pharma
approved
by
registratio
n Board in
251st
meeting

490. -do- Arixa Tablet 10 mg Form 5 FDA approved Approved
Each film coated Rs. 20,000/- Tablet Xarelto
Rivaroxaban 10 mg 08-06-2016 manufactured by
(Scilife Spec) 14’s,28’s Janssen Pharms
Anti-Coagulant As Per SRO
Tablet
Xarelto 10 mg
manufactured by
Bayer

Anti-Coagulant As Per SRO
Tablet
Xarelto 15 mg
manufactured by
Bayer

Anti-Coagulant
Tablet
Xarelto 20 mg
manufactured by
Bayer
493. -do- Wilda-M Tablet Form 5 TGA & EMA Approved
50/500 mg Rs. 20,000/- approved Tablet
Each film coated Dy. No.1192 Eucreas 50/500
tablet contains: 08-06-2016 mg
Vildagliptin 14’s,28’s manufactured by
50 mg As Per SRO Novartis
Metformin HCl 500
mg Tablet
(Scilife Spec) Galvus Met
Anti-Diabetic 50/500 mg
manufactured by
Novartis

Vildagliptin manufactured by
50 mg 14’s,28’s Novartis
Metformin HCl 850 As Per SRO Tablet
mg Galvus Met
(Scilife Spec) 50/850 mg
Anti-Diabetic manufactured by
Novartis

Vildagliptin Pack of 14’s/as per manufactured by
50 mg DPC Novartis
Metformin HCl 1000 28’s / as per DPC
mg Tablet
(Scilife Spec) Galvus Met
Anti-Diabetic 50/1000 mg
manufactured by
Novartis
496. -do- Dolobid-P Tablet Form 5 FDA approved Approved

325/37.5 mg Rs. 20,000/- Tablet Ultracet with
Each film coated Dy. No.1190/- 325/37.5 mg
change of
Paracetamol 10’s,30’s Janssen Pharm brand
325 mg As Per SRO name
Tramadol HCL 37.5
mg Tablet
(Scilife Spec) Tramal Plus
Analgesic 325/37.5 mg
manufactured by
Searle Pharma
497. -do- Omitax Tablet 10/10 Form 5 FDA approved Approved

mg Rs. 20,000/- Tablet Diclegis
Each enteric coated Dy. No. 1185 10/10 mg
tablet contains 08-06-2016 manufactured by
Doxylamine 10’s,30’s Duche Snay
Succinate 10 mg
Pyridoxine Tablet
Hydrochloride 10 mg Envepe 10/10
(Scilife Spec) mg
Anti-emetic manufactured by
RG Pharma
498. -do- Romilast Tablet 500 Form 5-D FDA approved Stability Deferred
mcg Rs. 50,000/- Tablet data is for
Each tablet contains: Dy. No. Daliresp 500 required.
Roflumilast 08-06-2016 mcg
submissio
500 mcg 10’s,20’s,30’s manufactured by n of
(Scilife Spec) As Per SRO Astrazeneca stability
Phosphodiesterase Pharms data as per
Inhibitor guidelines
approved
by
registratio
n Board in
251st
meeting

499. -do- Scimox Tablet 400 Form 5 FDA approved Approved
mg Rs. 20,000/- Tablet Avelox
Each Film coated Dy. No. 1191 400 mg
Moxifloxacin…400 5’s/ As Per SRO Bayer Health
mg (as care
Hydrochloride)
(Scilife Spec) Tablet
Quinolones Moxiget 400
Antibiotic mg
manufactured by
Getz Pharma
Capsule (General)
500. Scilife Pharma Dolobid Capsule Form 5 TGA Approved Approved
(Private) Limited 50mg Rs. 20,000/- Zydol by M/s with
Plot # FD-57/58-A2, Dy. No.1183 Arrow Pharma
Korangi Creek Each capsule 08-06-2016
change of
Industrial park (KCIP) contains 10’s,30’s Tamadol 50 mg brand
Karachi Tramadol HCl 50mg As Per SRO (Highnoon name
Pharma)
Capsule (General) Analgesic (Scilife
approved in 247st Spec)
meeting of Central
Licensing Board held
on 29-04-2016.
501. -do- Duloxa Capsule Form 5 FDA approved Approved
20mg Rs. 20,000/- capsule
Each capsule Dy. No.1182 Cymbalta 20 mg
contains 08-06-2016 manufactured by
Duloxetine HCL 14’s,28’s Lilly
17.65% enteric
coated pellets Dulan 20 mg
equivalent to 20 mg (Hilton Pharma)
Duloxetine
Serotonin/Nor
epinephrine Re-
uptake Inhibitor
(Scilife Spec)
Source of pellets
M/s Surge
laboratories Private
Limited,
Sheikhupura
Duloxetine HCL Lilly
17.65% enteric 14’s,28’s
coated pellets As Per SRO Dulan 30 mg
equivalent to 30 mg (Hilton Pharma)
Duloxetine
Serotonin/Nor
epinephrine Re-

uptake Inhibitor
(Scilife Spec)
Source of pellets
M/s Surge
Limited,
Sheikhupura
Duloxetine HCL 14’s, 28’s As Lilly
17.65% enteric Per SRO Dulan 60 mg
coated pellets (Hilton Pharma)
equivalent to 60 mg
Duloxetine
Serotonin/Nor
epinephrine Re-
uptake Inhibitor
(Scilife Spec)
Source of pellets
M/s Surge
Limited,
Sheikhupura
504. -do- Timsol Capsule 0.4 Form 5 FDA approved Approved
mg Rs. 20,000/- capsule Flomax
Dy. No.1178 0.4 mg
Each capsule 08-06-2016 manufactured by
contains 20’s,30’s Boehringer
Tamsulosin HCl As Per SRO Ingelheim
0.2% Pellets
equivalent to 0.4 mg Tamsolin 0.4 mg
Tamsulosin (Getz Pharma)
Peripherally acting
anti-adrenergic
(Scilife Spec)
Source of pellets
M/s Vision
Pharmaceuticals,
Islamabad
505. -do- Ozon Capsule 20 Form 5 FDA approved Approved
mg Rs. 20,000/- capsule Prilosec
Each capsule Rs.80000/- Dy. 20 mg
contains No.1177 08- manufactured by
Omeprazole 12.5% 06-2016 Astrazeneca
Enteric coated Pharma
Pellets equivalent to 14’s,28’s
20 mg Omeprazole Risek 20 mg
(Getz Pharma)
Proton Pump
Inhibitor
(Scilife Spec)

Source of pellets
M/s Spansules
Formulation, India
506. -do- Ozon Capsule 40 Form 5 FDA approved Approved

mg Rs. 20,000/- capsule Prilosec
Rs.80000/- Dy. 40 mg
Each capsule No.1176 08- manufactured by
contains 06-2016 Astrazeneca
Omeprazole 12.5% Pharma
Enteric coated Pack of
Pellets equivalent to 14’s / as per Risek 40 mg
40 mg Omeprazole DPC (Getz Pharma)
28’s / as per
Proton Pump DPC
Inhibitor
(Scilife Spec)
Source of pellets
M/s Spansules
Formulation, India
507. -do- Mebrin MR Capsule Form 5 MHRA Approved
200 mg Rs. 20,000/- approved
Rs.80,000/- capsule Colofac
Each capsule Dy. No.1179 MR
Mebeverine HCl 10’s,20’s As Abbott
MR 80% Pellets 200 Per SRO
mg Mebever MR
200 mg
Anti-Spasmodic (Getz Pharma)
(Scilife Spec)
Source of pellets
M/s Spansules
Formulation, India
508. -do- Dexlanz Capsule 30 Form 5 USFDA Me too Deferred
mg Rs. 20,000/- approved needs to for
Rs.80,000 capsule
Each gastro resistant Dy. No.1205 Dexilant 30 mg
be submissio
Capsule contains: 08-06-2016 manufactured by verified. n of
Dexlansoprazole 14’s / As Per Takeda Pharma applicatio
22.5% Enteric SRO n on Form
Coated Pellets…… 5D,
30 mg
requisite
Proton pump fee and
Inhibitor stability
(Scilife Spec) data as per
guidelines
Source of pellets
M/s Spansules
approved
Formulation, India by
registratio

n Board in
251st
meeting
509. -do- Dexlanz Capsule 60 Form 5 USFDA Me too Deferred
mg Rs. 20,000/- approved needs to for
Each gastro resistant Rs.80,000/-Dy. capsule
Capsule contains: No.1204 Dexilant 60 mg
be submissio
Dexlansoprazole 08-06-2016 manufactured by verified. n of
22.5% Enteric 14’s As Per Takeda Pharma Invalid applicatio
Coated Pellets….60 SRO GMP n on Form
mg Me too needs to certificat 5D,
Proton pump be verified.
Inhibitor
e requisite
(Scilife Spec) attached. fee and
Source of pellets stability
M/s Spansules data as per
Formulation, India guidelines
approved
by
registratio
n Board in
251st
meeting
Sachet (General)
510. Scilife Pharma (Private) Asthiven 4mg Form 5 FDA Approved Approved
Limited Sachet Rs. 20,000/- Singular
Plot # FD-57/58-A2, Each Sachet Dy. No.1203 Merck (FDA)
Korangi Creek contains 08-06-2016 Solo Powder 4
Industrial park (KCIP) Montelukast 14’s,28’s mg
Karachi Sodium eq. to As Per SRO manufactured by
Montelukast 4 mg (Atco)
Sachet (General) Leukotriene
approved in 247st receptor antagonist
meeting of Central (Scilife Spec)
Licensing Board held
on 29-04-2016.
511. -do- Ozon Insta Powder Form 5 FDA Approved In Deferred
20 mg Sachet Rs. 20,000/- Zegerid review in as
Dy. No.1196 Santarus INC
Each Sachet 08-06-2016
250th formulatio
contains 10’s,30’s Risek Insta meeting n is under
Omeprazole As Per SRO Powder 20 mg
20 mg manufactured by
Sodium (Getz Pharma)
Bicarbonate 1680
mg (as buffer)
Proton Pump
Inhibitor
(Scilife Spec)
512. -do- Ozon Insta Powder Form 5 FDA Approved Internati Deferred
40 mg Sachet Rs. 20,000/- Zegerid onal as

Each Sachet Dy. No.1195 Santarus INC availabili formulatio
contains 03-06-2016 Risek Insta ty n is under.
Omeprazole 10’s,30’s Powder 40 mg
40 mg As Per SRO manufactured by
discontin Also
Sodium (Getz Pharma) ue from confirmati
Bicarbonate 1680 market. on
mg (as buffer) In regarding
Proton Pump review in approval
Inhibitor
(Scilife Spec)
250th status by
meeting reference
regulatory
authorities
513. -do- Forlax Sachet Form 5 TGA & MHRA Approved
Each Sachet Rs. 20,000/- Approved
contains Dy. No.1201 Movicol Sachet
PEG 3350 08-06-2016
Norgine Limited
…..13.125 g
Sodium Chloride…. 10’s,20’s
Movcol
0.3507 g As Per SRO
manufactured by
Sodium
(Genix Pharma)
bicarbonate….
0.1785 g
Potassium
chloride…
0.0466 g
Somatically acting
laxatives (Scilife
Spec)
514. -do- Forlax Junior Form 5 TGA & MHRA Composi Deferred
Sachet Rs. 20,000/- Approved tion API for
Each Sachet Dy. No.1200 Movicol Junior
contains 08-06-2016) Sachet
in me confirmati
PEG 3350 too is on of
Norgine Limited different
…..6.563 g 10’s,20’s compositi
Sodium Chloride…. As Per SRO from the on as per
Movcol
0.1754 g
manufactured by product me too
Sodium
bicarbonate….
(Genix Pharma) applied
0.0893 g for
Potassium
chloride… Sodium
0.0251 g Chloride…
.
Somatically acting 350.7mg
laxatives (Scilife Sodium
Spec) bicarbonat
e….
178.5mg
Potassium
chloride…
46.6mg

515. -do- Hydro Sachet Form 5 Non- Composi Approved
Each Sachet Rs. 20,000/- Proprietary Oral tion API
contains Dy. No.1199 Rehydration
Anhydrous Glucose 08-06-2016 Salt BP
in me
13.50 g too is
WHO
Tri sodium citrate 20’s,30’s As different
Recommended
Dihydrate 2.90 g Per SRO from the
Formulation
Sodium Chloride product
2.60 g Cellchem
Potassium Chloride Pharmaceutical
applied
1.50 g Incorporation, for
Canada
Electrolyte Solution Anhydrous
(Anti-diarrheal) Peditral Sachet Glucose 20
by M/s Searl g
(Scilife Spec) Pharma sodium
citrate
2.90g
Sodium
Chloride
3.5g
516. -do- One soda Sachet Form 5 TGA Approved Composi Deferred
Rs. 20,000/- Ural sachet tion of for
Each Sachet Dy. No.1197 Aspen Pharma
contains 08-06-2016
API in confirmati
Sodium Bicarbonate 20’s Citro soda ural on of
1.716 g As Per SRO manufactured by sachet is compositi
Sodium citrate (Abbott) different on as per
0.613g from the me too
Citric acid
0.702 g
product
Tartaric acid 0.858 applied
g for
Urinary and gastric Sodium
alkaliniser Bicarbonat
(Scilife Spec) e 1.76 g
Sodium
citrate
0.63g
Citric acid
0.72 g
Tartaric
acid 0.89 g
517. -do- Mehvisk Sachet Form 5 MHRA Approved Approved

Rs. 20,000/- Dy. Fybogel
Each Sachet contains No.1198 08-06- Mebeverine
Mebeverine HCl 135 2016 Forum Health
mg 10’s,20’s Product Limited
Isaphagul husk 3.5 g As Per SRO
Musk-MSachet
Antispasmodic, Anti manufactured by
Constipative Genix Pharma )
(Scilife Spec)

Evaluator-I Muhammad Ansar
Additional Sections.
Additional section Veterinary
S/N Name and Brand Name Type of Form Remarks on the Remarks by Decision
address of (Proprietary name + formulation (if Evaluator/
manufacturer Dosage Form + Strength) Initial date, diary any) including Decision
/ Applicant International
Composition Fee including status in
differential fee stringent drug
Pharmacological Group regulatory
Demanded Price / Pack agencies /
Finished product size authorities
Specification
Me-too status
GMP status as
depicted in
latest inspection
report (with
date) by the
Evaluator
518. M/s Sanna ATC-Forte Oral water Form 5 Approved
Laboratories, Soluble Powder
1019-B, PSIE, Dy No.442 dated 20-05- Local. Amox-C
Sargodha Each 100gm contains:- 2016 Rs.20,000. Maarson by
Road, Amoxicillin Decontrolled/100gm, Attabak.
Faisalabad. Trihydrate……50gm 300gm, 500gm, 1kg,
Colistin 5kg, 10kg & 25kg.
Sulphate…….50MIU
Antibacterial
Manufacturer’s
Specifications
519. -do- Himox-50 Oral water Form 5 Approved
Soluble Powder
Dy No.446 dated 20-05- Local. Amoxi-50
Each 1000gm contains:- 2016 Rs.20,000. by M/s Symans.
Amoxicillin Trihydrate eq
to Amoxicillin……500gm Decontrolled/100gm,
300gm, 500gm, 1kg,
Antibacterial 5kg, 10kg & 25kg.
520. -do- Lincosac-200 Oral water Form 5 Approved

Soluble Powder
Dy No.440 dated 20-05- Local. Amoxy
Each 1000gm contains:- 2016 Rs.20,000. L.S by M/s
Amoxicillin Trihydrate Inshall.
……20gm Decontrolled/100gm,
Lincomycin 300gm, 500gm, 1kg,
HCl……….8.8gm 5kg, 10kg & 25kg.

Spectinomycin
2HCl…….8.8gm
Antibacterial
Manufacturer’s
Specifications
521. -do- Clavmox-Forte Oral water Form 5 Approved
Soluble Powder
Dy No.445 dated 20-05- Local. Wealmox-
Each 100gm contains:- 2016 Rs.20,000. Plus by M/s Prix.
Amoxicillin as Amoxicillin
Trihydrate ……16gm Decontrolled/100gm,
Clavulanic Acid as 300gm, 500gm, 1kg,
Potassium 5kg, 10kg & 25kg.
Clavulanate……4gm
Bromhexine
HCl…………….0.5gm
Antibacterial
Manufacturer’s
Specifications
522. -do- Clavmox-200 Oral water Form 5 Approved
Soluble Powder
Dy No.441 dated 20-05- Local. Primox-
Each 100gm contains:- 2016 Rs.20,000. Plus by M/s Prix.
Amoxicillin as Amoxicillin
Trihydrate ……16gm Decontrolled/100gm,
Clavulanic Acid as 300gm, 500gm, 1kg,
Potassium 5kg, 10kg & 25kg.
Clavulanate……4gm
Antibacterial
523. -do- Himox-70 Oral water Form 5 Approved

Soluble Powder
Dy No.443 dated 20-05- Local. Primox
Each 100gm contains:- 2016 Rs.20,000. 70% by M/s Prix.
Amoxicillin Trihydrate
80gm eq to Amoxicillin Decontrolled/100gm,
……70gm 300gm, 500gm, 1kg,
5kg, 10kg & 25kg.
Antibacterial
524. -do- GP-80 Oral water Soluble Form 5 Approved

Powder
Dy No.444 dated 20-05- Local. PSB-100
Each 1000gm contains:- 2016 Rs.20,000. by M/s Epla.
Zinc Bacitracin ……52gm
Procaine Penicillin Decontrolled/100gm,
……..12gm 300gm, 500gm, 1kg,
Streptomycin 5kg, 10kg & 25kg.
Sulphate……36gm
Antibacterial

M/s Vision Pharma Human Additional section
S/N Name and Brand Name Type of Form Remarks on the Remarks by Decision
address of (Proprietary name + Dosage formulation (if Evaluator/
manufacturer / Form + Strength) Initial date, any) including Decision
Applicant diary International
Composition status in stringent
Fee including drug regulatory
Pharmacological Group differential agencies /
fee authorities
Finished product Specification
Demanded Me-too status
Price / Pack
size GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator
525. M/s Vision Linzy 600mg Infusion Form 5 MHRA. Linzolid Approved
Pharmaceuticals, 2mg/ml by M/s
Plot No. 22 & Each vial of 300ml contains:- Dy No. 2713 Pfizer
23, Industrial Linezolid……….…..600mg dated 16-06-
Triangle Kahuta 2016 Local. Lezol
Road, Antibiotic Rs.20,000. 600mg by M/s
Islamabad. Bosch.
“Liquid Vial Manufacturer’s Specifications As per
General SRO/1’s
approved in
247th meeting of
CLB.”
526. -do- Linzy 400mg Infusion Form 5 MHRA. Linzolid Approved
2mg/ml by M/s
Each vial of 200ml contains:- Dy No. 2715 Pfizer
Linezolid……….…..400mg dated 16-06-
2016 Local. Lezol
Antibiotic Rs.20,000. 400mg by M/s
Bosch.
Manufacturer’s Specifications As per
SRO/1’s
527. -do- Linzy 200mg Infusion Form 5 MHRA. Linzolid Approved
2mg/ml by M/s
Linzolid……….…..200mg dated 16-06-
2016 Local. Zolrest
Antibiotic Rs.20,000. 200mg by M/s
Bosch.
SRO/1’s
528. -do- Katafast 500mg Injection Form 5 MHRA. Ketalar Approved
50mg/ml by M/s
Ketamine hydrochloride equivalent dated 16-06-
to ketamine……….…..500mg 2016 Local. Ketarol
Rs.20,000. 500mg by M/s
Anesthetic Global

As per Pharmaceuticals
USP Specifications SRO/1’s
529. -do- Odimox 400mg Infusion Form 5 MHRA. Avelox by Approval status Advised to
M/s Bayer in reference apply Form 5
Each vial of 100ml contains:- Dy No. 2706 400mg/250ml countries not with 250ml
Moxifloxacin hydrochloride dated 16-06- provided.
equivalent to 2016 Local. Barimox
Moxifloxacin……….…..400mg Rs.20,000. 400mg by M/s
Barrett Hodgson.
Antibiotic As per
SRO/1’s
530. M/s Vision Artip 40mg Injection Form 5 Approved
Pharmaceuticals, Local. Artem 40mg
Plot No. 22 & Each ampoule contains:- Dy No. 2703 by M/s Holton
23, Industrial Artemether……….…..40mg dated 16-06- Pharma (PVT)
Triangle Kahuta 2016 Limited
Road, Antimalarial Rs.20,000.
Islamabad.
“Liquid Manufacturer’s Specifications As per
Ampoule SRO/1x5’s &
General 1x10’s
approved in
247th meeting of
CLB.”
531. -do- Artip 80mg Injection Form 5 WHO approved Approved
Each ampoule of 1 ml contains:- Dy No. 2702 Local. Artem 80mg

Artemether……….…..80mg dated 16-06- by M/s Holton
2016 Pharma (PVT)
Antimalarial Rs.20,000. Limited

SRO/1x5’s &
1x10’s
532. -do- Feldex 20mg Injection Form 5 Approval status Deferred for
in reference confirmation
Each ampoule contains:- Dy No. 2705 Local. Pcam 20mg countries is not of approval
Piroxicam……….…..20mg dated 16-06- by M/s Merck (Pvt) provided. status by
2016 Limited reference
NSAID Rs.20,000. regulatory
authorities.
SRO/1x5’s &
1x10’s
533. -do- Doston 4mg Injection Form 5 MHRA. Zofran by Approved
M/s GSK
Each ampoule of 2ml contains:-
Dy No. 2771
Ondansetron hydrochloride
dated 20-06-
equivalent to
2016 Local. Ondiemetic
Ondansetron…….…..4mg
Rs.20,000. 4mg by M/s Zafa
As per Pharmaceuticals
5-HT3 Receptor Antagonist
SRO/1x5’s &
1x10’s
USP Specifications

534. -do- Doston 8mg Injection Form 5 MHRA. Zofran by Approved
M/s GSK
Each ampoule 0f 4ml contains:- Dy No. 2770
Ondansetron hydrochloride dated 20-06- Local. Ondiemetic
equivalent to 2016 8mg by M/s Zafa
Ondansetron…….…..8mg Rs.20,000. Pharmaceuticals
5-HT3 Receptor Antagonist As per

SRO/1x5’s &
USP Specifications 1x10’s
535. -do- Tramax 50mg Injection Form 5 MHRA. Tramadol Approved
by M/s Beacon
Each ampoule of 1ml contains:- Dy No. 2710
Tramadol hydrochloride equivalent dated 16-06- Local. Tramal
to Tramadol…….…..50mg 2016 50mg by M/s
Rs.20,000. Searle Pakistan
Opioid analgesic (Pvt) Limited.
As per
USP Specifications SRO/1x5’s &
1x10’s
536. -do- Spasmax Plus Injection Form 5 The product is Deferred as
under review. product is
Each ampoule contains:- Dy No. 2774 Local. Spadix by under review.
Phloroglucinol dehydrate dated 20-06- M/s Tabros
equivalent to 2016 Pharma.
Phloroglucinol…….40mg Rs.20,000.
Trimethylphloroglucinol….0.04mg
As per
Antispasmodic SRO/1x5’s &
1x10’s
537. -do- Zytec 25mg Injection Form 5 MHRA. Ranitidine Approved
25mg/ml by M/s
Each ampoule of 1ml contains:- Dy No. 2702 Amdipharm
Ranitidine hydrochloride dated 16-06-
equivalent to Ranitidine…….25mg 2016 Local. Ranitidine
Rs.20,000. injection 25mg by
Histamine H2 receptor blocker M/s
As per Glaxosmithkline
1x10’s
538. -do- Pyritec 150mg Injection Form 5 Deferred for
confirmation
Each ampoule 1ml contains:- Dy No. 2712 Local. Pravos of approval
Paracetamol………….150mg dated 16-06- 150mg injection by status by
2016 M/s Sami reference
Analgesic & antipyretic Rs.20,000. Pharmaceuticals regulatory
(Pvt) Limited. authorities.
SRO/1x5’s &
1x10’s
539. -do- Etorac 10mg Injection Form 5 MHRA Deferred for
confirmation
Each ampoule of ml contains:- Dy No. 2049 Local. Toradol of approval
Ketorolac tromethamine equivalent dated 26-05- 10mg injection by status by
to Ketorolac………….10mg 2016 M/s Roche Pakistan reference

Rs.20,000. Limited. regulatory
NSAID authorities.
As per
1x10’s
540. -do- Etorac 30mg Injection Form 5 MHRA. Ketoralac Approved
30mg/ml by M/s
Each ampoule of 1ml contains:- Dy No. 2048 Beacon
Ketorolac tromethamine equivalent dated 26-05-
to Ketorolac………….30mg 2016 Local. Toradol
Rs.20,000. 30mg injection by
NSAID M/s Roche Pakistan
As per Limited.
1x10’s
541. -do- Drotin 40mg Injection Form 5 Approved
Each ampoule of 2ml contains:- Dy No. 2709 Local. NO-SPA

Drotaverine hydrochloride dated 16-06- 40mg injection by
equivalent to 2016 M/s Sanofi Aventis
Drotaverine.……….40mg Rs.20,000. (Pakistan) Limited.
Antispasmodic As per
SRO/1x5’s &
Manufacturer’s Specifications 1x10’s
542. -do- Osteo-D 5mg Injection Form 5 Approved
Each ampoule of 1ml contains:- Dy No. 2047 Local. Calciferol

Cholecalciferol….……….5mg dated 26-05- 5mg injection by
2016 M/s Global
Vitamin Rs.20,000. Pharmaceuticals.
BP Specifications As per
SRO/1x5’s &
1x10’s
543. M/s Vision Indocin 1mg Injection Form 5 FDA approved Deferred as
Pharmaceuticals, product is
Plot No. 22 & Each vial contains:- Dy No. 2711 Local. Liometacen more than 10.
23, Industrial Indomethacin sodium ready to fill dated 16-06- Injection by M/s
Triangle Kahuta powder equivalent to 2016 Chiesi
Road, Indomethacin….……….1mg Rs.20,000. Pharmaceuticals
Islamabad. (Pvt) Limited.
“Sterile Dry NSAID As per
Powder SRO/1’s
Inectable Vials USP Specifications
General
approved in
240th meeting of
CLB.”
544. -do- Viscortin 100mg Injection Form 5 FDA approved Approved
Each vial contains:- Dy No. 2050 Local. Hy-cortisone

Hydrocortisone sodium succinate dated 26-05- 100mg Injection by
ready to fill powder equivalent to 2016 M/s Cirin
Hydrocortisone ….……….100mg Rs.20,000. Pharmaceuticals
(Pvt) Limited.

Glucocorticoid As per
SRO/1’s
USP Specifications

(Pvt) Limited.
SRO/1’s
USP Specifications

(Pvt) Limited.
SRO/1’s
USP Specifications
547. -do- Vanacin 500mg Injection Form 5 MHRA. Approved
Vancomycin
Each vial contains:- Dy No. 2056 500mg by M/s
Vancomycin hydrochloride ready dated 26-05- Actavis
to fill powder equivalent to 2016
Vancomycin….. ….……….500mg Rs.20,000.
Local. Vinjec
Antibiotic As per 500mg Injection by
SRO/1’s M/s Bosch
USP Specifications Pharmaceuticals
(Pvt) Limited.
548. -do- Vanacin 1g Injection Form 5 MHRA. Approved
Vancomycin 1g by
Each vial contains:- Dy No. 2055 M/s Actavis
Vancomycin hydrochloride ready dated 26-05-
to fill powder equivalent to 2016 Local. Vinjec 1g
Vancomycin….. ….……….1g Rs.20,000. Injection by M/s
Bosch
Antibiotic As per Pharmaceuticals
SRO/1’s (Pvt) Limited.
USP Specifications
549. -do- Methlone 500mg Injection Form 5 MHRA. Approved
Methylprednisolone
Each vial contains:- Dy No. 2053 Powder for
Methylprednisolone sodium dated 26-05- injection by M/s
succinate ready to fill powder 2016 Beacon.
equivalent to Methylprednisolone Rs.20,000.
….……….500mg Local. Methylpred
As per 500mg Injection by
Glucocorticoid
SRO/1’s M/s Haji medicine
co.
USP Specifications

550. -do- Methlone 1g Injection Form 5 MHRA. Approved
Methylprednisolone
Each vial contains:- Dy No. 2054 Powder for
Methylprednisolone sodium dated 26-05- injection by M/s
succinate ready to fill powder 2016 Beacon.
equivalent to Methylprednisolone Rs.20,000.
….……….1g Local. Methylpred
As per 1g Injection by M/s
Glucocorticoid SRO/1’s Haji medicine co.
USP Specifications
551. -do- Tigelin 50mg Injection Form 5 MHRA. Tygacil Approved
50mg Powder for
Each vial contains:- Dy No. 2708 infusion by M/s
Tigecycline ready to fill powder dated 16-06- Pfizer
equivalent to 2016
Tigecycline…….……….50g Rs.20,000. Local. Tigecycline
50mg Injection by
Antibiotic As per M/s Wyeth
SRO/1’s Pakistan Limited.
552. M/s Vision Galmet 50mg/500mg Tablet Form 5 TGA. Sobrea by Approved
Pharmaceuticals, M/s Novartis
Plot No. 22 & Each film coated tablet contains:- Dy No. 2714
23, Industrial Vildagliptin….………...50mg dated 16-06- Local. Galvusmet
Triangle Kahuta Metformin hydrochloride 2016 50mg/500mg
Road, equivalent to Rs.20,000. Tablet by M/s
Islamabad. Metformin………..…500mg Novartis Pharma
“Tablet General As per (Pak) Limited.
approved in Antidiabetic SRO/2x7’s
240th meeting of
CLB.” Manufacturer’s Specifications
553. -do- Galmet 50mg/850mg Tablet Form 5 MHRA. Eucrease Approved
by M/s Novartis
Each film coated tablet contains:- Dy No. 2717
Vildagliptin….………...50mg dated 16-06- Local. Galvusmet
Metformin hydrochloride 2016 50mg/500mg
equivalent to Rs.20,000. Tablet by M/s
Metformin………..…850mg Novartis Pharma
As per (Pak) Limited.
Antidiabetic SRO/2x7’s
554. -do- Galmet 50mg/1000mg Tablet Form 5 MHRA. Eucrase by Approved
M/s Novartis
Vildagliptin….………...50mg dated 16-06- Local. Galvusmet
Metformin hydrochloride 2016 50mg/1000mg
equivalent to Rs.20,000. Tablet by M/s
Metformin………..…1000mg Novartis Pharma
As per (Pak) Limited.
Antidiabetic SRO/2x7’s

555. -do- Valent-H 80mg/12.5mg Tablet Form 5 MHRA. Co-Diovan Approved
by M/s Novartis.
Valsartan….………...80mg dated 20-06- Local. Co-Diavan
hydrochlorothiazide…….…12.5mg 2016 80mg/12.5mg
Rs.20,000. Tablet by M/s
Calcium Channel Blocker + Novartis Pharma
Diuretic As per (Pak) Limited.
SRO/2x7’s
USP Specifications
556. -do- Valent-H 160mg/12.5mg Tablet Form 5 MHRA. Co-Diovan Approved
by M/s Novartis
Valsartan….………...160mg dated 20-06- Local. Co-Diavan
hydrochlorothiazide…….…12.5mg 2016 160mg/12.5mg
Calcium Channel Blocker + Novartis Pharma
Diuretic As per (Pak) Limited.
SRO/2x7’s
USP Specifications
557. -do- Valent-H 160mg/25mg Tablet Form 5 MHRA. Co-Diovan Approved
by M/s Novartis
Valsartan….………...160mg dated 20-06- Local. Co Valtec
Hydrochlorothiazide…….…25mg 2016 160mg/25mg
Calcium Channel Blocker + Tabros Pharma.
Diuretic As per
SRO/2x7’s
USP Specifications
558. -do- Co-Valzaar 5mg/80mg Tablet Form 5 MHRA. Exforge by Approved
M/s Novartis
Amlodipine….………...5mg dated 20-06- Local. Amstan
Valsartan………….…80mg 2016 5mg/80mg Tablet
Rs.20,000. by M/s Getz
Angiotensin Receptor Blocker + Pharma (Pvt)
Calcium Channel Blocker As per Limited.
SRO/2x7’s
USP Specifications
M/s Novartis
Valsartan………….…160mg 2016 5mg/160mg Tablet
Rs.20,000. by M/s Getz
SRO/2x7’s
USP Specifications
560. -do- Co-Valzaar 5mg/320mg Tablet Form 5 Deferred for
confirmation
Each film coated tablet contains:- Dy No. 2767 Local. Amstan of approval
Amlodipine….………...5mg dated 20-06- 5mg/320mg Tablet status by
Valsartan………….…320mg 2016 by M/s Getz reference
Rs.20,000. Pharma (Pvt) regulatory

Angiotensin Receptor Blocker + Limited. authorities
Calcium Channel Blocker As per
SRO/2x7’s
USP Specifications
M/s Novartis
Valsartan………….…160mg 2016 10mg/160mg
Rs.20,000. Tablet by M/s Getz
SRO/2x7’s
USP Specifications
562. -do- Co-Valzaar 10mg/320mg Tablet Form 5 Deferred for
confirmation
Each film coated tablet contains:- Dy No. 2765 Local. Amstan of approval
Amlodipine….………...10mg dated 20-06- 10mg/320mg status by
Valsartan………….…320mg 2016 Tablet by M/s Getz reference
Rs.20,000. Pharma (Pvt) regulatory
Angiotensin Receptor Blocker + Limited. authorities
Calcium Channel Blocker As per
SRO/2x7’s
USP Specifications
563. -do- Spasmax 40mg Injection Form 5 The product is Deferred as
under review the product is
Each ampoule of 4ml contains:- Dy No. 2848 Local. Spasfon by under review
Phloroglucinol dehydrate dated 23-06- M/s Hilton Pharma
equivalent to 2016 (Pvt) Limited.
Phloroglucinol…….40mg Rs.20,000.
Antispasmodic As per
SRO/1x5’s &
Manufacturer’s Specifications 1x10’s
564. -do- Form 5 FDA Nubail by M/s Approved
Nalfy Injection 20mg
Endo
Dy No. 2849
Each 01ml ampoule contains:
dated 23-06- Local. Nalbin 20mg
Nalbuphine Hydrochloride eq. to
2016 by M/s Global
Nalbuphine………20mg
Rs.20,000. Pharmaceuticals.
Opioid
As per
SRO/1x5’s &
(Manufacturer’s Specifications )
1x10’s
565. -do- Form 5 FDA Nubail by M/s Approved
Nalfy Injection 10mg
Endo
Dy No. 2850
Each 01ml ampoule contains:
dated 23-06- Local. Nalbin 10mg
Nalbuphine Hydrochloride eq. to
2016 by M/s Global
Nalbuphine………10mg
Rs.20,000. Pharmaceuticals.
Opioid
As per
SRO/1x5’s &
(Manufacturer’s Specifications )
1x10’s

Remaining applications of M/s Sami Pharma, Karachi
566. M/s SAMI ROSERA 5mg Tablets Form 5 EMA: Crestor Fee Rs Approved. Fee
Pharmaceuticals (AstraZeneca) 20,000 is a will be verified
(Pvt.) Limited, Each film coated tablet contains: Rs. 20,000/- FDA: Crestor photocopy. by Budget and
F-95, Off. Hub Rosuvastatin Calcium MS (06-01-2014) (AstraZeneca) Accounts,
River Road, equivalent to DRAP &
S.I.T.E., Rosuvastatin As per SRO Rovista Regn. Chairman
Karachi-75730 ………………………..5mg No. 044043 Registration
(M/s Getz) Board will
(Tablet HMG Reductase Inhibitor permit issuance
General) of registration
Manufacturer’s Specs. letter.
Pharmaceuticals Rs. 20,000/- (AstraZeneca) 20,000 is a will be verified
(Pvt.) Limited, Each film coated tablet contains: (06-01-2014) FDA: Crestor photocopy. by Budget and
F-95, Off. Hub Rosuvastatin Calcium MS (AstraZeneca) Accounts,
River Road, equivalent to As per SRO DRAP &
S.I.T.E., Rosuvastatin Rovista Regn. Chairman
Pharmaceuticals Rs. 20,000/- (AstraZeneca) 20,000 is a will be verified
(Pvt.) Limited, Each film coated tablet contains: (06-01-2014) FDA: Crestor photocopy. by Budget and
F-95, Off. Hub Rosuvastatin Calcium MS (AstraZeneca) Accounts,
River Road, equivalent to As per SRO DRAP &
S.I.T.E., Rosuvastatin Rovista Regn. Chairman
569. M/s SAMI Lenor 8mg Injection Form 5 Approval Deferred for
Pharmaceuticals Each combination pack contain: Acabel Reg. No. status in confirmation of
(Pvt.) Limited, Vial: Dy No.206 061605 (M/s reference approval status
F-95, Off. Hub Lornoxicam MS……….…8mg dated 01-06- Continental countries is by reference
River Road, 2015 Rs. Pharma) not regulatory
S.I.T.E., Ampoule: 20,000/- provided. authorities.
Karachi-75730 Water for Injection
USP……….2ml
(Freeze Dried As per SRO
Products HMG Reductase Inhibitor
General)
Manufacturer’s Specs.

Evaluator-IV Salateen Waseem Philp
New License & New Sections Cases.
New License
address of (Proprietary name + Initial date, diary status in Observations
manufactur Dosage Form + Fee including stringent
er / Strength) differential fee regulatory
Applicant Composition Demanded Price / agencies
Pharmacological Pack size
Group Me-too status
Finished product
Specification GMP status
570. SURGILIN Silk Braided Form 5 with fee Rs Mersilk – Source of Raw Deferred
E 20,000/- vide Dy. # Ethicon, UK braided silk for
A business Silk Braided sterile non 580 dated 16-06- Pearsalls Limited,following
division of absorbable surgical 2016 Ethicon London clarificatio
the licensed suture (all sizes with all mersilk- n:
unit types of needles as per Johnson & Source of needles :-
M/s Vikor USP) Pack size of 12 Johnson Enova® 300 needles,  Docum
Healthcare pieces  (import) a brand of Suturex & entary /
(Pvt.) Ltd, Sutures, Non absorbable RenodexSurgical regulat
Plot # C-126 silk DML # 000834 Needles, France ory
to C-135, USP Specification Silk Suture referen
LIEDA, Hub Section Sterilization :- ces for
District, By Gamma source
Lasbella, irradiations of
Balouchistan braided
silk
and
needle.
 Metho
d of
gamma
radiati
ons
and
agreem
ent.
 Sterilit
y
testing
facility
Demanded Price & Pack size

# Siz Length Curvature Length Point Unit Pack size Price
e/ price per
Ga pack
uge
s
1) 2 76 cm ½ circle 40 mm Round bodies heavy 191.59 12 2299.08
2) 1 76 cm ½ circle 35 mm Taper point 181.82 12 2181.78
3) 1 76 cm Curved 60 mm Curved cutting 181.82 12 2181.78
4) 1 76 cm ½ circle 30 mm Round bodies heavy 181.82 12 2181.78
5) 1 76 cm Straight 60 mm Cutting 181.82 12 2181.78
7) 0 76 cm ½ circle 50 mm Cutting 175.95 12 2111.40
8) 0 76 cm Straight 60 mm Cutting 175.95 12 2111.40
9) 0 1m Straight 75 mm Cutting 175.95 12 2111.40
10) 0 76 cm Curved 45 mm Reverse cutting 175.95 12 2111.40
11) 2/0 45 cm Curved 26 mm Reverse cutting 166.18 12 1994.10
12) 2/0 76 cm ½ circle 26 mm Taper point 166.18 12 1994.10
14) 2/0 76 cm Curved 16 mm Curved cutting 166.18 12 1994.10
15) 2/0 45 cm ½ circle 22 mm cutting 166.18 12 1994.10
18) 2/0 1m Straight 75 mm Cutting 166.18 12 1994.10
20) 2/0 45 cm Curved 26 mm Precision cutting 166.18 12 1994.10
22) 2/0 45 cm ½ circle 25 mm taper point 166.18 12 1994.10
25) 3/0 45 cm Curved 25 mm Slim blade 150.54 12 1806.42
26) 3/0 45 cm 3/8 circle 26 mm Conventional cutting 150.54 12 1806.42
30) 3/0 76 cm 5/8 circle 25 mm Cutting 150.54 12 1806.42
31) 3/0 45 cm ½ circle 22 mm Cutting 150.54 12 1806.42
34) 3/0 76 cm Curved 20 mm Taper point 150.54 12 1806.42
36) 3/0 76 cm Straight 60 mm Straight cutting 150.54 12 1806.42

48) 4/0 45 cm ½ circle 15 mm Slim blade 150.54 12 1806.42
58) 4/0 45 cm curved 26 mm Precision cutting 150.54 12 1806.42
571. SURGILINE Surgigut plain Form 5 with fee Rs Softcat plain Source of Catgut Deferred
A business 20,000/- vide Dy. # BBRAUN plain string for
division of the Plain sterile 559 dated 16-06- USA Locally manufactured following
licensed unit absorbable surgical 2016 at Vikor Healthcare clarificatio
M/s Vikor sutures (all sizes) Catgut – (Pvt.) Ltd under n:
Healthcare (Pvt.) Ethicon license of basic
Ltd, Plot # C-126 Catgut plain sterile Pack size of 12 (Import) manufacturing DML  Docum
to C-135, absorbable surgical pieces  # 000835. entary /
LIEDA, Hub sutures DML # 000834 regulat
District, Lasbella, USP Specification Catgut sutures Source of needles :- ory
Balouchistan (absorbable) Enova® 300 needles, referen
Section a brand of Suturex & ces for
RenodexSurgical source
Needles, France of
needle.
Sterilization :-
 Metho
By Gamma
d of
irradiations
gamma
radiati
ons
and
agreem
ent.
 Sterilit
y
testing
facility
.
 Source
of
catgut
materia

l

# Size / Length Curvature Length Point Unit price Pack size Price per
Gauges pack
1) 1 76 cm ½ circle 40 mm Reverse Cutting 211.14 12 2533.68
6) 0 76 cm Curved 26 mm Curved cutting 191.59 12 2299.08
13) 2/0 76 cm Straight 38 mm Straight cutting 181.82 12 2181.78
14) 2/0 76 cm ½ circle 30 mm cutting 181.82 12 2181.78
15) 3/0 76 cm ½ circle 20 mm Taper Point 168.13 12 2017.56
18) 3/0 76 cm ½ circle 16 mm Cutting 168.13 12 2017.56
19) 3/0 76 cm Curved 26 mm Curved Cutting 168.13 12 2017.56
572. SURGILI Surgigut Chromic Form 5 with fee Rs Softcan Chrom Source of Catgut Deferred
NE 20,000/- vide Dy. # – BBRAUN, plain string for
A business Catgut chromic sterile 558 dated 16-06- USA Locally manufactured following
division of absorbable surgical 2016 at Vikor Healthcare clarificatio
the suture (all sizes) Catgut – (Pvt.) Ltd under n:
licensed Ethicon license of basic
unit Catgut sterile absorbable Pack size of 12 (Import) manufacturing DML  Docum
M/s Vikor surgical sutures pieces  # 000835. entary /
Healthcare USP Specification DML # 000834 Source of needles :- regulat
(Pvt.) Ltd, Catgut sutures Enova® 300 needles, ory
Plot # C- (absorbable) a brand of Suturex & referen
126 to C- Section RenodexSurgical ces for
135, Needles, France source
LIEDA, Sterilization :- of
Hub By Gamma needle.
District, irradiations  Metho
Lasbella,
Balouchista d of
n gamma
radiati

ons
and
agreem
ent.
 Sterilit
y
testing
facility
.
 Source
of
catgut
materia
l
# Size / Length Curvature Length Point Unit Pack size Price per
Gauges price pack
1) 2 76 cm ½ circle Heavy 35 mm Taper cut 232.65 12 2791.74
3) 2 76 cm ½ circle Heavy 40 mm Taper point 232.65 12 2791.74
6) 2 76 cm ½ circle 40 mm Reverse cutting 232.65 12 2791.74
9) 2 76 cm ½ circle Heavy 40 mm Trocar point 232.65 12 2791.74
12) 1 76 cm Curved 45 mm Taper point 220.92 12 2650.98
15) 1 76 cm Curved 63 mm Blunt pint round bodied 220.92 12 2650.98
16) 1 76 cm Curved 85 mm Blunt pint round bodied 220.92 12 2650.98
19) 1 76 cm ½ circle 40 mm Taper cut 220.92 12 2650.98

33) 0 76 cm Straight 40 mm Taper point 211.14 12 2533.68
42) 0 76 cm 5/8 circle 35 mm Taper point 211.14 12 2533.68
47) 0 76 cm ½ circle 45 mm Cutting 211.14 12 2533.68
48) 0 76 cm Hook needle 35 mm Round bodied 211.14 12 2533.68
49) 2/0 76 cm Straight 40 mm Taper point 191.59 12 2299.08
50) 2/0 76 cm Straight 50 mm Taper point 191.59 12 2299.08
56) 2/0 76 cm ½ circle 25 mm Taper cut 191.59 12 2299.08
63) 2/0 76 cm 5/8 circle 60 mm Taper point 191.59 12 2299.08
66) 2/0 76 cm ½ circle heavy 45 mm Taper cut 191.59 12 2299.08
68) 2/0 76 cm ½ circle heavy 25 mm Taper cut 191.59 12 2299.08
69) 2/0 76 cm ½ circle heavy 50 mm Taper point 191.59 12 2299.08
70) 3/0 76 cm ½ circle 26mm Reverse cutting 172.04 12 2064.48
71) 3/0 76 cm Straight 50mm Taper point 172.04 12 2064.48
72) 3/0 76 cm Curved 45mm Taper point 172.04 12 2064.48
73) 3/0 76 cm ½ circle 20mm Taper point 172.04 12 2064.48
75) 3/0 76 cm 5/8 circle 25mm Taper cut 172.04 12 2064.48
76) 3/0 76 cm ½ circle 30mm Taper cutting 172.04 12 2064.48
78) 3/0 76 cm Hook needle 25mm Round bodied 172.04 12 2064.48
80) 4/0 76 cm Curved 16mm Taper point 168.13 12 2017.56

573. M/s Medisol NS IV FORM 5 Sodium Deferred
MEDIPAK Infusion- B.P- Rs 20,000/- Chloride 0.9% for
LIMITED, 24.05.16 IV infusion BP provision
554, Sundar Each 100ml contains. (Baxter Health of approval
Industrial Sodium Chloride….. care Limited status of
Estate, 0.9g Pack size 100ml (UK) formulation
Lahore. Water for Injection q.s plus Eurocap price in same
100ml with single & double Sterifluid NS pack size
(Intravenous injection ports (FDL Limited) by
infusion) Electrolytes Price As per SRO reference
approved in (B.P Specification) DML regulatory
247 th meeting Inspection authorities.
of CLB held dated 16.03.16
on 29.04.16
574. -do- Medisol NS IV FORM 5 Sodium Deferred
Infusion- B.P- Rs 20,000/- Chloride 0.9% for
24.05.16 , IV infusion BP provision
Each 100ml contains. (Baxter Health of approval
Sodium Chloride...... Pack size 250ml care Limited status of
0.9g (UK) formulation
Water for Injection q.s Price =As per SRO in same
100ml plus Eurocap price Sterifluid NS pack size
with single & double (FDL Limited) by
Electrolytes injection ports reference
DML regulatory
(B.P Specs) Inspection authorities.
dated 16.03.16
575. -do- Medisol NS IV FORM 5 Sodium Approved
Infusion- B.P- Rs 20,000/- Chloride 0.9%
24.05.16 , IV infusion BP
Each 100ml contains. (Baxter Health
Sodium Pack size 500ml care Limited
Chloride.......0.9g (UK)
Water for Injection q.s Price =As per SRO
100ml plus Eurocap price Sterifluid NS
with single & double (FDL Limited)
Electrolytes injection ports
DML
(B.P Specs) Inspection
dated 16.03.16
576. -do- Medisol NS IV FORM 5 Sodium Approved
Infusion- B.P- Rs 20,000/- Chloride 0.9%
24.05.16 , IV infusion BP
Each 100ml contains. (Baxter Health
Sodium Pack size 1000ml care Limited
Chloride......0.9g (UK)
Water for Injection q.s Price =As per SRO
100ml plus Eurocap price Sterifluid NS
with single & double (FDL Limited)
Electrolytes injection ports
DML

(B.P Specs) Inspection
dated 16.03.16
577. -do- Ciprofena IV Infusion FORM 5 Ciprofloxacin Approved

B.P Rs 20,000/- solution for
24.05.16 , Infusion
Each 100ml contains. (MHRA)
Ciprofloxacin as Pack size 100ml
lactate....200mg Ciproxin IV
Price =As per SRO Infusion (Bayer
Antibiotic plus Eurocap price Healthcare)
(B.P Specs) with single & double
injection ports DML
Inspection
dated 16.03.16
578. -do- Ciprofena IV Infusion FORM 5 Ciprofloxacin Deferred
B.P Rs 20,000/- solution for for
24.05.16 , Infusion provision
Each 100ml contains. (MHRA) of approval
Ciprofloxacin as status of
lactate....200mg Pack size 250ml Ciproxin IV formulation
Water for Injection q.s plus Eurocap price Infusion (Bayer in same
....100ml with single & double Healthcare) pack size
injection ports by
Antibiotic Price =As per SRO DML reference
(B.P Specs) Inspection regulatory
dated 16.03.16 authorities
and
Pakistan.
579. Aquasteril -water for FORM 5 Water for Deferred
injection)BP- Rs 20,000/- Injection for
24.05.16 , Antigen provision
International of approval
Each 100ml contains. Pack size 100ml Ltd Auckland- status of
Water for Injection New Zeeland formulation
100ml Price =As per SRO (MHRA) in same
Diluent for Admixing plus Eurocap price pack size
with single & double Water for by
(BP Specs) injection ports injection reference
(Otsuka Pvt regulatory
Limited) authorities
and
Pakistan
and with
intended
use in this
pack size.
580. Aquasteril -water for FORM 5 Water for Deferred
Each 100ml contains. International of approval

Water for Injection Pack size 250ml Ltd Auckland- status of
100ml New Zeeland formulation
Price =As per SRO (MHRA) in same
and
Pakistan
and with
intended
use in this
pack size.
581. Aquasteril (water for FORM 5 Water for Deferred
and
Pakistan
and with
intended
use in this
pack size.
582. Aquasteril (water for FORM 5 Water for Deferred
injection ports injection reference
(BP Specs) (Otsuka Pvt regulatory
and
Pakistan
and with
intended
use in this
pack size.

583. Medisol 5% IV FORM 5 Dextrose IV Deferred
Infusion—B.P Rs 20,000/- Infusion for
24.05.16 , (B. Braun) provision
Each 100ml contains. of approval
Dextrose Pack size 100ml status of
Anhydrous....5g Sterifluid -5 formulation
Water for Injection q.s Price =As per SRO (FDL Limited) in same
....100ml plus Eurocap price DML pack size
with single & double Inspection by
Carbohydrates injection ports dated 16.03.16 reference
regulatories
(B.P Specs) authorities
and
Pakistan.
584. Medisol 5% IV FORM 5 Dextrose IV Deferred
Infusion—B.P Rs 20,000/- Infusion for
24.05.16 , (B. Braun) provision
Each 100ml contains. of approval
Dextrose Pack size 250ml status of
Anhydrous....5g Sterifluid -5 formulation
Water for Injection q.s Price =As per SRO (FDL Limited) in same
....100ml plus Eurocap price pack size
with single & double by
Carbohydrates injection ports reference
(B.P Specs) regulatories
authorities
and
Pakistan.
585. Medisol 5% IV FORM 5 Dextrose IV Approved
Infusion—B.P Rs 20,000/- Infusion
24.05.16 , (B. Braun)
Each 100ml contains.
Dextrose Pack size 500ml
Anhydrous....5g Sterifluid -5
Water for Injection q.s Price =As per SRO (FDL Limited)
....100ml plus Eurocap price
with single & double DML
Carbohydrates injection ports Inspection
dated 16.03.16
(B.P Specs)
586. Medisol 5% IV FORM 5 Dextrose IV Approved
Infusion—B.P Rs 20,000/- Infusion
24.05.16 , (B. Braun)
Each 100ml contains.
Dextrose
Pack size 1000ml
Anhydrous....5g
Sterifluid -5
Water for Injection q.s
Price =As per SRO (FDL Limited)
....100ml
plus Eurocap price
Carbohydrates with single & double DML
injection ports Inspection
(B.P Specs) dated 16.03.16

587. Medigyl Injection B.P – FORM 5 Metronidazole Approved
Rs 20,000/- Infusion
Each 100ml contains. 24.05.16 , AFT Pharma
Metronidazole....0.5g New Zeeland
Water for Injection q.s Pack size 100ml
....100ml
Price =As per SRO Flagyl
Anti amoebic plus Eurocap price Injection
with single & double (Sanofi)
(B.P Specs) injection ports
DML
Inspection
dated 16.03.16
588. Medigyl Injection B.P – FORM 5 Metronidazole Deferred
Rs 20,000/- Infusion for
Each 100ml contains. 24.05.16 , AFT Pharma provision
Metronidazole....0.5g New Zeeland of approval
Water for Injection q.s Pack size 250ml status of
....100ml formulation
Price =As per SRO Flagyl in same
Anti amoebic plus Eurocap price Injection pack size
with single & double (Sanofi) by
(B.P Specs) injection ports reference
DML regulatories
Inspection authorities
dated 16.03.16 and
Pakistan.
589. Medisol-S IV FORM 5 Sterifluid 0.9% Deferred
Infusion—B.P Rs 20,000/- Glucose 5% for
24.05.16 , Baxter provision
Each 100ml contains. Healthcare Ltd- of approval
1. Sodium Pack size 100ml UK) status of
Chloride...0.9g formulation
2. Dextrose Price =As per SRO Sterifluid DS in same
Anhydrous...5g plus Eurocap price (FDL) pack size
3. Water for Injection with single & double by
Q.S. injection ports DML reference
Inspection regulatories
Electrolytes + dated 16.03.16 authorities
carbohydrates and
Pakistan.
B.P specs

590. Medisol-S IV FORM 5 Sterifluid 0.9% Deferred
Infusion—B.P Rs 20,000/- Glucose 5% for
24.05.16 , Baxter provision
Each 100ml contains. Healthcare Ltd- of approval
1. Sodium Pack size 250ml UK) status of
2. Dextrose Price =As per SRO Sterifluid DS in same
Anhydrous...5g plus Eurocap price (FDL) pack size
3. Water for Injection with single & double by
Q.S. injection ports DML reference
Inspection regulatories
Electrolytes + dated 16.03.16 authorities
carbohydrates and
Pakistan.
B.P specs
591. Medisol-S IV FORM 5 Sterifluid 0.9% Approved
Infusion—B.P Rs 20,000/- Glucose 5%
24.05.16 Baxter
Each 100ml contains. Healthcare Ltd-
1. Sodium Pack size 500ml UK)
Chloride...0.9g
2. Dextrose Price =As per SRO Sterifluid DS
Anhydrous...5g plus Eurocap price (FDL)
3. Water for Injection with single & double
Q.S. injection ports DML
Inspection
Electrolytes + dated 16.03.16
carbohydrates
B.P specs
592. Medisol-S IV FORM 5 Sterifluid 0.9% Approved
Infusion—B.P Rs 20,000/- Glucose 5%
24.05.16 , Baxter
Each 100ml contains. Healthcare Ltd-
1. Sodium Pack size 1000ml UK)
Chloride...0.9g
2. Dextrose Price =As per SRO Sterifluid DS
Anhydrous...5g plus Eurocap price (FDL)
3. Water for Injection with single & double
Q.S. injection ports DML
Inspection
Electrolytes + dated 16.03.16
carbohydrates
B.P specs

593. Medisol Hartmann’s FORM 5 Compound Deferred
(Compound Sodium Rs 20,000/- Sodium Lactate for
Lactate) 24.05.16 , solution for provision
IV Infusion—B.P Infusion of approval
Pack size 100ml (Baxter status of
Each 100ml contains. Healthcare Ltd- formulation
1. Sodium Chloride... Price =As per SRO UK) in same
0.6g plus Eurocap price pack size
2. Potassium Chloride... with single & double Sterifluid –RL by
0.04g injection ports (FDL Limited) reference
3. Calcium Chloride. DML regulatories
2H2O.. 0.027g Inspection authorities
4. Sodium Lactate (50% dated 16.03.16 and
solution).. 0.64g Pakistan
5. Water for Injection and
Q.S..100ml clarificatio
n for use
Electrolytes of sodium
lactate in
(B.P Specs) 50%
solution
form
3. Calcium Chloride. regulatories
2H2O.. 0.027g DML authorities
4. Sodium Lactate (50% Inspection and
solution).. 0.64g dated 16.03.16 Pakistan
Electrolytes n for use
of sodium
(B.P Specs) lactate in
50%
solution
form

3. Calcium Chloride. regulatories
2H2O.. 0.027g DML authorities
4. Sodium Lactate (50% Inspection and
solution).. 0.64g dated 16.03.16 Pakistan
n for use
Electrolytes of sodium
(B.P Specs) lactate in
50%
solution
form
Each 100ml contains. Pack size 1000ml (Baxter status of
Healthcare Ltd- formulation
Each 100ml contains. Price =As per SRO UK) in same
1. Sodium Chloride... plus Eurocap price pack size
0.6g with single & double Sterifluid –RL by
2. Potassium Chloride... injection ports (FDL Limited) reference
0.04g regulatories
3. Calcium Chloride. DML authorities
2H2O.. 0.027g Inspection and
4. Sodium Lactate (50% dated 16.03.16 Pakistan
solution).. 0.64g and
5. Water for Injection clarificatio
Q.S..100ml n for use
of sodium
Electrolytes lactate in
50%
(B.P Specs) solution
form

597. Medisol Paeds IV FORM 5 0.18% sodium Deferred
Infusion B.P Rs 20,000/- chloride , for
24.05.16 , 4% glucose provision
Each 100ml contains. B Braun of approval
1. Sodium Pack size 100ml Germany. status of
2. Dextrose Price =As per SRO Sterifluid in same
Anhydrous...4.3g plus Eurocap price Paeds (FDL pack size
3. Water for Injection with single & double Limited) by
Q.S...100ml injection ports reference
DML regulatories
Electrolytes + Inspection authorities
carbohydrates dated 16.03.16 and
Pakistan.
B.P Specs
598. Medisol Paeds IV FORM 5 0.18% sodium Deferred
Infusion B.P Rs 20,000/- chloride , for
Each 100ml contains. 24.05.16 , 4% glucose provision
1. Sodium B Braun of approval
Chloride...0.18g Pack size 250ml Germany. status of
2. Dextrose formulation
Anhydrous...4.3g Price =As per SRO Sterifluid in same
3. Water for Injection plus Eurocap price Paeds (FDL pack size
Q.S...100ml with single & double Limited) by
injection ports reference
Electrolytes + DML regulatories
carbohydrates Inspection authorities
dated 16.03.16 and
B.P Specs Pakistan.
599. Medisol Paeds IV FORM 5 0.18% sodium Approved
Infusion B.P Rs 20,000/- chloride ,
24.05.16 , 4% glucose
Each 100ml contains. B Braun
1. Sodium Pack size 500ml Germany.
Chloride...0.18g
2. Dextrose Price =As per SRO Sterifluid
Anhydrous...4.3g plus Eurocap price Paeds (FDL
3. Water for Injection with single & double Limited)
Q.S...100ml injection ports
DML
Electrolytes + Inspection
carbohydrates dated 16.03.16
B.P Specs

600. Medisol Paeds IV FORM 5 0.18% sodium Approved
Infusion B.P Rs 20,000/- chloride ,
24.05.16 , 4% glucose
Each 100ml contains. B Braun
1. Sodium Pack size 1000ml Germany.
Chloride...0.18g
2. Dextrose Price =As per SRO Sterifluid
Anhydrous...4.3g plus Eurocap price Paeds (FDL
3. Water for Injection with single & double Limited)
Q.S...100ml injection ports
DML
Electrolytes + Inspection
carbohydrates dated 16.03.16
B.P Specs
601. Medisol ½ NS (Sodium FORM 5 Sodium Deferred
Chloride 0.45%) Rs 20,000/- Chloride for
Injection USP 24.05.16 , Injection provision
0.45% (Hospira of approval
Each 100ml contains. Pack size 100ml USA) status of
Sodium Chloride............ formulation
0.45g Price =As per SRO Nisf Normal in same
Water for Injection q.s plus Eurocap price Saline pack size
....100ml with single & double (Otsuka by
injection ports Limited) reference
Electrolytes regulatories
DML authorities
Inspection and
(USP Specs) dated 16.03.16 Pakistan.
602. Medisol ½ NS (Sodium FORM 5 Sodium Deferred
Chloride 0.45%) Rs 20,000/- Chloride for
Injection USP 24.05.16 , Injection provision
0.45% (Hospira of approval
Each 100ml contains. Pack size 250ml USA) status of
Sodium Chloride............ formulation
0.45g Price =As per SRO Nisf Normal in same
Water for Injection q.s plus Eurocap price Saline pack size
....100ml with single & double (Otsuka by
injection ports Limited) reference
Electrolytes regulatories
DML authorities
(USP Specs) Inspection and
dated 16.03.16 Pakistan.

603. Medisol ½ NS (Sodium FORM 5 Sodium Approved
Chloride 0.45%) Rs 20,000/- Chloride
Injection USP 24.05.16 , Injection
0.45% (Hospira
Each 100ml contains. Pack size 500ml USA)
Sodium Chloride............
0.45g Price =As per SRO Nisf Normal
Water for Injection q.s plus Eurocap price Saline
....100ml with single & double (Otsuka
injection ports Limited)
Electrolytes
DML
(USP Specs) Inspection
dated 16.03.16
604. Medisol ½ NS (Sodium FORM 5 Sodium Approved
Chloride 0.45%) Rs 20,000/- Chloride
Injection USP 24.05.16 , Injection
0.45% (Hospira
Each 100ml contains. Pack size 1000ml USA)
Sodium Chloride............
0.45g Price =As per SRO Nisf Normal
Water for Injection q.s plus Eurocap price Saline
....100ml with single & double (Otsuka
injection ports Limited)
Electrolytes
DML
(USP Specs) Inspection
dated 16.03.16
605. Medilact-D Solution for FORM 5 Lactated Deferred
Injection-USP Rs 20,000/- Ringer & for
24.05.16 , Dextrose provision
Each 100ml contains. Injection of approval
1. Sodium Chloride... Pack size 100ml Baxter status of
0.6g Healthcare formulation
2. Potassium Chloride ... Price =As per SRO Corporation- in same
0.03g plus Eurocap price USA pack size
3. Calcium Chloride. with single & double by
2H2O... 0.02g injection ports Sterifluid RLD reference
4. Sodium Lactate (50% (FDL Limited) regulatories
solution)... 0.620g authorities
5. Dextrose DML and
Monohydrate... 5.0g Inspection Pakistan
6. Water for Injection dated 16.03.16 and
Q.S...100ml clarificatio
n for use
Electrolytes + of sodium
carbohydrates lactate in
50%
USP Specs solution
form

1. Sodium Chloride... Pack size 250ml Baxter status of
5. Dextrose DML and
n for use
50%
USP Specs solution
form
1. Sodium Chloride... Pack size 500ml Baxter status of
5. Dextrose DML and
n for use
50%
USP Specs solution
form

Sodium Chloride 0Each Injection of approval
100ml contains. Pack size 1000ml Baxter status of
1. Sodium Chloride... Healthcare formulation
0.6g Price =As per SRO Corporation- in same
2. Potassium Chloride ... plus Eurocap price USA pack size
0.03g with single & double by
3. Calcium Chloride. injection ports Sterifluid RLD reference
2H2O... 0.02g (FDL Limited) regulatories
4. Sodium Lactate (50% authorities
solution)... 0.620g DML and
5. Dextrose Inspection Pakistan
Monohydrate... 5.0g dated 16.03.16 and
6. Water for Injection clarificatio
Q.S...100ml n for use
of sodium
lactate in
50%
Electrolytes + solution
carbohydrates form
USP Specs
Tablet (General)
609. M/s Jupiter Tablet Anatrin Form 5 MHRA Approved
Pharma Rs. 20000/- approved
Plot # 25, St# Each tablet contains (13-06-2016) Aratoin – Dr.
S6 RCCI Nitrofurantoin 100 mg Dy.No 2653 Reddy, UK
Rawat (BP).
Rawalpindi. Furadin
Antibacterial Pack of 10 x 10’s (Ferozsons)
Tablet BP Specification  as per DPC
(General)
Approved in
247th meeting
of central
licensing
board held on
29-04-2016
610. -do- Tablet Jucip 250 Form 5 MHRA Approved
Rs. 20000/- approved brand
Each film coated tablet (13-06-2016) of Dr. Reddy,
contains Dy.No 2652 UK
Ciprofloxacin (as
HCl.2H2O) 250mg. Pack of 1x 10’s  Novidat - Sami
as per DPC
Antibiotics
(USP Specification)

611. -do- Tablet Jucip 500 Form 5 MHRA Approved
Each film coated tablet (13-06-2016) of Dr. Reddy,
contains Dy.No 2650 UK
Ciprofloxacin (as
HCl.2H2O) 500mg Pack of 1x 10’s Novidat - Sami
 as per DPC
Antibiotics
(USP Specification)
612. -do- Tablet Julin 250 Form 5 MHRA Approved

Rs. 20000/- approved
Each film coated tablet (13-06-2016) Evoxil –
contains Dy.No 2649 Beacon
Levofloxacin (as
hemihydrate ) 250mg Pack of 1x 10’s Leflox-Getz
 as per DPC
Quinolones
(Jupiter’s Specs)
613. -do- Tablet Julin -500 Form 5 MHRA Approved

Each film coated tablet (13-06-2016) Evoxil –
contains Dy.No 2651 Beacon
Levofloxacin (as
hemihydrate) 500mg Leflox-Getz
Pack of 1x 10’s
Quinolones  as per DPC
(Jupiter’s Specs)
614. -do- Tablet Jukast 5 Form 5 MHRA Approved

Each chewable tablet (13-06-2016) of Aurobindo
contains Dy.No 2647
Montelukast (as sodium) Montika-Sami
5mg Pack of 2x 7’s
 as per DPC
Anti-asthmatic
(Jupiter’s Specs)
615. -do- Tablet Jukast -10 Form 5 MHRA Approved

Each film coated tablet (13-06-2016) Singulair –
contains Dy.No 2648 Merck
Montelukast (as
sodium) 10mg Pack of 2x 7’s Singulair -
 as per DPC OBS
(Jupiter’s Specs)
Anti-asthmatic

616. -do- Tablet Mozter 400mg Form 5 MHRA Approved
Each film coated tablet (13-06-2016) Avelox
contains Dy.No 2642
Moxifloxacin HCl USP Moxiget -Getz
eq. to Moxifloxacin 400 Pack of 1x 5’s
mg  as per DPC
quinolone antibiotic
(Manufacture Specs)
617. -do- Tablet Resjun-1 Form 5 MHRA Approved

Each film coated tablet (13-06-2016) Risperdal –
contains Dy.No 2643 Janssen
Risperidone 1mg
Benzisox -
Benzisoxazole Pack of 2x 10’s Highnoon
derivatives  as per DPC
(USP Specs)
618. -do- Tablet Resjun -2 Form 5 MHRA Approved

Riperidone 2mg
Pack of 2x 10’s Benzisox -
Benzisoxazole  as per DPC Highnoon
derivatives (USP Specs)
619. -do- Tablet Resjun -3 Form 5 MHRA Approved

Riperidone 3mg
620. -do- Tablet Resjun-4 Form 5 MHRA Approved

Riperidone 4mg

621. -do- Tablet Pirujin Form 5 Tablet Brexine Approved
Rs. 20000/- 20mg –Chiesi –
Each tablet Contains (13-06-2016) France
Piroxicam B Dy.No 2665
cyclodextrin 191.2mg eq Brexin -Chiesi
to Piroxicam 20mg Pack of 2x 10’s
 as per DPC
Analgesics, antipyretics
(Jupiter’s specs)
622. -do- Tablet Marlin Form 5 WHO Approved

Rs. 20000/- recommended
Each tablet contains (13-06-2016) formulation
Artemether ..20mg Dy.No 2636
Lumefentrine 120mg Artem -Hilton
(Jupiter’s specs) Pack of 2x 8’s

Antimalarial  as per DPC
623. -do- Tablet Marlin Fort Form 5 WHO Approved

Pack of 1x 8’s
(Jupiter’s specs)  as per DPC
Antimalarial
624. -do- Tablet Marlin DS Form 5 WHO Approved

Pack of 1x 6’s
(Jupiter’s specs)  as per DPC
Antimalarial
625. -do- Tablet J-Rox CR 12.5 Form 5 USFDA Approved

Rs. 20000/- Paxil SR-GSK
Each enteric film coated (13-06-2016)
controlled released Dy.No 2654 Seroxat CR-
tablet contains GSK
Paroxetin as HCl
12.5mg Pack of 1x 10’s
 as per DPC
(Jupiter’s specs)
SSRIs

626. -do- Tablet J-Rox CR 25 Form 5 USFDA Approved
Rs. 20000/- Paxil SR-GSK
Each enteric film coated (13-06-2016)
controlled released Dy.No 2663 Seroxat CR-
tablet contains GSK
Paroxetin as HCl 25mg Pack of 1x 10’s
 as per DPC
(Jupiter’s specs)
SSRI
627. -do- Tablet Amlodine 5/80 Form 5 MHRA Approved

Each film coated tablet (13-06-2016) Exforge-
contains Amlodipine (as Dy.No 2659 Novartis
besylate) 5mg
Valsartan 80mg Pack of 14’s Exforge –
 as per DPC Novartis
(Jupiter’s specs)
Calcium channel
blocker.
Angiotensis II (AT1)
receptor antagonist

contains Dy.No 2660 Novartis
5mg Exforge –
Valsartan 160mg Pack of 14’s Novartis
 as per DPC
(Jupiter’s specs)
Calcium channel
blocker.
receptor antagonist.
contains Dy.No 2657 Novartis
10mg Exforge –
Valsartan 160mg Pack of 14’s Novartis
 as per DPC
(Jupiter’s specs)
Calcium channel
blocker.
receptor antagonist.

630. -do- Tablet Judol Form 5 Adela - getz Deferred as
Rs. 20000/- 10
Each tablet contains (13-06-2016) molecules
Alfacalcidol 0.5mcg Dy.No 2650 per section
has already
(Jupiter’s specs) Pack of 1 x 10’s been
Vitamin –D Analogue  as per DPC approved
631. -do- Mides Form 5 MHRA Deferred as

Rs. 20000/- approved brand 10
Each film coated tablet (13-06-2016) of Consilient molecules
contains Dy.No 2655 per section
Desloratadine 5mg Alenor – has already
Pack of 1 x 10’s Macter been
( Jupiter’s specs).  as per DPC approved
Antihistamine
632. -do- Tablet Jubal Form 5 Methycobal – Deferred as

Rs. 20000/- Eisai, Japan 10
Each sugar coated tablet (13-06-2016) molecules
contains Dy.No 2658 per section
Mecobalamin 500 mcg Anemovit - has already
Pharmacare been
Vitamin B-12 Pack of 3x 10’s approved
Manufacture  as per DPC
Specification
Capsule (General)
633. M/s Jupiter Capsule Jutrazole Form 5 MHRA Approved
Pharma Rs. 20000/- approved
Plot # 25, St# Each capsule contains (13-06-2016) Azocan-P,
S6 RCCI Fluconazole 150mg Dy.No 2641 FDC
Rawat
Rawalpindi. Synthetic Axicon - Axis
azole/Systemic Pack of 1x 1’s
Capsule antifungal agent  as per DPC
(General) (Jupiter’s Specs)
Approved in
247th meeting
of central
licensing

board held on
29-04-2016
634. -do- Capsule J-Baline-50 Form 5 US FDA Approved

Rs. 20000/- LYRICA
Each capsule contains (13-06-2016) Capsules (25,
Pregabalin 50mg Dy.No 2621 50, 75, 100,
150,200, 225
(Jupiter’s specs) and 300mg)
anti-epileptic drug, also Pack of 3x 10’s
called an anticonvulsant  as per DPC ZEEGAP
agent. Capsules (25,
50, 75, 100 and
150mg)
Hilton
635. -do- Capsule J-Baline -75 Form 5 US FDA Approved

Rs. 20000/- LYRICA
Pregabaline 75mg Dy.No 2622 50, 75, 100,
150,200, 225
(Jupiter’s specs) Pack of 3x 10’s and 300mg)
anti-epileptic drug, also  as per DPC
called an anticonvulsant ZEEGAP
50, 75, 100 and
150mg)
Hilton
636. -do- Capsule J-Baline-100 Form 5 US FDA Approved

Rs. 20000/- LYRICA
Pregabaline 100mg Dy.No 2629 50, 75, 100,
150,200, 225
(Jupiter’s specs) and 300mg)
anti-epileptic drug, also Pack of 3x 10’s
called an anticonvulsant  as per DPC ZEEGAP
50, 75, 100 and
150mg)
Hilton

637. -do- Capsule Tamsel 400mcg Form 5 MHRA Approved
Rs. 20000+30000= approved
Each capsule contains 50000 Tabphyn-
Tamsulosin HCl (as (13-06-2016) Genus
modified released (17-06-2016)
pellets 0.2 %) eq to Dy.No 2630 Alfamax -
Tamsulosine 0.4mg Platinum
(Jupiter’s Specs) Pack of 1x 10’s

α1-Adrenergic blocking  as per DPC
agent with selectivity for
α1A-adrenergic receptors
Source of pellets:-
M/s Vision
Pharmaceuticals, Kahuta
road, Islamabad.
638. -do- Capsule Azoter Form 5 MHRA Approved

Each capsule contains (13-06-2016) Zithromax –
Azithromycin (as Dy.No 2631 Pfizer
dehydrate) 250mg
Azelide-Hygeia
(USP Specs) Pack of 1x 10’s
Macrolide Antibiotic  as per DPC
agent.
639. -do- Capsule Mebal Form 5 Innovit - Proof of approval Deferred

Rs. 20000/- Werrick status of same dosage for
Each capsule contains (13-06-2016) form in reference approval
Mecobalamine 500mcg Dy.No 2637 countries not given. status of
same
(Jupiter’s specs) dosage
Antianemic agent Pack of 2x 10’s form in
 as per DPC reference
countries.
640. -do- Capsule Jucam Form 5 MHRA Approved

Each capsule contains (13-06-2016) feldene-Pfizer
Piroxicam 20mg Dy.No 2633
Feldene -Pfizer
(USP Specs)
NSAID Pack of 2x 10’s
 as per DPC

641. -do- Capsule Judep Plus Form 5 USFDA Approved
Rs. 20000/- SYMBAX
Each capsule contains (13-06-2016)
Fluoxetine (as HCl) 25 Dy.No 2623 Co-Depricap,
mg Olanzopine 6mg NabiQasim
(USP specs) Pack of 2x 10’s

Antidepressent  as per DPC
642. -do- Capsule Lansjup 30mg Form 5 MHRA Approved

Each capsule contains (13-06-2016) of Consilient
Lansoprazole (as enteric Dy.No 2624
coated pellets 8.5% ) eq Doudcer-nil -
to Lansoprazole 30mg Global
Pack of 14’s
(USP Specs)  as per DPC
Proton Pump Inhibitor
Source of pellets:-
M/s Vision
Road, Islamabad.
643. -do- Capsulr Esojup-20 Form 5 MHRA Approved

Each capsule contains (13-06-2016) Emozul-
Esomeprazol(as Dy.No 2628 Consilient
Megnesium trihydrate
enteric coated pellet ESSO-Shaigan
22.5% ) eq to Pack of 14’s
Esomeprazole 20mg  per DPC
(Jupiter’s Specs)
Source of pellets:-
M/s Vision
Road, Islamabad.

644. -do- Capsule Esojup- 40 Form 5 MHRA Approved
Each capsule contains (13-06-2016) Emozul-
Esomeprazole (as Dy.No 2625 Consilient
Megnesium trihydrate
enteric coated pellet ESSO-Shaigan
22.5% ) eq to Pack of 14’s
Esomeprazole 40mg  as per DPC Source of
pellets:-
(Jupiter’s Specs) M/s Vision
Proton Pump Inhibitor Pharmaceutical
s, Kahuta
Road,
Islamabad.
645. -do- Capsule Jumep -20 Form 5 MHRA Approved
Each capsule contains (13-06-2016) Losec –
omeprazol(enteric Dy.No 2627 AstraZeneca
coated pellet 8.5 ) eq to
omeprazole 20mg Risek-Getz
Pack of
(USP Specs) 14’s  as per DPC
Source of pellets:-
M/s Vision
Road, Islamabad.
646. -do- Capsule Jumep- 40 Form 5 MHRA Approved

Each capsule contains (13-06-2016) Losec –
omeprazole (enteric Dy.No 2626 AstraZeneca
coated pellet 8.5) eq to
omeprazole 40mg Risek-Getz
Pack of 14’s
(USP Specs)  per DPC
Source of pellets:-
M/s Vision
Road, Islamabad.

Oral Dry Powder Suspension
647. M/s Jupiter Azoter Dry Powder for Form 5 MHRA Approved
Pharma Suspension Rs. 20000/- approved brand
Plot # 25, St# (13-06-2016) of Sandoz
S6 RCCI Each 5ml of Dy.No 2634
Rawat reconstituted suspension Azomax -
Rawalpindi. contains Azithromycin Novartis
(as dehydrate) 200mg Pack of 15ml
 as per DPC
Dry Powder ( USP Specs)
Suspension Macrolide Antibiotic
(General) agent.
Approved in
247th meeting
of central
licensing
board held on
29-04-2016
648. -do- Marlin Suspension Form 5 WHO Approved
15/90 Rs. 20000/- recommended
(13-06-2016) formulation
Each 5ml of Dy.No 2661
reconstituted suspension Artem - Hilton
contains Artemether
15mg Lumefentrine Pack of 60ml  as
90mg per DPC
(jupiter’s specs)
Anti malarial
649. -do- Marlin DS Suspension Form 5 WHO Approved
30/180 Rs. 20000/- recommended
(13-06-2016) formulation
Each 5ml of Dy.No
reconstituted suspension Artem - Hilton
contains Artemether
30mg Lumefentrine Pack of 60ml
180mg  as per DPC
(jupiter’s specs)
Anti malarial
650. -do- Clariter Oral Drops Form 5 MHRA Approved
Each 5ml of (13-06-2016) of Sandoz
reconstituted suspension Dy.No 2637
contains Klaricid –
Clarithromycin 125mg Abbott
Granules for suspension Pack of 60ml
 as per DPC
Macrolide Antibiotic
agent.
(USP Specs)

651. -do- J-Linz Suspension Form 5 USFDA Zyvox Approved
Rs. 20000/- –Pharmacia
Each 5ml reconstituted (13-06-2016) upjouhn
suspension contains Dy.No 2638
Linezolid 100 mg Nezocin -
Powder for suspension brookes
Pack of 60ml
(Jupiter’s Specs)  as per DPC
synthetic antibiotic, the
first of the
oxazolidinone class
652. -do- Jutrazole Dry Form 5 MHRA Approved

Suspension Rs. 20000/- Diflucan –
(13-06-2016) Pfizer
Each 5ml reconstituted Dy.No 2639
suspension contains Diflucan -
Fluconazole 50 mg Pfizer
Pack of 35ml
(USP Specs)  as per DPC
Synthetic
azole/Systemic
antifungal agent.
653. -do- Zincter Suspension Form 5 WHO Product under review Deferred as
Rs. 20000/- recommended as waiting for reply Product is
Each 5ml reconstituted (13-06-2016) formulation from WHO. under
suspension contains Dy.No 2640 review and
Zinc sulphate Zincat sent for
monohydrate eq to comments
Elemental Zinc 20 mg Pack of 60ml of WHO.
 as per DPC
(Jupiter’s Specs)
Zinc supplement

New License of M/s Regal Pharmaceuticals, Plot # 2-A, Street # S-5 National industrial zone Rawat-
Islamabad
S/N Name and Brand Name Type of Form International Remarks Decision
address of (Proprietary name + Initial date, status in reference
manufacturer / Dosage Form + diary drug agencies /
Applicant Strength) Fee including authorities
Composition differential fee Me-too status
Pharmacological Demanded Price GMP status as
Group / Pack size depicted in latest
Finished product inspection report
Specification (with date) by the

Evaluator
Tablet (General)
654. M/s Regal Regcam Tablet 4 mg Form 5 EMA approved Approved
Pharmaceuticals, Rs. 20,000/- Brand Xefo
Plot # 2-A, Street Each film coated 08-06-2016
# S-5 National tablet contains: Dy. No. 2460 Loricam - Saffron
industrial zone Lornoxicam 4 mg
Rawat-
Islamabad (Regal Spec) Pack of
NSAID. 10’s/as per DPC
DML of firm 20’s / as per DPC
approved in 247st 30’s / as per DPC
meeting of
Central
Licensing Board
held on 29-04-
2016.
655. -do- Regcam Tablet 8 mg Form 5 EMA approved Approved

Rs. 20,000/- Brand Xefo
Each film coated 08-06-2016
tablet contains: Dy. No. 2462 Loricam - Saffron
Lornoxicam 8 mg
(Regal Spec) Pack of 10’s/as

NSAID. per DPC
20’s / as per DPC
30’s / as per DPC
656. -do- Regoxin CR Tablet Form 5 FDA approved Approved

12.5 mg Rs. 20,000/- Paxil CR - GSK
08-06-2016
Each enteric coated Dy. No. 2457 Tablet Deroxat
controlled release 12.5 mg by
tablet contains: Gobal pharma
Paroxetine Hcl eq to Pack of 10’s/as
Paroxetine 12.5mg per DPC
20’s / as per DPC
(USP Spec) 30’s / as per DPC
SSRI
657. -do- Regoxin CR Tablet Form 5 FDA approved Approved

25 mg Rs. 20,000/- Paxil CR- GSK
08-06-2016
Each enteric coated Dy. No. 2461
controlled release Tablet Deroxat
tablet contains: Pack of 10’s/as 12.5 mg by
Paroxetine Hcl eq to per DPC Gobal pharma
Paroxetine 25mg 20’s / as per DPC
30’s / as per DPC
(USP Spec)
SSRI

658. -do- Dinac Tablet 50 mg Form 5 FDA approved Proof of Double Deferred for
Rs. 20,000/- Arthrotec – health punch  Confirmation
Each Delayed release 08-06-2016 care UK. compression by FID for
tablet contains: Dy. No. 2458 machine. double punch
Diclofenac sodium Erwin –Sami compression
50mg + Complete machine.
Misoprostol 200mcg Pack of 10’s/as description of  Complete
per DPC dosage form description of
(Regal Spec) 20’s / as per DPC required. dosage form
Pain reliever required.
Firm needs to  Firm needs to
follow innovator follow
brand innovator
formulation. brand
formulation.
Complete  Complete
manufacturing manufacturing
method method
including including
procedure of procedure of
outer core of outer core of
misoprostol, on misoprostol,
diclofenac on diclofenac
sodium tablet sodium tablet
before enteric before enteric
coating. coating.
659. -do- Dinec Tablet 75 mg Form 5 FDA approved Proof of Double Deferred for
Rs. 20,000/- Arthrotec – health punch  Confirmation
Each delayed release 08-06-2016) care UK. compression by FID for
tablet contains: Dy. No. 2455 machine. Double punch
Diclofenac sodium Erwin –Sami compression
50mg Pack of Complete machine.
Misoprostol 200mcg 10’s/as per DPC description of  Complete
20’s / as per DPC dosage form description of
(Regal Spec) required. dosage form
Pain reliever required.
Firm needs to  Firm needs to
follow innovator follow
brand innovator
formulation. brand
formulation.
Complete  Complete
manufacturing manufacturing
method method
including including
procedure of procedure of
outer core of outer core of
misoprostol, on misoprostol,
diclofenac on diclofenac
sodium tablet sodium tablet
before enteric before enteric
coating. coating.

660. -do- Pesom Tablet 50 mg Form 5 Myonal – Eisai Approved
Rs. 20,000/-
Each sugar coated 08-06-2016) Qulax – Myonal
tablet contains: Dy. No. 2449
Eperisone Hcl 50mg
Pack of
(Regal Spec) 10’s/as per DPC
Anticholinergic 20’s / as per DPC
30’s / as per DPC
661. -do- Epiwell CR Tablet Form 5 USFDA Depakote Deferred as more

250 Rs. 20,000/- than 10 molecules
08-06-2016 Local
Each Controlled Dy. No. 2473 Tablet Leptil at
release tablet 250 mg by
contains: Pack of 10’s/as Donvalley
Divalproex sodium per DPC pharmaceuticals
250mg 30’s / as per DPC
100’s / as per
(USP Spec) DPC
Antiepileptic
662. Regal Epiwell CR Tablet Form 5 USFDA Depakote Deferred as more

Pharmaceuticals, 500 Rs. 20,000/- than 10 molecules
Plot # 2-A, Street 08-06-2016 Local
# S-5 National Each Controlled Dy. No. 2465 Tablet Leptil at
industrial zone release tablet 250 mg by
Rawat- contains: Pack of 10’s/as Donvalley
Islamabad Divalproex sodium per DPC pharmaceuticals
DML of firm 100’s / as per
approved in 247st (USP Spec) DPC
meeting of Antiepileptic
Central
Licensing Board
held on 29-04-
2016.
663. -do- Radol-P Tablet Form 5 MHRA Approved
325/37.5 mg Rs. 20,000/- Tablet Tramacet
Each Film coated 08-06-2016 325/37.5mg
tablet contains: Dy. No. 2453 manufactured by
Paracetamol Grunenthal
325mg Pack of 10’s/as
Tramadol 37.5mg per DPC Local
(Regal Spec) 20’s / as per DPC Tablet Tronoflex P
Opiod analgesic 100’s / as per 325/37.5 mg
DPC by
Sami pharma
664. -do- Zolid Tablet 600 mg Form 5 MHRA Approved

Rs. 20,000/- Tablet Zyvox
Each Film coated 08-06-2016 600mg
tablet contains: Dy. No. 2450 manufactured by
Linezolid 600mg 340fizer

(Regal Spec) Pack of Local
Oxazolidone 10’s/as per DPC Tablet Nezolide
Antibiotic 20’s / as per DPC 600 mg
100’s / as per by
DPC Searl pharma
665. -do- Solfine Tablet 5 mg Form 5 MHRA Approved

Rs. 20,000/- Vesicare –Astellas
Each Film coated 08-06-2016 UK
Solifenacin succinate Fenaso – Highnoon
5mg Pack of
10’s/as per DPC
(Regal Spec) 20’s / as per DPC
Antimuscarinic
666. -do- Solfine Tablet Form 5 MHRA Approved

10 mg Rs. 20,000/- Vesicare Astellas
Each Film coated 08-06-2016
tablet contains: Dy. No. 2469 Tablet Vezitic
Solofinacin succinate 5mg
5mg Pack of 10’s/as By CCL
per DPC
(Regal Spec) 20’s / as per DPC
Antimuscarinic
667. Regal Qupixan Tablet 25 Form 5 MHRA Approved
Pharmaceuticals, mg Rs. 20,000/- Quetapine –
Plot # 2-A, Street 08-06-2016 Sandoze UK
# S-5 National Each Film coated Dy. No. 2457
industrial zone tablet contains:
Rawat- Quetapine 25mg Pack of Q-Par – Helix
Islamabad as Quetapine 10’s/as per DPC
Fumarate 20’s / as per DPC
approved in 247st (USP Spec)
meeting of Dibenzothiazepine
Central
Licensing Board
held on 29-04-
2016.
668. -do- Qupixan Tablet 50 Form 5 MHRA Approved
mg Rs. 20,000/- Quetapine –
08-06-2016) Sandoze UK
Each Film coated Dy. No. 2472
tablet contains:
Quetapine 50mg as Pack of 10’s/as Q-Par – Helix
Quetapine Fumarate per DPC
20’s / as per DPC
Dibenzothiazepine
669. -do- Qupixan Tablet 100 Form 5 MHRA Approved
mg Rs. 20,000/- Quetapine –
08-06-2016 Sandoze UK
tablet contains:

Quetapine 100mg as Pack of 10’s/as Q-Par – Helix
Quetapine Fumarate per DPC
20’s / as per DPC
Dibenzothiazepine
670. -do- Brudex Tablet 400 Form 5 Seractil (Genus Deferred as more
mg Rs. 20,000/- Pharmaceuticals than 10 molecules
08-06-2016 UK) BNF-67
tablet contains: Dexib –Tabros
Dexibuprofen Pack of 10’s/as
400mg per DPC
50’s / as per DPC
(Manufacture Spec)
Propionic acid
671. Regal Re-SPA Tablet Form 5 NO-SPA FORTE Deferred as more

Pharmaceuticals, 80 mg Rs. 20,000/- than 10 molecules
Plot # 2-A, Street 08-06-2016 Himont
# S-5 National Each Film coated Dy. No. 2468
industrial zone tablet contains:
Rawat- Drotaverine 80mg Pack of 10’s/as
Islamabad as Drotaverine Hcl per DPC
50’s / as per DPC
DML of firm (Regal Spec)
approved in 247st
meeting of Anti-Spasmodic
Central
Licensing Board
held on 29-04-
2016.
672. -do- Repram Tablet 10 mg Form 5 MHRA Approved
Rs. 20,000/- Cipralex
Each Film coated 08-06-2016 Lundback
Escitalopram 10mg Product of
as Escitalopram Pack of 10’s/as NabiQasim pharma
Oxalate per DPC
14’s / as per DPC
Anti depressant
673. Repram Tablet 20 mg Form 5 MHRA Approved
Rs. 20,000/- Cipralex
Each Film coated 08-06-2016 Lundback
Escitalopram 20mg Product of
as Escitalopram Pack of 10’s/as NabiQasim pharma
Oxalate per DPC
14’s / as per DPC
Anti depressant

674. -do- O-Mox Tablet 400 Form 5 MHRA Avelox Deferred as more
mg Rs. 20,000/- Bayer than 10 molecules
08-06-2016)
Each Film coated Dy. No. 2463 Moxiget – Getz
tablet contains:
Moxifloxacin 400mg Pack of 5’s/as per
as Moxifloxacin Hcl DPC
(Regal Spec)
FlouroQuinolone
Antibiotic
675. M/s Regal Mograll Fort Tablet Form 5 Approved status in Deferred as more
Pharmaceuticals, Rs. 20,000/- Pakistan reference than 10 molecules
Plot # 2-A, Street Each Film coated 08-06-2016 countries not
# S-5 National tablet contains: Dy. No. 2471 approved
industrial zone Orphenadrine Citrate
Rawat- 50mg + Paracetamol Pack of 30’s/as Local
Islamabad 450mg+ Caffeine per DPC Tablet Medigesic
30mg 50’s/as per DPC Fort
DML of firm By
approved in 247th (Regal Spec) 100’s/as per DPC Wilshire pharma
meeting of
Central Analgesic / Central
Licensing Board anti cholinergic /
held on 29-04- Xanthine
2016.
676. -do- Rostin Tablet 5mg Form 5 MHRA Approved
Rs. 20,000/- Crestor 5mg
Each Film coated 08-06-2016 Astrazeneca UK
Rosuvastatin 5mg Local
as Rosuvastatin Pack of Tablet Loster
Calcium 10’s/as per DPC By
20’s/as per DPC Helix pharma
(Regal Spec)
Lipid regulating
agent
677. Rostin Tablet 10mg Form 5 MHRA Approved
Rs. 20,000/- Crestor
Each Film coated 08-06-2016 Astrazeneca UK
Rosuvastatin 10mg Local
as Rosuvastatin Pack of 10’s/as Tablet Loster
Calcium per DPC By
Helix pharma
(Regal Spec) 20’s/as per DPC
Lipid regulating
agent
CAPSULE (GENERAL)
678. Regal Resold Capsule Form 5 MHRA approved Approved
Pharmaceuticals, 20mg Rs. 50,000/- Emozul
Plot # 2-A, Street 08-06-2016
# S-5 National Each Capsule Dy. No. 2493 Esso – Shaigan
industrial zone contains:
Rawat- Enteric coated pallets Pack of

Islamabad of Esomeprazole 10’s/as per DPC
20mg 14’s/as per DPC
DML of firm as Esomeprazole
approved in 247st magnesium
meeting of 344olymalto
Central
Licensing Board (USP Spec)
held on 29-04- Proton Pump
2016. Inhibitor
Source of
Esomeprazole Mg
ECP pellets 22.5%:-
M/s Vision
Pharmaceuticals, Plot
# 22-23, Industrial
Triangle, Kahuta
Road, Islamabad.
679. M/s Regal Resold Capsule Form 5 MHRA Approved

Pharmaceuticals, 40mg Rs. 50,000/- Emozul
Plot # 2-A, Street 08-06-2016
# S-5 National Each Capsule Dy. No. 2496 Esso – Shaigan
Rawat- Enteric coated pallets Pack of 10’s/as
Islamabad of Esomeprazole per DPC
40mg
DML of firm as Esomeprazole
approved in 247st magnesium dehydrate
meeting of
Central (USP Spec)
Licensing Board Protin pump Inhibitor
held on 29-04-
2016. Source of
Esomeprazole Mg
ECP pellets 22.5%:-
M/s Vision
# 22-23, Industrial
Triangle, Kahuta
Road, Islamabad.
680. Thicosid 4mg Form 5 Muscoril – Sanofi, Approved

Capsule Rs. 20,000/- France
08-06-2016
Each Capsule Dy. No. 2491 Muscoril –Searle
contains:
Thiocolchicoside Pack of
14’s/as per DPC
(Regal Spec)
Skeletal muscle
relaxant
681. Regastat 120mg Form 5 FDA approved Approved
Capsule Rs. 50,000/- Xenical
08-06-2016)

Each Capsule Dy. No. 2513 Alli 120mg
contains immediate GSK consumer
release pallets of Pack of 20’s / health care USA
Olrlistat 120mg as per DPC
Local
(USP Spec) Capsule Febical
Lipase inhibitor By
Highnoon
Source of Orlistat Laboratories
IR pellets 50%:-
M/s Vision
# 22-23, Industrial
Triangle, Kahuta
Road, Islamabad.
682. -do- Regalin 50mg Form 5 FDA approved Approved

Capsule Rs. 20,000/- Lyrica Pfizer
08-06-2016
Each Capsule Dy. No. 2506 Gabalin - CCL
contains:
Pregabalin 50mg Pack of 14’s /
as per DPC
(Regal Spec)
GABA Analogue

08-06-2016)
contains:
as per DPC
(Regal Spec)
GABA Analogue

08-06-2016
contains:
as per DPC
(Regal Spec)
GABA Analogue
685. -do- Olanzin – F 3/25mg Form 5 USFDA SYMBAX Approved

Capsule Rs. 20,000/-
08-06-2016) Co-Depricap,
Each Capsule Dy. No. 2497 NabiQasim
contains:
Olanzapine 3mg Pack of
Fluoxetine 25mg 14’s / as per DPC
30’s / as per DPC
(USP Spec)

Thienobenzodiazepin
e /SSRI
686. -do- Capsule Olanzin – F Form 5 USFDA SYMBAX Approved

6/25 Rs. 20,000/-
08-06-2016 Co-Depricap,
contains:
Olanzapine 6mg Pack of 14’s /
Fluoxetine 25mg as per DPC
(USP Spec)
Thienobenzodiazepin
e /SSRI
687. Olanzin – F 12/25mg Form 5 USFDA SYMBAX Me too needs Approved
Capsule Rs. 20,000/- confirmation
08-06-2016 Co-Depricap,
contains:
Olanzapine 12mg Pack of 14’s /
Fluoxetine 25mg as per DPC
(USP Spec)
Thienobenzodiazepin
e /SSRI
688. M/s Regal Recoxib 200mg Form 5 MHRA approved Approved

Pharmaceuticals, Capsule Rs. 20,000/- Celebrex – Pfizer
Plot # 2-A, Street 08-06-2016
# S-5 National Dy. No. 2502 Artiflex –
industrial zone Each Capsule Standpharm
Rawat- contains: Pack of 10’s /
Islamabad Celecoxib 200mg as per DPC
20’s / as per DPC
approved in 247st (Regal Spec)
meeting of COX -2 Inhibitor
Central
Licensing Board
held on 29-04-
2016.
689. Regal Tamsuger 0.4mg Form 5 FDA approved Approved

Pharmaceuticals, Capsule Rs. 50,000/- Contiflo XL
Plot # 2-A, Street 08-06-2016 E.Lilly and
# S-5 National Each Capsule Dy. No. 2494 company
Rawat- Tamsulosin HCl SR Pack of 10’s / Local
Islamabad pellets 0.2% eq to as per DPC Capsule Proset
Tamsulosin 0.4mg 20’s / as per DPC By
Synchro pharma
(USP Spec)
Slective alpha-1
blocker
Source of pellets :-

M/s Vision
Pharmaceutcals ,
Kahuta rOad,
Islamabad.
690. -do- Venflax XR 37.5mg Form 5 Proof of Deferred for
Capsule Rs. 50,000/- approval status confirmation of
Each Capsule 08-06-2016 of same dosage approval status of
contains: Dy. No. 2595 form in formulation by
Extended release reference reference regulatory
pallets of Pack of 10’s / countires and authorities and
Vanlafaxine 37.5mg as per DPC Pkaistan not Pakistan.
as Vanlafaxine Hcl provided.
14’s / as per DPC
(USP Spec)
Serotonin &
noradrenaline
reuptake inhibitor
Source of Venlafaxine
HCl SR pellets 33% :-
M/s Vision
Pharmaceuticals, Plot #
22-23, Industrial
Triangle, Kahuta Road,
Islamabad.
691. -do- Venflax XR 75mg Form 5 FDA approved Approved

Capsule Rs. 50,000/- Efexor XL
08-06-2016) Pfizer Ltd
Each Capsule Dy. No. 2492 USA
contains:
Extended release Pack of 10’s /
pallets of as per DPC Venalax – Stand
Vanlafaxine 75mg as pharm
Vanlafaxine Hcl 14’s / as per DPC
(USP Spec)
Serotonin &
noradrenaline
reuptake inhibitor
Source of Venlafaxine
HCl SR pellets 33% :-
M/s Vision
Pharmaceuticals, Plot #
22-23, Industrial
Triangle, Kahuta Road,
Islamabad.
692. M/s Regal Erox 60mg Capsule Form 5 The proposed Rejected as
Pharmaceuticals, Rs. 20,000/- formulation is in proposed
Plot # 2-A, Street Each Capsule 08-06-2016 tablet form in formulation is
# S-5 National contains: Dy. No. 2499 reference approved in tablet
industrial zone Etroricoxib 60mg countries and dosage form by
Rawat- Pack of 10’s / not in capsule reference regulatory
Islamabad (Regal Spec) as per DPC form. authorities

Cyclooxygenase
inhibitor 20’s / as per DPC
693. -do- Rethro 250mg Form 5 FDA approved Approved

Capsule Rs. 20,000/- Azisara 250mg
08-06-2016 Piramal healthcare
Each Capsule Dy. No. 2487
contains: Local
Azithoromycin Pack of 6’s / Capsule Bactizith
250mg as as per DPC 250mg
Azithromycin By
dehydrate 10’s / as per DPC Woodwards
(USP Spec)
Macrolide antibiotic
694. -do- Mervin- MR 200mg Form 5 MHRA Innovator brand Deferred for
Capsule Rs. 50,000/- Clofac MR contains confirmation
(21-06-2016) BGP Ltd modified release whether granules of
Each Capsule Dy. No. 2464 UK granules. M/s Vision Pharma
contains: are modified release
Mebeverine HCl SR Pack of 10’s / Local or otherwise
pellets 50% eq to as per DPC Capsule
Mebeverine Hcl 20’s / as per DPC Mebeverine MR
200mg 30’s / as per DPC By
Getz pharma
(Regal Spec)
Antispasmodic
Source of pellets:-
M/s Vision
Pharmaceuticals,
Kahuta Road,
Ilsambad.
ORAL DRY POWDER (GENERAL)
695. M/s Regal Rethrocin 125mg Form 5 FDA approved The innovator Approved
Pharmaceuticals, /5ml Rs. 20,000/- Claricid brand is in
Plot # 2-A, Street oral drops 08-06-2016) 125mg/5ml granules
# S-5 National Dy. No. 2528 Abbott laboratories formulation.
industrial zone Each 5ml of
Rawat- reconstituted Pack of 60ml / Local
Islamabad suspension contains: as per DPC Claritek
Clarithromycin 125mg/5ml
27.5% EC Taste By
Masked pellets eq to Getz pharma
Clarithromycin
125mg
(USP Spec)

M/s Vision
Pharmaceuticals,
Kahuta rOad,
Islamabad.
696. Regal Rethrocin 250mg Form 5 FDA approved The innovator Approved
Pharmaceuticals, /5ml Rs. 20,000/- Claricid brand is in
Plot # 2-A, Street oral suspension 08-06-2016 250mg/5ml granules
# S-5 National Dy. No. 2530 Abbott laboratories formulation.
industrial zone Each 5ml of
Rawat- reconstituted Pack of 60ml / Local
Islamabad suspension contains: as per DPC Claritek
Clarithromycin 250mg/5ml
DML of firm 27.5% EC Taste By
approved in 247st Masked pellets eq to Getz pharma
meeting of Clarithromycin
Central 250mg
Licensing Board
held on 29-04- (USP Spec)
2016. Macrolide antibiotic
M/s Vision
Pharmaceuticals,
Kahuta rOad,
Islamabad.
697. -do- Azocine 200mg /5ml Form 5 MHRA approved Approved

oral Dry Suspension Rs. 20,000/- brand of 349andoz
08-06-2016)
Each 5ml Dy. No. 2524 Local
(reconstituted) Zithrosan
contains: Pack of 30ml / 200mg/5ml
Azithromycin as per DPC By
200mg Sante pharma
15ml /
(USP Spec) as per DPC
698. -do- Remal 15/90mg /5ml Form 5 WHO Approved
oral Dry suspension Rs. 20,000/- recommended
08-06-2016) formulation
Each 5ml Dy. No. 2525
(reconstituted) Artem – Hilton
contains: Pack of 30ml /
Artimether 15mg as per DPC
Lumefantrine 90mg.
60ml /
(Manufacture Spec) as per DPC
Anti-malarial
699. -do- Remal 20/120mg Form 5 Proof provided Rejected as
/5ml Rs. 20,000/- by firm for proposed
oral D/S 08-06-2016) proposed formulation is
Dy. No. 2531 Local formulation neither approved by
Each 5ml Arceva availability in reference regulatory

(reconstituted) Pack of 30ml / 20/120mg/5ml reference authorities nor
contains: as per DPC By countires and recommended by
Artimether 20mg Sami Pakistan is not WHO.
Lumefantrine 60ml / pharmaceuticals correct.
120mg. as per DPC
(Manufacture Spec)
Anti-malarial
700. Regal Zolid 100mg /5ml Form 5 FDA approved Approved with
Pharmaceuticals, oral D/S Rs. 20,000/- 100mg/5ml change of brand
Plot # 2-A, Street 08-06-2016 name.
# S-5 National Each 5ml Dy. No. 2490 Local
industrial zone (reconstituted) Nezilide
Rawat- contains: Pack of 60ml / 100mg/5ml
Islamabad Linzolide 100mg as per DPC By
Powder for Searle
DML of firm suspension pharmaceuticals
approved in 247st
meeting of (Regal Spec)
Central Antibiotic
Licensing Board
held on 29-04-
2016.
701. -do- Zincal 10mg /5ml Form 5 The proposed Deferred for
oral D/S Rs. 20,000/- formulation in confirmation of
08-06-2016) Local dry powder approval status by
Each 5ml contains: Dy. No. 2527 Rite-Zinc forms while reference regulatory
Zinc Sulphate 10mg. 10mg/5ml WHO authorities or WHO
Pack of 60ml / By recommended in dry powder
(Regal Spec) as per DPC Fynk formulation is suspension.
Zinc Supplement pharmaceuticals oral solution.
702. R – Flucon 50mg Form 5 MHRA Approved with

/5ml Rs. 20,000/- DiFlucan one change of brand
oral D/S 08-06-2016) 50mg/5ml name
Dy. No. 2526 Jhonson & Jhonson
Each 5ml contains: Newsland
Fluconazole 50mg Pack of 35ml /
as per DPC Local
(Regal Spec) Zolanix
By
Anti-Fungal GSK
pharmaceuticals
703. -do- Re – Dos 175mg Form 5 The product is Deferred for
/5ml Rs. 20,000/- Local not available in confirmation of
oral Dry suspension 08-06-2016) Dostin the proposed approval status of
Dy. No. 2785 By formulation in formulation by
Each 5ml of Brooks reference reference regulatory
reconstituted Pack of 35ml / pharmaceuticals countires. authorities and
suspension contains: as per DPC Pakistan.
Erdosterine 175mg
(Regal Spec)

Mucolytic agent
704. Regal Resar 100mcg /5ml Form 5 MHRA Firm doesn’t Deferred for
Pharmaceuticals, oral D/S Rs. 20,000/- Foradil possess confirmation of
Plot # 2-A, Street 08-06-2016 Novartis Uk Ltd segregated approval status of
# S-5 National Each 5ml contains: Dy. No. 2787 UK licensed formulation by
industrial zone Formoterol fumarate manufacturing reference regulatory
Rawat- 100mcg Pack of 60ml / Local facility for authorities and
Islamabad as per DPC Easair Capsule Pakistan in dry
(Regal Spec) By (Steroid) powder suspension.
DML of firm Platinum Moreover status of
approved in 247st Mucolytic pharmaceuticals product will also be
meeting of verified as steroid
Central or otherwise
Licensing Board
held on 29-04-
2016.
705. -do- Re-Zox 100mg /5ml Form 5 FDA approved Approved
oral D/S Rs. 20,000/- Alinia
08-06-2016 Lupin pharma
Each 5ml contains: Dy. No. 2786 USA
Nitazoxanide 100mg
Pack of 60ml / Local
(Regal Spec) as per DPC Izato
By
Nitrothiazolyl- Sami
salicylamide prodrug pharmaceuticals
706. -do- Regsan Form 5 Reference Deferred for
500mg /30ml Rs. 20,000/- Liviat –Siza countries confirmation of
oral D/S 08-06-2016 approval status approval status of
Dy. No. 2783 required formulation by
Each dose of 30ml reference regulatory
contains: Pack of 30ml / authorities and
Secnidazole 500mg as per DPC Pakistan.
(Regal Spec)
Nitoimidazole
707. -do- Regsan 750mg /30ml Form 5 Eknit – Hilton Reference Deferred for
oral Dry suspension Rs. 20,000/- countries confirmation of
08-06-2016 approval status approval status of
Each dose of 30ml Dy. No. 2784 required. formulation by
contains: reference regulatory
Secnidazole 750mg Pack of 30ml / authorities and
as per DPC Pakistan.
(Regal Spec)
Nitoimidazole
ORAL LIQUID SYRUP/SUSPENSION (GENERAL)

708. Regal Metrozole Plus Oral Form 5 The product not Deferred for
Pharmaceuticals, suspension Rs. 20,000/- Metrodil –Sharex dound in confirmation of
Plot # 2-A, Street 08-06-2016) reference approval status of
# S-5 National Each 5ml contains: Dy. No. 2518 countires. formulation by

industrial zone Metronidazole as reference regulatory
Rawat- Benzoate 200mg Pack of 90ml / authorities and
Islamabad Diloxanide furoate as per DPC Pakistan.
250mg
DML of firm
approved in 247st (Regal Spec)
meeting of Nitoimidazole ,
Central Amoebicide
Licensing Board
held on 29-04-
2016.
709. -do- Metrozole Oral Form 5 MHRA Approved
Liquid suspension Rs. 20,000/- Flygl, Sanofi-
08-06-2016 Aventis UK
Each 5ml contains: Dy. No. 2522
Metronidazole (as
Benzoate) 200mg Pack of Flgyl Sanofi-
60ml /as per DPC Aventis
(BP Spec) 120ml /as per
Nitoimidazole DPC
450ml / as per
DPC
710. -do- Dom – V Oral Liquid Form 5 MHRA-UK Approved

suspension Rs. 20,000/- Approved product
08-06-2016)
Domperidone Motillium – J & J
Maleate 5mg Pack of
60ml / as per DPC
(Regal Spec) 120ml / as per DPC
Anti-dopaminergic
711. -do- Sucralate Oral Liquid Form 5 MHRA Approved

suspension Rs. 20,000/- Antepsin 1gm
08-06-2016) Merk Barcelona
Each 5ml contains: Dy. No. 2519 spain
Sucralfate 1gm
Pack of
(Regal Spec) 60ml / as per DPC Ulsonic –
Anti-ulcerant/ 120ml /as per DPC Highnoon
mucoprotactant
712. M/s Regal Brofenac Oral liquid Form 5 MHRA approved Approved
Pharmaceuticals, suspension Rs. 20,000/- brand UK
Plot # 2-A, Street 08-06-2016)
# S-5 National Each 5ml contains: Dy. No. 2521
industrial zone Ibuprofen 100mg Brufen – Abbott
Rawat- Pack of 90ml /
Islamabad (USP Spec) as per DPC
Analgesic /
DML of firm Antipyretic
approved in 247st
meeting of
Central

Licensing Board
held on 29-04-
2016.
713. -do- Brofenac DS Form 5 MHRA approved Approved
Oral liquid Rs. 20,000/- brand UK
suspension 08-06-2016
Ibuprofen 200mg Brufen – Abbott
Pack of 90ml /
Analgesic /
Antipyretic
714. -do- Levocine oral Form 5 FDA approved Approved
solution Rs. 20,000/- Xyzal oral solution
08-06-2016 UCB pharma
Each 5ml contains: Dy. No. 2477 USA
Levocetirizine as di-
hydro chloride 2.5mg Pack of 60ml / Local
as per DPC Ocitra
(Regal Spec) By
Searle laboratories
Anti-Histamine
715. -do- Epiwell 250mg Form 5 Reference Deferred for

Oral Liquid syrup’ Rs. 20,000/- countires and confirmation of
08-06-2016) Pakistan approval status of
Each 5ml contains: approval status formulation by
Sodium valproate Dy. No. 2516 not given. reference regulatory
250mg authorities and
Pack of 60ml / Pakistan.
Anti-Epileptic
716. -do- Epiwell 500mg Form 5 Reference Deferred for

Oral Liquid syrup Rs. 20,000/- countires and confirmation of
08-06-2016 Pakistan approval status of
Each 5ml contains: Dy. No. 2512 approval status formulation by
Divalproex 500mg not given. reference regulatory
(USP Spec) Pack of 60ml / authorities and
Anti-Epileptic as per DPC Pakistan.
717. -do- Regadryl Oral Liquid Form 5 Approved status in Deferred for
syrup Rs. 20,000/- Pakistan, reference confirmation of
08-06-2016) from other approval status of
Each 5ml contains: Dy. No. 2523 counteriesd not formulation by
Amiophylline 32mg available reference regulatory
Diphanhydramin Pack of 120ml / authorities.
8mg. as per DPC
Ammonium chloride Local
30mg Hydralline
Menthol 0.98mg By
Searle pharma
(Regal Spec)
Anti-
Histamine/Xanthine/
Expectorant.

718. -do- Regtus Oral Liquid Form 5 Approved status in Deferred for
suspension Rs. 20,000/- Pakistan, reference confirmation of
08-06-20162478 from other approval status of
Each 5ml contains: Dy. No. counteries not formulation by
Paracetamol 80mg available reference regulatory
Pseudoephiderine Hcl Pack of 120ml / authorities.
15mg. as per DPC
Chlorphenaramine Local
maleate 1mg Reltus CF
By
(Regal Spec) Pharmatec
Anti-Tussive /
Antipyretic
719. M/s Regal Regofer – F Oral Form 5 Approved status in Approved
Pharmaceuticals, Liquid Rs. 20,000/- Pakistan, reference
Plot # 2-A, Street 08-06-2016 from other
# S-5 National Dy. No. 2511 counteries not
industrial zone Each 5ml contains: available
Rawat- Pack of 120ml /
Islamabad Iron Ш hydroxide as per DPC
354olymaltose Local
DML of firm complex eq. To Approved vide
approved in 247st elemental Iron 50mg registration
meeting of No.055272
Central Folic Acid 0.35mg Rubifer-F- AGP
Licensing Board
held on 29-04- (Regal Spec)
2016. Haematinic .
720. -do- Regacal Oral Liquid Form 5 MHRA Approved

suspension Rs. 20,000/- Almus Paracetamol
08-06-2016) BCM. Nottingham
Each 5ml oral Dy. No. 2520 UK
suspension contains:
Paracetamol 120mg Pack of 120ml / Local
as per DPC Calpol
(BP Spec) By
Anti-pyretic GSK
LIQUID VIAL INJECTION (GENERAL)

721. -do- Ciprocin Infusion Form 5 FDA approved Approved
Rs. 20,000/- Cipro
Each 100ml contains: 08-06-2016 Bayer corporation
Ciprofloxacin as Dy. No. 2474 pharmaceutical
lactate 200mg division USA
Pack of 100ml /
(USP Spec) as per DPC Local
Novidate
Quinolone Antibiotic By
Sami
pharmaceutical
722. -do- Ciprocin Form 5 Qilox –Bosch Reference Deferred for

Liquid vial injection Rs. 20,000/- countires confirmation of
(Infusion) 08-06-2016 approval status approval status of

Dy. No. 2475 required for formulation by
Each 100ml contains: proposed dosage reference regulatory
Ciprofloxacin as Pack of 100ml / form. authorities.
lactate 400mg as per DPC
(USP Spec)
Quinolone Antibiotic
723. -do- Metrozole Infusion Form 5 MHRA approved Approved

Rs. 20,000/- brand of Baxter
Each 100ml contains: 08-06-2016
Metronidazole Dy. No. 2481 Flagyl –Sanofi
500mg
Pack of 100ml /
Nitroimidazole / Anti
protozoal
724. -do- O – Mox Infusion Form 5 FDA approved Approved

Rs. 20,000/- Avelox –Bayer \
Each 250ml contains: 08-06-2016)
Moxifloxacin (as Dy. No. 2484 Moxiget – Getz
HCl) 400 mg
Pack of 250ml /
(Regal Spec) as per DPC
Quinolone Antibiotic
725. -do- WEFLOX Infusion Form 5 MHRA Evoxil – Approved

Rs. 20,000/- Beacon
Each 100 ml 08-06-2016
contains: Dy. No. 2476
Levofloxacin 500 mg Leflox – Getzs
(5mg/ml) Pack of 100ml /
as per DPC
(Regal Spec)
Floro Quinolone
Antibiotic
726. -do- Zolid Infusion 200mg Form 5 FDA approved Approved with
Rs. 20,000/- Zyvox change of brand
Each 100ml contains: 08-06-2016 Pharmacia Upjohn name
Linzolid 200mg Dy. No. 2479 pharmaceutical
Newyork
(Regal Spec) Pack of 1200ml / USA
as per DPC
Oxazolidinone Local
Antibacterial Ecasil
By
Sami
Newyork

as per DPC
Oxazolidinone Local
By
Sami
Newyork
as per DPC
Oxazolidinone Local
By
Sami
729. -do- PARAMOL Infusion Form 5 MHRA approved Approved with

Rs. 20,000/- product of Actavis change of brand
Each 100ml contains: 08-06-2016 name
Paracetamol 1gm Dy. No. 2480 Provas - Sami
(USP Spec) Pack of 300ml /

Antipyretic as per DPC
730. -do- Amikan Liquid Form 5 FDA amikasin- Proof of Deferred for proof
injection Rs. 20,000/- Teva 250mg/ml approval of of approval of same
08-06-2016) same dosage formulation
Each 2ml vial Dy. No. 2505 Srasil – Sami form in strength (250mg/2ml) by
contains: 250mg/2ml in reference regulatory
Amikacin (as Pack of 2ml / reference authorities.
Sulphate) 250mg as per DPC countires is not
correct.
(BP Spec)
Aminoglycoside
Antibacterial
731. -do- Amikan injection Form 5 FDA approved Approved with

500mg Rs. 20,000/- Amikasin Teva change of brand
08-06-2016) name
Amikacin (as Srasil
Sulphate) 500mg Pack of 2ml / By
as per DPC Sami
(BP Spec)
Aminoglycoside
Antibacterial
LIQUID AMPOULE INJECTABLE (GENERAL)
732. -do- V-REN Liquid Form 5 FDA approved Approved

injection Rs. 20,000/- Dyloject –
08-06-2016) Hospira
Each 3ml ampoule Dy. No. 2508

Contains: Dyclo – Indus
Diclofenac sodium Pack of 3ml /
75mg as per DPC
(Regal Spec)
NSAID
733. -do- Ondis injection Form 5 MHRA Approved
Rs. 20,000/- Ondansteron
Each 4ml Ampoule 08-06-2016 USA
Contains: Dy. No. 2510
Ondansetron 8mg Local
Pack of 5 x 4ml / Onset injection
(USP Spec) as per DPC By
Anti-emetic (5HT3 Pharmedic
antagonist) laboratories
734. -do- Ibro injection 3ml Form 5 FDA approved Approved

Rs. 20,000/- Ibandronate
Each 3ml ampoule 08-06-2016 Sodium Injection
contains Dy. No. 2504 vial - Sun
Ibandronate Pharmaceutical
monosodium Pack of 3ml / India
monohydrate salt BP as per DPC
eq to ibandronic acid Bonviva – Roche
3mg
Biophosphonate
Specification:-
Manufacture
735. -do- Calcirol injection Form 5 FDA approved Approved

Rs. 20,000/- Calitriol
Each 1ml Ampoule 08-06-2016) Americal Regent
Contains: Dy. No. 2500 pharmaceutical
Calcitriol 1mcg USA
Pack of 10 x 1ml /
(USP Spec) as per DPC Local
Vitamin D Analogue Calciwins injection
By
Winsfield pharma
736. -do- Calcvit injection Form 5 Vit D3 B.O.N, Approved

Rs. 20,000/- France
Each 1ml Ampoule 08-06-2016
Cholicalciferol 5mg Indrop D – Neutro
Pack of 1X1ml /
Vitamin D Analogue
737. Re-lac injection Form 5 USFDA Toradol – Approved

Rs. 20,000/- Roche
08-06-2016
Each 1ml Ampoule Dy. No. 2485
Contains: Molac – Linear

Ketorolac Pack of 5 x 1ml /
Trometamol 30mg as per DPC
(USP Spec)
NSAID
738. -do- Iron-C injection Form 5 FDA approved Approved

Rs. 20,000/- Venofer
Each 5ml Ampoule 08-06-2016) 100mg/5ml
Contains: Dy. No. 2503 Ampoule
Iron sucrose complex
equivalent to Pack of 5X5ml / Local
elemental iron 100mg as per DPC Bislery-S injection
By
(USP Spec) Sami pharma
Hematinic
739. -do- Regamin injection Form 5 Methycobal – Approved
Rs. 20,000/- Eisai, Japan
Each 1ml amber glass 08-06-2016
ampoule Contains: Dy. No. 2507 Mabil – Sami
Mecobalamin
500mcg Pack of 10 x 1ml /
as per DPC
(Regal Spec)
Vitamin B12 co-
enzyme
740. -do- Regadol injection Form 5 MHRA Tramol – Approved
Rs. 20,000/- CSL
Each 2ml Ampoule 08-06-2016)
Tramadol Hcl 100mg Lamadol – Brooks
Pack of10X1ml / pharma
Opiate Analogue
741. -do- Remol injection Form 5 Proof of Deferred for

Rs. 20,000/- Paygone approval status confirmation of
Each 2ml Ampoule 08-06-2016 injection of same dosage approval status of
Contains: Dy. No. 2501 By form in formulation by
Paracetamol 300mg Fynk reference reference regulatory
Lidocain Hcl 20mg Pack of10X1ml / pharmaceuticals countires not authorities.
as per DPC provided.
(Regal Spec)
NSAID / Local
anesthetic
742. -do- AQUA-R Form 5 FDA approved Approved

Liquid Ampoule Rs. 20,000/- Sterile water for
injection 08-06-2016 injection
5ml Ampolue Dy. No. 2788 Americal Regent
pharmaceutical
Each 5ml Ampoule Pack of USA
Contains: 100 X5ml / as per
Sterile water for DPC Local
injection Aqua -P injection
By

(BP Spec) Ipram pharma
Vehicle/solvent/Dilue
nt for parental
administration
New Veterinary Licensed Unit M/s Vantage Pharmaceutical, 54/ R.B SARHALI, 6-KM
SANGLA HILL ROAD SHAHKOT, FAISALABAD.
S/N Name and Brand Name Type of Form International Remarks Decision
address of (Proprietary name + Initial date, diary status in
manufacture Dosage Form + Strength) Fee including reference drug
r / Applicant Composition differential fee agencies /
Pharmacological Group Demanded Price / authorities
Finished product Pack size Me-too status
Specification GMP status as
depicted in
latest
inspection
report (with
date) by the
Evaluator
Veterinary Oral Liquid (General)
743. M/s Vantage Bromodil oral Liquid Form 5 Doctyl Super Approved
Pharmaceuti Rs. 20,000/- Solution –
cal, 54/R.B Each 100 ml contains: 21-06-2016 Alina
Sarhali, 6- Tylosin Tartrate 10gm Dy. No. 254
km Sangla Doxycycline HCl 20gm DML of firm
Hill Road, Bromhexine 1gm approved in
Shahkot, Pack size 100ml, 247st meeting
Faisalabad. (Manufcature Specification) 500ml & one litre of Central
Antibiotics Licensing
Price decontrolled Board held on
29-04-2016.
744. -do- Micotil 250 oral liquid Form 5 Tilcosin 25% - Approved
Rs. 20,000/- Nawan
Each ml contains: 21-06-2016
Tilmicosin 250mg Dy. No. 258
(Manufcature Specification) Pack size 100ml,

Antibiotics 250ml, 500ml, one
litre & 5 litre
Price decontrolled
745. -do- ENROX TAGE 20% oral Form 5 ENROCK -IPL Approved
liquid Rs. 20,000/-
21-06-2016

Each ml contains: Dy. No. 259
Enrofloxacin 200 mg
Pack size 100ml,
(Manufcature Specification) 250ml, 500ml, one
Antibiotics litre & 5 litre
Price decontrolled
746. -do- FOXIN TAGE oral liquid Form 5 FLORICOL – Approved

Rs. 20,000/- DECENT
Each ml contains: 21-06-2016
Florfenicol 230mg Dy. No. 256
Colistin Sulphate 50 MIU
Pack size 100ml,
Price decontrolled
747. -do- TAGE TRIL 10% oral Form 5 FLORICOL – Approved

liquid Rs. 20,000/- DECENT
21-06-2016
Each 100 ml contains: Dy. No. 257
Enrofloxacin 10gm
(100 mg/ml) Pack size 100ml,
250ml, 500ml, one
(Manufcature Specification) litre & 5 litre
Antibiotics Price decontrolled
748. -do- SULFATRIN TAGE oral Form 5 TRISTAR - Approved
liquid Rs. 20,000/- BIOGEN
21-06-2016
Each ml contains: Dy. No. 262
Sulphadiazine 400mg
Trimethoprim 80 mg Pack size 100ml,
250ml, 500ml, one
(Manufcature Specification) litre & 5 litre
749. -do- TIVERDOX oral liquid Form 5 MEDIDOX - Approved
Rs. 20,000/- MEDIVET
Doxycyclin HCl 20gm Dy. No. 250
Tylosin Tartrate 10gm
Pack size 100ml,
Price decontrolled
750. -do- FLORFEN 23 oral liquid Form 5 BAFLOR 23 - Approved
Rs. 20,000/- BAARIQ
Florfenicol 23gm Dy. No. 251
(Manufcature Specification) Pack size 100ml,

Antibiotics 250ml, 500ml, one
litre & 5 litre
Price decontrolled
751. -do- MICROMUTIN oral liquid Form 5 Tylo biotech – Approved
Rs. 20,000/- grand

Tylosin Tartrate 10gm Dy. No. 251
Doxycycline HCl 20gm
Colistin Sulphate 50000 IU Pack size 100ml,
Bromhexine 0.5gm 250ml, 500ml, one
litre & 5 litre
(Manufcature Specification) Price decontrolled
Antibiotics
752. -do- EAFLEXIN TAGE oral Form 5 ENROCOL Approved
liquid Rs. 20,000/- 10% - LEADS
21-06-2016
Enrofloxacin 10gm
Colistin Sulphate Pack size 100ml,
50,000,000 IU 250ml, 500ml, one
litre & 5 litre
Antibiotics
Veterinary Oral Powder
753. M/s Vantage Vantage ESB 30% Oral Form 5 E-COX ORAL Approved
Pharmaceuti Powder Rs. 20,000/- POWDER -
cal, 54/R.B 21-06-2016 BIOGEN
Sarhali, 6- Each 100 gm contains: Dy. No. 266
km Sangla Sulphaclozine sodium DML of firm
Hill Road, monohydrate 30gm approved in
Shahkot, Pack size 100gm, 247st meeting
Faisalabad. (Manufcature Specification) 250gm, 500gm, of Central
Antibiotics 1kg & 5kg Licensing
Price decontrolled Board held on
29-04-2016.
754. -do- DOXY TAGE Oral Powder Form 5 DOXYTYL Approved

Rs. 20,000/- ORAL
Each 100 gm contains: 21-06-2016 POWDER -
Tylosin tartrate 10gm Dy. No. 261 NAWAL
Pack size 100gm,
(Manufcature Specification) 250gm, 500gm,
Antibiotics 1kg & 5kg
Price decontrolled
755. -do- COLI TAGE 48 Oral Form 5 Deferred for

Powder Rs. 20,000/- confirmation of
21-06-2016 approval status of
Each gm contains: Dy. No. 260 same formulation in
Colistin Sulphate 48000000 Pakistan.
IU Pack size 100gm,
250gm, 500gm,
(Manufcature Specification) 1kg & 5kg
756. -do- TYL-D600 Oral Powder Form 5 REOCIN TD - Approved

Rs. 20,000/- DELUX
Each 100 gm contains: 21-06-2016
Tylosin tartrate 20gm Dy. No. 263
Pack size 100gm,

(Manufcature Specification) 250gm, 500gm,
Antibiotics 1kg & 5kg
Price decontrolled
757. -do- OXYTAGE Oral Powder Form 5 NEOCHLOR - Approved

Rs. 20,000/- ALINA
Each 100 gm contains: 21-06-2016
Oxytetracycline HCl 25gm Dy. No. 263
Neomycin Sulphate 25gm
Colistin Sulphate 30 MIU Pack size 100gm,
250gm, 500gm,
758. -do- VANTAGE ASPER-C Oral Form 5 Approved

Powder Rs. 20,000/- SB – ASPER-
21-06-2016 SB PHARMA
Each 100 gm contains: Dy. No. 264
Vitamin C 20gm
Acetylsalicylic acid 6.7gm Pack size 100gm,
250gm, 500gm,
Vitamin / antipyretic / anti Price decontrolled
inflammatory
759. -do- SPECLIN TAGE Oral Form 5 The product in Deferred for
Powder Rs. 20,000/- proposed submission of
21-06-2016 strength is not registration
Each gm contains: Dy. No. 265 yet registered in application on
Lincomycin HCl 222mg Pakistan. prescribed Form 5-
Spectinomycin HCl 444 mg Pack size 100gm, D as product in
250gm, 500gm, proposed strength is
(Manufcature Specification) 1kg & 5kg not yet registered in
Antibiotics Price decontrolled Pakistan.
760. -do- TYLOSTIN Oral Powder Form 5 Bronchodil – The local Deferred for
Rs. 20,000/- Attabak availability is in submission of
Each 1000 gm contains: 21-06-2016 liquid form registration
Tylosin Tartrate 100gm Dy. No. 268 while firm has application on
Doxycyclin HCl 200gm applied for fwy prescribed Form 5-
Colistin Sulphate 480 MIU Pack size 100gm, powder. D as product in
Bromhexine HCl 3 gm 250gm, 500gm, proposed strength is
1kg & 5kg not yet registered in
(Manufcature Specification) Price decontrolled Pakistan.
Antibiotics Deferred for
confirmation of
approval status of
same formulation in
Pakistan and
reference regulatory
authorities as
already approved
formulation are in
liquid form while
firm has applied for
dry powder.

761. -do- CHLOR NEC Oral Powder Form 5 Approved
Rs. 20,000/- STRIKER -
Each 1000 gm contains: 21-06-2016 WIMITS
Chlortetracyclin 80gm Dy. No. 269
Neomycin Sulphate 70gm
Colistin Sulphate 4 gm Pack size 100gm,
250gm, 500gm,
762. -do- SPECLINX Oral Powder Form 5 Spiralin –B Approved

Rs. 20,000/- (Attabak)
Each 100 gm contains: 21-06-2016 import 249th
Lincomycin HCl 5gm Dy. No. 267 meeting and
Spectinomycin HCl 7.5gm 254th meeting
Spiramycin adipose 2.5gm Pack size 100gm,
Bromhexine HCl 0.5 gm 250gm, 500gm,
1kg & 5kg
Antibiotics

New Section:-
address of status in Observation
manufacturer (Proprietary name + Initial date, diary stringent s
Dosage Form + regulatory
/ Applicant Fee including
Strength) agencies
differential fee
Demanded Price /
Pharmacological Pack size GMP status as
Group depicted in
inspection report
Finished product (dated)
Specification
Following cases of Azilsartan containing formulations were deferred in 259th meeting of the
board:
Decision (259th meeting): Registration Board noticed that significant changes in the assay of the
API have been occurred in Azilsartan formulations applied by different applicants.
Therefore, all cases of azilsartan preparations were deferred for further deliberation in
next board meeting.

1. Azil tablets (Azilsartan Medoxomil 20mg,40mg, 80mg), M/s Helix Pharma Karachi.
Drug Azil tablets (Azilsartan Medoxomil 20mg,40mg, 80mg)

Source Jiangxi Synergy Pharmaceutical CO., Ltd. China
Storage Condition Real Time: 30°C and 65% RH
Accelerated: 40°C and 75% RH
Time Period Real Time: 6 months
Accelerated: 6 months
Frequency 0, 3, 6 months
Batch Size 400 Tablets, 400 Tablets, 400 Tablets,
No. of Batches 03
Sample Size 25 tablets
Meeting  Deferred 245th meeting of Registration
Board for stability data as per WHO
guidelines.
 Deferred in 255th meeting of registration
board for evaluation by committee.
Remarks  Significant change noticed in assay.
Documents / Data provided by the applicant (M/s Helix Pharma Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes
2. Approval of API by regulatory authority of country of Yes (Photocopy

origin or GMP certificate of API manufacturer issued by provided)
regulatory authority of country of origin.
3. Protocols followed for conduction of stability study and Yes
details of tests.
4. Data of 03 batches will be supported by attested Yes
respective documents like chromatograms, laboratory
reports, data sheets etc.
5. Documents confirming import of API etc. Yes (By courier only)
6. All provided documents will be attested (name, sign and Partially attested
stamp) for ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till Yes
assigned shelf life of the product.
Decision: Registeration Board deliberated on the matter of significant changes in the assay of
the API and decided to call technical team of firm for presentation on
aforementioned point before the Board.

2. Azil tablets 80 mg, Co-Azil 40/25 mg, M/s OBS Karachi.
Drug 1. Azil tablets 80 mg, (Azilsartan Kamedoximil)

2. Co-Azil 40/25 mg (Azilsartan Kamedoximi +
Chlorothalidone)
Source 1.Jiangxi Synergy Pharma Co. Ltd, China

2.Trichem Life Sciences India.
Frequency 0, 3, 6 months
Batch Size 2000 Tablets/ batch
No. of Batches 03
Sample Size 50 tablets
parameters Appearance, weight, dissolution, microbiology, assay,
Meeting Deferred 245th meeting of Registration Board for
stability as per WHO guidelines.
Remarks Firm has submitted a request for grant of registration of
Azil 40mg tablets and Co-Azil 40/12.5 mg based upon
above data.
Storage conditions not as per ICH Zone IV-A.
Significant change noticed in assay.
Documents / Data provided by the applicant
1. COA of API Yes
2. Approval of API by regulatory authority of country of origin or GMP Yes (Photocopies

certificate of API manufacturer issued by regulatory authority of provided)
country of origin.
3. Protocols followed for conduction of stability study and details of tests. Yes
4. Data of 03 batches will be supported by attested respective documents Yes
like chromatograms, laboratory reports, data sheets etc.
5. Documents confirming import of API etc. Yes (photocopy invoice
submitted)
6. All provided documents will be attested (name, sign and stamp) for Yes
ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till assigned shelf life Yes
of the product.
Decision: Registeration Board deliberated on the matter of significant changes in the assay of
the API and decided to call technical team of firm for presentation on
aforementioned point before the Board

3. M/s Genix Pharma Pvt Ltd.
Drug Lalap Syrup 10mg/per m l (Lacosamide)

Source Nutra Specialties pvt Ltd 69, chandrapadiya
village vinjamur mandal Nellore DT-524228
Indraspardash, India
Storage Condition Accelerated: 40°C±2°C/ 75% ±5% RH
Long Term: 30°C±2°C/ 65% ±5% RH
Time Period Accelerated: 06 months
Long Term: 24 months
Frequency 1,3,6,9,12,18,24months
Batch Size 5Liters / batch
No. of Batches 03
Sample Size 18 Packs
Meeting Deferred in 252nd meeting of registration board
for stability data
Documents / Data provided by the applicants (M/s Genix Pharma Pvt Ltd, Karachi.)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or
GMP certificate of API manufacturer issued by regulatory Yes
authority of country of origin.
3. Protocols followed for conduction of stability study and details Yes
of tests.
4. Data of 03 batches will be supported by attested respective Yes
documents like chromatograms, laboratory reports, data sheets
etc.
5. Documents confirming import of API etc. Yes
6. All provided documents will be attested (name, sign and stamp) Yes
for ensuring authenticity of data / documents.
7. Commitment to continue real time stability study till assigned Yes
shelf life of the product.
Decision: Registration Board decided to constituted following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents,
import of API, quality, specification, test analysis, facilities etc.
 Director DTL Quetta (Chairman),

 Director DTL, Karachi;
 Area FID, DRAP (Member/Convener).

M/s CCL Labs, Lahore
4 M/s CCL Labs, Diyacon Tablets Form-5-D

Lahore Each tablet Duplicate New
contains: file Molecule
Dapagliflozin Rs.50,000/-
5mg As per
SRO
5 M/s CCL Labs, Diyacon Tablets Form-5-D

Lahore Each tablet Duplicate New
Dapagliflozin 10 Rs.50,000/-
mg As per
SRO
Drug Diyacon Tablets

Dapagliflozin 5mg
Diyacon Tablets
Dapagliflozin 10 mg
Source Beijing Huikang boyuan chemical company ltd, China
Frequency 0,3,6
Batch Size 3,000 Tablets per batch
No. of Batches 3
Sample Size 50 tablets per batch
Documents / Data provided by the applicants

(M/s CCL Pharma Pvt Ltd, Lahore.)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin
or GMP certificate of API manufacturer issued by regulatory Yes
authority of country of origin. (Photocopy)
details of tests.
documents like chromatograms, laboratory reports, data

sheets etc.
(Commercial invoice not
attested)
6. All provided documents will be attested (name, sign and Yes
Decision: Registration Board decided to constituted following panel for onsite investigation to
confirm genuineness/ authenticity of stability data and associated documents,
import of API, quality, specification, test analysis, facilities etc.
 Director DTL Peshawar (Chairman),

 Director DTL, Lahore;
 Area FID, DRAP (Member/Convener).
6 M/s CCL Labs, Dacvir Form-5-D

Lahore Tablets Duplicate New
Each film coated tablet file Molecule
contains: Rs.50,000/-
Daclatasvir Dihydrochloride As per SRO
equivalent to Daclatasvir
……30mg
Mfg Specs
7 M/s CCL Labs, Dacvir Form-5-D

Lahore Tablets Duplicate New
Each film coated tablet file Molecule
contains: Rs.50,000/-
Daclatasvir Dihydrochloride As per SRO
equivalent to Daclatasvir
……60mg
Mfg Specs
Drug Dacvir
Tablets
Daclatasvir Dihydrochloride equivalent to Daclatasvir
……30mg
Mfg Specs
Dacvir
Tablets
Daclatasvir Dihydrochloride equivalent to Daclatasvir
……60mg
Mfg Specs

Source Ruyuan HEC pharam Ruyuan county guangdond China
Frequency 0,3,6
Batch Size 1000 Tablets
No. of Batches 3
Sample Size 50 Tablets

(M/s CCL Pharma Pvt Ltd, Lahore .)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin The GMP certificate
or GMP certificate of API manufacturer issued by regulatory provided by the firm
authority of country of origin. shows scope of
inspection for bulk drug
is (Azithromycin,
Sofosbuvir, Ledipasvir)
details of tests.
sheets etc.
(Performa invoice not
attested)
6. All provided documents will be attessted (name, sign and Yes
Decision: Registration Board decided to constitute the following panel for onsite
investigation to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis,
facilities etc.
o Brig. (R) M.H. Najmi, Member Registration Board.

o Dr. Obaidullah, DDG (Reg-I), DRAP, Islamabad.
o Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.

M/s Pharmevo, Karachi
8 M/s PharmEvo, Dakvir tablet Form 5-D

Karachi Each film coated tablet Duplicate New
Daclatasvir (as Rs: 50,000
dihydrochloride) 60 mg As per PRC
Mfg Specs
Drug Dakvir tablet

Daclatasvir (as dihydrochloride) 60 mg
Mfg Specs
Source Virupaksha organics India

Frequency 0,3,6
Batch Size 2500 Tablets
No. of Batches 3

(M/s Pharm Evo Pvt Ltd, Karachi .)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin Yes
or GMP certificate of API manufacturer issued by regulatory (However the proof of
authority of country of origin. approval of API not
attached )
3. Protocols followed for conduction of stability study and details No
of tests.
etc.
6. All provided documents will be attessted (name, sign and Yes


Decision: Registration Board decided to constitute the following panel for onsite
investigation to confirm genuineness/ authenticity of stability data and
associated documents, import of API, quality, specification, test analysis,
facilities etc.
o Brig. (R) M.H. Najmi, Member Registration Board.

o Dr. Obaidullah, DDG (Reg-I), DRAP, Islamabad.
o Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.
M/s English Pharma Pvt Ltd, Lahore.
Drug Esovir 400mg Tablet (Sofosbuvir)

Source M/s Pharmagen, Lahore
Frequency 0,1,3,6
Batch Size Not provided
No. of Batches 3
Sample Size Not provided

(M/s English Pharma Pvt Ltd, Lahore.)
1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or Yes
GMP certificate of API manufacturer issued by regulatory
authority of country of origin.
3. Protocols followed for conduction of stability study and details No
of tests.
4. Data of 03 batches will be supported by attested respective Not Attested
etc.
5. Documents confirming import of API etc. Not Appied
6. All provided documents will be attessted (name, sign and No

7. Commitment to continue real time stability study till assigned No
Decision: Registration Board deferred case for completion of documents as recorded above.

M/s Getz Pharma, Karachi
9 M/s Getz Pharma, Verna tablets 30 mg Form 5-D

Karachi Each film coated Tablet : Dy no: 365 New
Daclatasvir dated: Molecule
dihydrochloride equivalent08..09.2015
to Rs: 50,000
Daclatasvir…………30mg Price:
30000/ 28
Tablets
Price;
1071.42/per
tablet
10 M/s Getz Pharma, Verna tablets 60 mg Form 5-D
Karachi Each film coated Tablet : Dy no: 364 New
Daclatasvir…………60mg dated: Molecule
08..09.2015
Rs: 50,000
Price:
50000/ 28
Tablets
Price;
1785.42/per
tablet
Drug Verna tablets 30 mg

Each film coated Tablet :
Daclatasvir dihydrochloride equivalent to
Daclatasvir…………30mg
Verna tablets 60 mg
Each film coated Tablet :
Daclatasvir…………60mg
Source Zhejiang apeloa kangyu Pharmaceutical company limited
Zhejiang, China
Frequency 0,1,2,3,6
Batch Size Not available
No. of Batches 3
Sample Size Not available
Remarks The firm has informed that they have developed
daclatasvir 60mg tablet from shanghai forefront pharma
company Ltd China (contract development China- R&D
company) and through technology transfer they have
reproduced the same product at their facility. Further,
Getz phama has manufacturer 03batches of the drug using

same technology and 03months stability data has been
completed.

(M/s Getz Pharma Pvt Ltd, Karachi .)
1. COA of API Yes

or GMP certificate of API manufacturer issued by regulatory The GMP certificate
authority of country of origin. provided by the firm
shows scope of
inspection for bulk drug
(Ofloxacin,
levofloxacin,
rimantadine, Ubenimex)
details of tests.
sheets etc.
5. Documents confirming import of API etc. NO

Decision: Registration Board deferred the case for scientifically rationale lab scale stability
data for six months as per recommendatons of the Board.
M/s CCL Pharma, Lahore
11 Lebriva Tablet Form 5-D

Each Tablet contains: Dy no: 705 dated:
Ledipasvir……..90mg 08.02.2016
Sofosbuvir………400mg Rs: 50,000
Mfg Specs Not applicable
Drug Lebriva Tablet

Each Tablet contains:
Ledipasvir……..90mg
Sofosbuvir………400mg
Mfg Specs
Source Ruyuan HEC pharam Ruyuan county guangdond China
Jiangxi Synergy Pharmaceutical Company limited China

Frequency 0,3,6
Batch Size 1000 tablets
No. of Batches 3

(M/s CCL Pharma Pvt Ltd, Lahore .)
1. COA of API Yes

(The firm has provided
COA of two different
companies )
or GMP certificate of API manufacturer issued by regulatory Yes
authority of country of origin. (Photocopy Provided)
details of tests.
etc.
(not clear from the
invoice that from which
source the firm has
imported the API)
Decision: Registeration Board deferred the case for clarification regarding source of
API used for conducting stability studies.

Registration of Aprovasc Range (Irbesartan + Amlodipine).
Following case of M/s Sanofi Aventis, Karachi was discussed in 257th meeting and decided as
follows:
Registration Board in its 245th meeting discussed following products of M/s Sanofi Aventis,
Karachi and advised the firm to provide status about availability of products in SRAs and provide safety
and efficacy data of the drugs along with complete clinical trial data of these formulations.
S. No Name of drug(s) & Composition
I. Aprovasc 300/10mg Tablet

Irbesartan……….300 mg
Amlodipine besylate.14 mg eq. to amlodipine…10 mg
(Antihypertensive, angiotensin II receptor antagonist)
II. Aprovasc 150/10mg Tablet
Amlodipine besylate.14 mg eq. to amlodipine…10 mg
III. Aprovasc 150/5mg Tablet
Amlodipine besylate.7 mg eq. to amlodipine……5 mg
IV. Aprovasc 300/5mg Tablet
Amlodipine besylate.7 mg eq. to amlodipine……5 mg
In response, the firm had submitted that the fixed dose combination of Irbesartan + Amlodipine
(in the strength of Irbesartan 100mg /Amlodipine 5mg and Irbesartan 100mg /Amlodipine 10 mg) is
registered with PMDA Japan by the name of AIMIX by Daipinppon Suitomo Pharma. They have
submitted that as the dosing in Japan is considerably lower than the USA or Europe therefore the fixed
dose combinations are of lower strength.
They have informed that that three Bioequivalence studies have been conducted for Aprovasc and
the results of these had been submitted to DRAP for review and these studies show that the combination
of Irbesartan + Amlodipine versus free individual molecule is safe and well tolerated. Apart from these 2

randomized, open-label, multicenter, phase III trials were conducted and published in peer reviewed index
Journal, Clinical therapeutics (2012) and no untoward side effects were observed with this combination
other than those already reported for the individual drugs.
Registration Board in its 249th meeting discussed the case in view of the submission made by the firm and
following decision was taken:
“Registration Board referred the clinical data to Pharmacy Services Division for evaluation.”
 Division of Pharmacy Services has now submitted evaluation report as under:
“The clinical study data attached by the company have been studied. The pharmacokinetic,
Pharmacovigilance, safety, efficacy data provided by the company was evaluated. The representatives of
the company who are involved in clinical research were asked to explain the need of combination
medicines and their beneficial effects on hypertension patients.
The research articles, studies carried out on the above combination medicine provided by the company
and the discussion made with the expert reveals that the products could be approved for registration. Such
combination products with Amlodipine and valsartan are already available in the market. The products
may be considered by the Registration Board after completing other required codal formalities”
Decision (257th meeting): Registration Board deferred the case for detailed deliberation in the
light of report of Pharmacy Services Division.
Decision: Registeration Board deferred the case for further deliberation.

Item No.III: Biological Drugs Division.
Case No.01: Cases of imported human biological drugs from non reference countries.
”In 255th meeting of Registration Board it was apprised that registration

applications for finished imported products are submitted with Certificate of Pharmaceutical Products
(CoPP) and in some cases, CoPP is without any expiry date. The Board decided to consider such CoPP
valid for 05 years from date of issuance. Moreover, Registration Board also decided to consider
registration applications of those imported products whose CoPPs was valid at time of submission of
application and later on expired during processing of the application. In such cases, application will be
considered by Registration Board and firm will be advised to provide valid CoPP. Registration letter will
be issued after submission of legalized CoPP after approval of chairman, RB. Accordingly the following
cases require consideration by the Registration Board”
S.#. Name of Brand Name & Type of Form Document Remarks Decision
Importer & Composition Dy No & Date of details (CoPP)
Manufacturer application Me too
Fee submitted status/New
Pack size/ molecule
Demanded Price
1. M/s Medibid KXING-GCSF Form 5-A COPP No. Valid and Deferred for
First floor, 300ug/ml PFS WHO-CPP- legalized COPP/ expert opinion
Shafi Court Dy No. 2232 R&I CERT-JN- FSC along with of following
Merewether Recombinant dated 15-4-2013 131211 dated GMP Certificate and valid
Road, Civil human 17-2-2013 need to be
Fee deposited Rs. legalized
Lines, Karachi. granulocyte from Republic submitted as per
15000/- dated 19-4- COPP/FSC &
colony- of China above decision of
stimulating 2012 + Rs. 35000/- 255th meeting.
GMP:
Shandong factor injection dated 13-11-2013 + Product
Rs. 50000/- dated a. Brig. Tariq
Kexing License No. Condition of Satti,
Bioproducts Strength of 12-1-2015 GYZZ inspection abroad AFBMTC,
Co., Ltd. active Shelf life: 24 S20103004 as per import Islamabad.
Mingshui ingredients: months dated 29-4- policy. b. Brig.
development 300ug/ml/Pre 2010 Qamar-un-
Zone, Filled Syringe Pack size: 300ug/ml Nisa,
Zhangqiu, Pre filled Free Sale AFBMTC,
Shandong, syringe/small Certificate No. Islamabad
China. carton, 10 2013-023 c. Dr Shamsi,
syringes/middle dated 17-2- Karachi
carton, 320 2013 valid for
syringes/big carton two years

Demanded Price.
Rs.4500/- per vial.
2. M/s Medinet FILATIL Dy. No. 1798 (R&I) GMP Valid and Deferred for
Pharmaceutical Prefilled Syringe DRAP (TF) Certificate No. legalized COPP/ expert opinion
s, Rawalpindi 300MCG/1ML Dated 21-11-2014 113300IT0114 FSC along with of following
(Filgrastim) 73 dated 05-7- GMP Certificate and valid
Fee deposited: Rs. 2011 need to be
legalized
Probiomed S.A Active 50000/- dated 17- submitted as per
COPP/FSC &
de C.V. ingredient: 11-2014 + Product above decision of
San Esteban Filgrastim……3 Rs.50000/- dated Registration 255th meeting.
GMP:
No.88, Col. 00MCG/1ML 15-3-2016 No. a. Brig. Tariq
Santo Tomas, 101M2001S.S. Condition of Satti,
C.P. 02020, Antineoplastic A. inspection abroad AFBMTC,
Deleg, as per import Islamabad.
Azcapotzalco, Shelf life : 24 Free sale policy. b. Brig.
D.F., Mexico. months certificate No. Qamar-un-
113300516B1 Nisa,
305 dated 23- AFBMTC,
8-2011 valid Islamabad.
until 24 c. Dr Shamsi,
months Karachi
Sanitary
License No. 09
002 02 0001
Date of expiry
30-1-2009
Date of
translation 27
July, 2011
3. M/s Medinet BIOYETIN Dy No. 1164 (R&I) GMP Valid and Deferred for
Pharmaceutical Multi dose DRAP (TF) dated Certificate No. legalized COPP/ expert opinion
s, Rawalpindi 10,000IU 26-2-2015 113300IT0114 FSC along with of following
(Recombinant 73 dated 05-7- GMP Certificate and valid
Human Fee deposited: Rs. 2011 need to be
legalized
Probiomed S.A Erythropoietin) 50000/- dated 26-2- submitted as per
COPP/FSC &
de C.V. 2015 + Rs.50000/- Free sale above decision of
San Esteban dated 15-3-2016 certificate No. 255th meeting.
GMP:
No.88, Col. Each 2ml vial 093300516B1 a. Dr. Ghias
Santo Tomas, contains: As per DRAP policy 213 dated 02- Condition of But, PIMS,
C.P. 02020, Recombinant 5-2009 valid inspection abroad Islamabad.
Deleg, Human until 24months as per import
Azcapotzalco, Erythropoietin--- from the policy.

D.F., Mexico. --10,000IU country of b. Maj. Gen.
origin. Sohail
: Product Sabir, MH,
Anti anemic Registration Rawalpindi.
agent No. 306M98
Hematopoietic S.S.A. c. Dr.Sami
Growth Factor siraj, KMU,
Sanitary Peshawar.
License No. 09
002 02 0001
Date of expiry
30-1-2009
Date of
translation 27
July, 2011
Pharmaceutical PFS 4000IU DRAP (TF) dated Certificate No. legalized COPP/ expert opinion
s, Rawalpindi (Recombinant 26-2-2015 113300IT0114 FSC along with of following
Human 73 dated 05-7- GMP Certificate and valid
Erythropoietin) Fee deposited: 2011 need to be
legalized
Probiomed S.A Rs. 50000/- dated submitted as per
COPP/FSC &
de C.V. Strength & 26-2-2015 + Free sale above decision of
San Esteban Active Rs.50000/- dated certificate 255th meeting.
GMP:
No.88, Col. ingredients: 15-3-2011. letter
Santo Tomas, One pack of No.093300516 Condition of
C.P. 02020, Bioyetin 4000IU B1213 dated inspection abroad a. Dr. Ghias
Deleg, PFS Contains: 02-5-2009 as per import But, PIMS,
Azcapotzalco, Pre Filled valid until 24 policy. Islamabad.
D.F., Mexico. Syringes of months from
0.30ML Each. the country of
origin. b. Maj. Gen.
Recombinant Sohail, MH,
Human Product Rawalpindi.
Erythropoietin… Registration
…4000IU No. 306M98
Pharmacological S.S.A. c. Dr.Sami
group: siraj, KMU,
Antianemic Sanitary Peshawar.
agent License No. 09
Hematopoietic 002 02 0001
Growth Factor Date of expiry
30-1-2009
Date of

translation 27
July, 2011
Pharmaceutical PFS 2000IU DRAP (TF) Certificate No. legalized COPP/ expert opinion
s, Rawalpindi (Recombinant Dated 26-2-2015 113300IT0114 FSC along with of following
Human 73 dated 05-7- GMP Certificate and valid
Erythropoietin) Fee deposited: Rs. 2011 need to be
legalized
Probiomed S.A 50000/- dated 26-2- submitted as per
COPP/FSC &
de C.V. Strength & 2015 + Rs. 50000/- Free sale above decision of
San Esteban Active dated 15-3-2016. certificate 255th meeting.
GMP:
No.88, Col. ingredients: letter a. Dr.
Santo Tomas, One pack of No.093300516 Condition of GhiasBut,
C.P. 02020, Bioyetin 2000IU B1213 dated inspection abroad PIMS,
Deleg, PFS Contains: 02-5-2009 as per import Islamabad.
Azcapotzalco, Pre Filled valid until 24 policy. b. Maj Gen.
D.F., Mexico. Syringes of months from Sohail, MH,
0.30ML Each. the country of Rawalpindi.
origin.
Recombinant c. Dr.Sami
Human Product siraj,,
Erythropoietin… Registration KMU,
…2000IU No. 306M98 Peshawar
Pharmacological S.S.A.
group:
Antianemic Sanitary
agent License No. 09
Hematopoietic 002 02 0001
Growth Factor Date of expiry
30-1-2009
Date of
translation 27
July, 2011
6. M/s La-Vie Hecolin ® Dy. No. 2224 (R&I) New molecule The new Deferred for
(Pvt) Ltd., 0.5ml/dose PFS DRAP (TF) molecule for confirmation of
Lahore Each 0.5ml dose Dated 12-5-2016 GMP treatment of approval status
contains:- Certificate No. hepatitis E by reference
Manufacturer 30 ug of purified Fee deposited: Rs. CN20120056 require expert
regulatory
M/s xiamen recombinant 50000/- dated dated 09-7- evaluation from
authorities and
Innovax Hepatitis E virus 10.5.2016 2012 valid hepatalogists.
Biotech Co., antigen upto 08-7-
expert opinion
Ltd., 2017 Condition of of following
130.Xinyuan Shelf life : 36 inspection abroad pertaining to
Road, Haicang months Free Sale as per import requirement of
District, Certificate No. policy will Hepatitis E

Exiamen, 2016002 dated prevail. virus vaccine in
Fujian 8.1.2016 country,
Province, PR keeping in view
China. its
prevelance,epid
emiology,
domestic
requirement etc.
a. Dr. Huma
Qureshi,
PHRC,
Islamabad
b. Prof, Dr.
Umar, Holy
Family
Hospital,
Islamabad
7. M/s La-Vie Hirax Injection Dy. No.886 (R&I) New molecule Evidence of Deferred for
(Pvt) Ltd., Each 0.5 ml DRAP (TF) availability in confirmation of
Lahore (vial) contains:- Dated 15-2-2016 CoPP No. reference drug approval status
2014-F1-0121 agencies is by reference
Manufacturer Hyaluronidase… Fee deposited: Rs. dated required.
regulatory
M/s BMI Korea …. 750 IU 50000/- dated 24.4.2014
authorities
Co., Ltd., 11,7 08.2.2016. (validity not
Gill, Chedanro, Enzyme mentioned)
including
Jeju-si, Jeju-do, indications.
690,140 Korea. (Enhance GMP
permeation of Certificate No.
Subcutanious or 2014-F1-0172
Intramuscular dated 07-7-
Injections, local 2014
anesthetics and Free Sale
subcutaneous Certificate No.
infusions.) 2014-F1-0120
dated
24.4.2014
8. M/s La-Vie Hirax Injection Dy. No.4666 (R&I) New molecule Product is Deferred for
(Pvt) Ltd., Each 1ml (vial) DRAP (TF) available confirmation of
Lahore contains:- Dated 28-7-2015 CoPP No. internatioally in approval status
Hyaluronidase… 2014-F1-0121 reference by reference
Manufacturer …. 1500 IU Fee deposited: Rs. dated agencies under
regulatory
M/s BMI Korea 50000/- dated 24.4.2014 the name of
authorities
Co., Ltd., 11,7 (Enhance 09.7.2015 GMP HYLASE of

Gill, Chedanro, permeation of Certificate No. Wockhardt UK as including
Jeju-si, Jeju-do, Subcutanious or 2014-F1-0172 freeze dried indications.
690,140 Korea. Intramuscular dated 07-7- formulation
Injections, local 2014 (powder) in
anesthetics and Free Sale ampoule,
subcutaneous Certificate No. however tha
infusions.) 2014-F1-0120 applied product is
dated solution in vial.
24.4.2014 The lyphollized
formulation is
included in BP.
9. Venture RHOCLONE Form-5A Legalized The product was Deferred for
Pharmaceutical 300 MCG Valid COPP discussed in the
s (Pvt) Ltd, Dy. No. 1218 (R&I) No. 257th meeting and a. Confirmation
Karachi. Anti Rho-D DRAP dated 25-2- COPP/CERT/ deferred for of approval
Immuno 2016 KD/42264/201 submission of status by
Bharat Serums globulin 6/11/14803/73 vaild legalized reference
and Vaccines Injection Fee Deposited: 243 valid up to CoPP. Now the regulatory
Limited (Monoclonal) Rs.100000/- dated 01-10-2016 Firm has authorities.
Plot No. K-27, (Liquid 03-2-2016 submitted Valid
Anand Nagar, Injection) Product legalized CoPP b. References
Additional vial License No. valid upto 01-10- pharmacopias
M.I.D.C. Each ml KD5 in Form 2016.
Ambernath contains: 28E c. Importability
(East), India Anti Rho-D Dated 07-2- Evidence of as per import
Immunoglobulin 2011 availability in policy order
….300mcg/ reference drug from India
1500 IU Legalized agencies is
GMP required as the d. Safety
Water for Certificate No. Pharmacopieal profile, clinical
Injection NEW-WHO- preparation (BP) efficacy, and
U.S.P…q.s GMP/CERT/K contains specific clarification as
D/12788/2014/ antibodies against the
Immune Sera 11/6320 dated erythrocyte D-
Pharmacopieal
and 04-4-2014 antigen and may
preparation
Immunoglobulin also contain small
Anti-D (Rh) quantities of (BP) contains
Immunoglobulin other blood-group specific
ATC code: J06B antibodies. antibodies
B01 However the against
applied erythrocyte D-
Shelf life: 24 formulation antigen and
months contains only IgG may also
antibodies. contain small

Condition of quantities of
inspection abroad other blood-
as per import group
policy. antibodies.
However the
applied
formulation
contains only
IgG antibodies.
10. M/s Opulent ALBUREL Form-5A Legalized As per COPP, the Deferred for
International (Human Normal CoPP/CERT/ product is
clarification
Karachi. Albumin IP Dy. No 1120 dated KD/42047/201 licensed to be about non
20%) 28-05-2014 6/11/14718/72 placed in the abailability of
M/s Reliance 804 dated 30- market for use in
product in the
Life Sciences, Each 100 ml vial Rs.100000 dated 28- 4-2016 valid the exporting
country of
of Dhirubhai contains: 06-2013 upto 31-12- country; however
Ambani Life Total 2017 product is not
origin and valid
Sciences Center protein….200g/ 60USD / vial available in the reason thereof
(DALC),Plant L market in the by the
No. 4B, Plot Sodium country of origin.regulatory body
No. R-282, Caprylate…..6.6 and
TTC Area of 5g/ L Condition of confirmation of
MIDC, Rabale Na+ not more inspection abroad availability of
Thane Belapur than…160mM/L as per import similar products
Road Navi K+ not more policy. in country.
Mumbai India. than…..2mM/ L
Aluminum…..≤
200µg/ L
Human Albumin
–Plasma protein
Shelf life : 36
months
11. M/s Opulent ALBUREL Form-5A Legalized As per COPP, the Deferred for
International (Human Normal CoPP/CERT/ product is clarification
Karachi. Albumin IP Dy. No 1119 dated KD/42047/201 licensed to be about non
20%) 28-05-2014 6/11/14718/72 placed in the abailability of
M/s Reliance 804 dated 30- market for use in
product in the
Life Sciences, Each 50 ml vial Rs. 100000 dated 4-2016 valid the exporting
country of
of Dhirubhai contains: 28-06-2013 upto 31-12- country; however
Ambani Life Total 2017 product is not
origin and valid
reason thereof

Sciences Center protein….200g/ 30USD / vial available in the by the
(DALC),Plant L market in the regulatory body
No. 4B, Plot Sodium country of origin. and
No. R-282, Caprylate…..6.6 confirmation of
TTC Area of 5g/ L Condition of
availability of
MIDC, Rabale Na+ not more inspection abroad
similar products
Thane Belapur than…160mM/L as per import
Road Navi K+ not more policy.
in country.
Mumbai India. than…..2mM/ L
Aluminum…..≤
200µg/ L
Human Albumin
–Plasma protein
Shelf life : 36
months
12. M/s Opulent IMMUNOREL Form-5A Legalized As per COPP, the Deferred for
International (Human Normal CoPP product is
clarification
Karachi. Immunoglobulin Dy. No 11198 dated /CERT/MD/26 licensed to be about non
for Intravenous 28-05-2014 507/2015/11/1 placed in the abailability of
M/s Reliance Administration) 0485/48262 market for use in
product in the
Life Sciences, 100000 dated 28-06- dated 28-4- the exporting
country of
Pvt Limited, Each 50ml 2013 2015 valid country; however
Plant-1 Sandhra contains: upto 09-3- product is not
origin and valid
Textile Mills 98 USD / vial 2017 available in the reason thereof
Compound, Protein…..50g/ market in the by the
Ground and L country of origin.regulatory body
First Floor C.S. IgG…..2.5g and
No. 1621 Plot Stabilizer Condition of confirmation of
No. 3 Plan 1 Maltose…..100g inspection abroad availability of
Pandurang /L as per import similar products
Budhkar, Marg IgA content≤ policy. in country.
Worli Mumbai. 80mg/L
IgG
subclases……N
ormal
distribution
Immunoglobulin
s
Shelf life: 36
months

13. M/s Hakim HuCoG- 5000 Form-5A Legalized Valid andDeferred for
sons (Impex) HP CoPP No: legalized COPP/ submission of
Pvt Limited, Dy No. 279 R&I CoPP/ CERT/ FSC along with valid legalized
Hakim sons Each vial dated 15-01-16 KD/ 16870/ GMP Certificate COPP,
Building, 19 contains: 2014/ 11/ need to be
confirmation of
West Warf Chorionic Fee Rs.100000/- 6610/ 292156/ submitted as per
availability of
Road, Karachi Gonadotropin dated 12-01-2016 valid up to 01- above decision of
Pakistan BP……5000 I.U 04-2016 255th meeting.
similar products
in country and
M/s Bharat Gonadotropins Legalized Condition of expert opinion
Serum and GMP No: inspection abroad of following:
Vaccines Indications: New-WHO- as per import
Limited, Plot An ovulatory GMP/ CERT/ policy. a. Brig.
No K-27 Anaa Fertility, KD/ 12788/
Muzamil
Hussain
nd Nagar, Hypogonadism 2014/ 11/ 6320
Najmi,
Additional and valid up to 01-
Member
MIDC Cryptorchidism 04-2016
Registration
Ambernath Board
(East) India. Shelf life: 24 b. Brig, Aamir
months Ikram,
AFIP,
Rawalpindi.
c. Dr. Masud-
ur-Rehman,
DDG,
DRAP
14. M/s Hakim BSV HUMOG Form-5A Legalized Valid and Deferred for
sons (Impex) 75 HP CoPP No: legalized COPP/ submission of
Pvt Limited, Dy No. 280 R&I CoPP/ CERT/ FSC along with valid legalized
Hakim sons Each vial dated 14-01-16 KD/ 26812/ GMP Certificate COPP,
Building, 19 contains: 2015/ 11/ need to be
confirmation of
West Warf Menotropin BP Fee Rs.100000/- 10547/ 48878/ submitted as per
availability of
Road, Karachi equivalent to dated 12-01-2016 valid up to 01- above decision of
Pakistan activity of 04-2016 255th meeting.
similar products
Follicle in country and
M/s Bharat Stimulating Legalized Condition of expert opinion
Serum and Hormone……75 GMP No: inspection abroad of following:
Vaccines IU New-WHO- as per import
Limited, Plot Luteinizing GMP/ CERT/ policy. a. Brig.
No K-27 Anaa Hormone……75 KD/ 12788/
Muzamil
Hussain
nd Nagar, IU 2014/ 11/ 6320
Najmi,
Additional valid up to 01-
Member
MIDC Hormone 04-2016
Registration

Ambernath Board
(East) India. Shelf Life: 36 b. Brig, Aamir
months Ikram,
AFIP,
Rawalpindi.
c. Dr. Masud-
ur-Rehman,
DDG,
DRAP
15. Hospital EPOREL-10,000 Form 5A Legalized Free Valid and Deferred for
Services & I.U PFS Sale legalized COPP/ submission of
Sales 13-C 10-10-2014 Certificate No. FSC along with valid legalized
Annexe, Block Each 1.0ml D&C/841/201 GMP Certificate COPP and
6, P.E.C.H.S, contains: Fee Rs.100000/- 110/-00525-4 need to be
expert opinion
Shahrah-e- Erythropoietin dated 10-10-2014 Dated 09-11- submitted as per
of following:
Faisal, Karach concentrated 2011 above decision of
75400. (rhEPO) Ph Eur Rs. 6086/- pack of 255th meeting. a. Dr. Toqeer
……10,000 1’s Legalized Raza,
Manufacturer: CoPP Condition of NUST,
M/s. Reliance Blood Forming provided, valid inspection abroad Islamabad
Life Sciences, Agent up to 19-03- as per import b. Dr. Huma
Limited 2014 policy. Qureshi,
Dhirubhai Shelf life: 24 PMRC,
Ambani Life months Product Islamabd
Sciences Center License No. c. Dr. Sami J
(DALC), KD/7 Khan
R-282, TTC Dated 28-04-
Industrial Area, 2014
Thane Belapur
Road, Rabale, Legalized
Navi Mumbai, GMP
Maharashtra, provided, valid
India up to 19-03-
2014.
16. Hospital EPOREL-2000 Form 5A Legalized Free Valid and Deferred for
Annexe, Block Each 0.5ml D&C/841/201 GMP Certificate COPP and
expert opinion
of following:
……2000 1’s Legalized Raza,

(DALC), KD/7 Khan
R-282, TTC Dated 28-04-
Thane Belapur
Navi Mumbai, GMP
India up to 19-03-
2014.
17. Hospital EPOREL-4000 Form 5A Legalized Free Valid and Deferredfor
Annexe, Block Each 0.4 ml D&C/841/201 GMP Certificate COPP and
expert opinion
of following:
……4000 1’s Legalized Raza,
(DALC), KD/7 Khan
R-282, TTC Dated 28-04-
Thane Belapur
Navi Mumbai, GMP
India up to 19-03-
2014.
18. Hospital APIGRAST Form-5A Legalized Free Valid and Defered for
Services & 300µg PFS Sale legalized COPP/ expert opinion
Sales 13-C 02-09-2014 Certificate No. FSC along with of following
Annexe, Block Each 0.5ml D&C/841/201 GMP Certificate and valid

6, P.E.C.H.S, contains: Fee Rs.100000/- 110/-00525-4 need to be legalized
Shahrah-e- Filgrastim dated 02-09-2014 Dated 09-11- submitted as per COPP/FSC &
Faisal, Karach concentrated 2011 above decision of GMP:
75400. solution Ph. Rs.4910/- Pack of 255th meeting.
Eur… 300µg 1’s Legalized a. Brig. Tariq
Manufacturer: CoPP Condition of Satti,
M/s. Reliance Antineoplastic provided, valid inspection abroad AFBMTC,
Life Sciences, and up to 19-03- as per import Islamabad.
Pvt Limited Immunomodulat 2014 policy. b. Brig.
Dhirubhai or Qamar-un-
Ambani Life Product Nisa,
Sciences Center Shelf life: 24 License No. AFBMTC,
(DALC), months KD/7
Islamabad.
c. Dr Samsi
R-282, TTC Dated 28-04-
Karachi
Thane Belapur
Navi Mumbai, GMP
India up to 19-03-
2014
19. Hospital CARDIRAL Form 5A Legalized Free Valid andDeferred for
Services & 18mg/ 10Units Sale legalized COPP/ confirmation of
Sales 13-C Per Vial (Sterile 100000 dated 02-09- Certificate No. FSC along with approval status
Annexe, Block lyophilized 2014 D&C/841/201 GMP Certificate by reference
6, P.E.C.H.S, powder for 110/-00525-4 need to be
regulatory
Shahrah-e- injection) Dated 09-11- submitted as per
authorities,
Faisal, Karach 47188/- pack of 2 2011 above decision of
75400. Each vial single use vials, 2 255th meeting.
local
contains: ampoules of 10ml Legalized availability of
Manufacturer: Reteplase sterile water of CoPP Condition of similar products
M/s. Reliance (Recombinant injection, 2 single provided, valid inspection abroad and provision
life sciences Tissue use 10 ml syringes, up to 19-03- as per import of valid
Pvt. Ltd., Plasminogen 4 sterile needles. 2014 policy. legalized
Dhirubhai Activator) Product COPP/FSC &
Ambani Life …….…. 18mg License No. GMP.
Sciences Center Tranexamic KD/7 Tranexamic acid
(DALC), acid... 8.32mg. Dated 28-04- is used as
R-282, TTC excipient in
2014 formulation
Industrial Area, Antithrombotic
which require
Thane Belapur Legalized clarification from
Road, Rabale, Shelf life: 24 GMP the firm.
Navi Mumbai, months provided, valid
Maharashtra, up to 19-03-

INDIA. 2014
20. Hospital APFERON Form 5A Legalized Free Valid and Deferred for
Services & 5MIU vial Sale legalized COPP/ submission of
Sales 13-C 100000 dated 02-09- Certificate No. FSC along with valid legalized
Annexe, Block Each 0.5ml 2014 D&C/841/201 GMP Certificate COPP and
6, P.E.C.H.S, contains: 110/-00525-4 need to be
expert opinion
Shahrah-e- rH Interferon Rs. 1936/- Pack of Dated 09-11- submitted as per
of following:
Faisal, Karachi alfa 2b Ph. Eur. 1’s 2011 above decision of
75400. …………..… 5 255th meeting. a. Prof. Dr.
MIU Legalized Muhammad
Manufacturer: CoPP Condition of Umar, Holy
M/s. Reliance Cytokines and provided, valid inspection abroad Family
life sciences Immunomodulat up to 19-03- as per import Hospital,
pvt. Ltd., or 2014 policy. Islamabad.
Dhirubhai b. Dr. Huma
Ambani Life Shelf life : Product Qureshi,
Sciences Center 2years License No. PMRC,
(DALC), KD/7 Islamabad.
R-282, TTC Dated 28-04- c. Dr. Nasir
Industrial Area, 2014 Jalal,
Thane Belapur NUST,
Road, Rabale, Legalized Islamabad.
Navi Mumbai, GMP
INDIA. up to 19-03-
2014
21. Hospital APFERON Form 5A Legalized Free Valid and Defered for
Services & 3MIU vial Sale legalized COPP/ submission of
Sales 13-C 100000 dated 02-09- Certificate No. FSC along with valid legalized
Annexe, Block Each 0.5ml 2014 D&C/841/201 GMP Certificate COPP and
6, P.E.C.H.S, contains: 110/-00525-4 need to be
expert opinion
Shahrah-e- rH Interferon Rs. 1134/- Pack of Dated 09-11- submitted as per
of following:
Faisal, Karachi alfa 2b Ph. Eur. 1’s 2011 above decision of
75400. …………..… 3 255th meeting. a. Prof. Dr.
MIU Legalized Muhammad
Manufacturer: CoPP Condition of Umar, Holy
M/s. Reliance Cytokines and provided, valid inspection abroad Family
life sciences Immunomodulat up to 19-03- as per import Hospital,
pvt. Ltd., or 2014 policy. Islamabad.
Dhirubhai b. Dr. Huma
Ambani Life Shelf life : Product Qureshi,
Sciences Center 2years License No. PMRC,

Thane Belapur NUST,
Navi Mumbai, GMP
INDIA. up to 19-03-
2014
22. Hospital RELIBETA Form-5A Legalized Free Valid and Defered for
Services & 30µg – 0.5ML Sale legalized COPP/ submission of
Sales 13-C PFS ( 10-10-2014 Certificate No. FSC along with valid legalized
Annexe, Block D&C/841/201 GMP Certificate COPP and
6, P.E.C.H.S, Each 0.5ml in Deposited fee 110/-00525-4 need to be
expert opinion
Shahrah-e- PFS contains: 100000 Dated 09-11- submitted as per
of following:
Faisal, Karach Recombinant 2011 above decision of
75400. Interferon beta 30430/- Pack of 1’s 255th meeting. a. Prof. Dr.
1a …………… Legalized Muhammad
Manufacturer: 30µg CoPP Condition of Umar, Holy
M/s. Reliance provided, valid inspection abroad Family
life sciences Cytokines up to 19-03- as per import Hospital,
pvt. Ltd., 2014 policy. Islamabad.
Dhirubhai Shelf life: 2 b. Dr. Huma
Ambani Life years Product Qureshi,
Sciences Center License No. PMRC,
Thane Belapur NUST,
Navi Mumbai, GMP
INDIA. up to 19-03-
2014
23. The Searle TUXIMAB 09 -6-2015 CoPP letter No Valid and Deferred for
Company Ltd Injection .20132019 legalized COPP/ submission
First floor 100mg/10ml Fee Deposited 000140 dated FSC along with valid legalized
NICL Building 17-4-2015 GMP Certificate COPP and
Abbasi Each vial Rs.100000/- vide valid for need to be
expert opinion
Shaheed Road , contain challan No. twelve months. submitted as per
of following:
Karachi 75530 100mg/10ml of 0233078 dated 18-5- above decision of
Rituximab 2015 Prod Reg No. 255th meeting.
Product 57.279 date of
License Holder Indication: Balance fee issuance 16th Condition of a. Gen.
Address October, 2013. inspection abroad Iftikhar,
Non-Hodgkin’s Nil Issued by as per import CMH,

Laboratorio Lymphoma anmat policy. Rawalpindi.
ELEA Chronic Argentina.
S.A.C.I.F.y.A.. Lymphocytic
Sanabria No Leukemia Pharm ADN b. Dr. Humera
2353 Rhematoid GMP Mehmood,
C1417AZE Arthritis Certificate No. Consultant
Ciudad Granulomatosis 20132014 of
Oncolologis
Autonoma de with Polyangitis 000791 14
t NORI,
Buenos Aires, (previously dated 09-6-
Islamabad.
Republica termed wegner’s 2014
argentina Granulomatosis) c. Dr. Saleem
and microscopic SINERGIUM Siddique,
API polyangitis. BIOITECH Shifa
Manufacturing S.A. Internationa
Site: GMP l,
Pharm ADN Certificate No. Islamabad.
Carlos Villate 20132014
5148, Buenos 001894 14
aires, Argentina dated 14-2-
2015
Finished Documents
Manufacturing Legalized and
& Packaging notarized.
site:
SINERGIUM
BIOITECH
S.A.
Ruta 9km 38.7
– Grain – Prov.
De, Buenos
Aires,
Republica
argentina
24. The Searle TUXIMAB 09 -6-2015 COPP letter Valid and Deferred for
Company Ltd Injection No. legalized COPP/ submission
First floor 500mg/50ml Fee Deposited 20132019 FSC along with valid legalized
NICL Building 000142 15 GMP Certificate COPP and
Abbasi Each vial Rs.100000/- vide dated 17-4- need to be
expert opinion
Shaheed Road , contain challan No. 2015 submitted as per
of following:
Karachi 75530 500mg/50ml of 0233077 dated 18-5- above decision of
Rituximab 2015 Prod Reg No. 255th meeting.
Product 57. 279 dated
License Holder Balance fee 16-10-2013 Condition of a. Gen.

Address Indication: Issued by inspection abroad Iftikhar,
Nil anmat as per import CMH,
Laboratorio Non-Hodgkin’s Argentina. policy. Rawalpindi.
ELEA Lymphoma
S.A.C.I.F.y.A.. Chronic
Sanabria No Lymphocytic b. Dr. Humera
2353 Leukemia Pharm ADN Mehmood,
Consultant
C1417AZE Rhematoid GMP
of
Ciudad Arthritis Certificate No.
Oncolologis
Autonoma de Granulomatosis 20132014
t NORI,
Buenos Aires, with Polyangitis 000791 14 Islamabad.
Republica (previously dated 09-6-
argentina termed wegner’s 2014 c. Dr. Saleem
Granulomatosis) Siddique,
API and microscopic SINERGIUM Shifa
Manufacturing polyangitis. BIOITECH Internationa
Site: S.A. l,
Pharm ADN GMP Islamabad.
Carlos Villate Certificate No.
5148, Buenos 20132014
aires, argentina 001894 14
dated 14-2-
2015
Finished
Manufacturing Documents
& Packaging Legalized and
site: notarized.
SINERGIUM
BIOITECH
S.A.
Ruta 9km 38.7
– Grain – Prov.
De, Buenos
Aires,
Republica
argentina
25. M/s Hakimsons Sterilezed water Form 5-A Legalized Valid and Approved as
(Impex) Pt Ltd for Injection for COPP NO. legalized COPP/ diluent for
Karachi VaxiRab-N Dy No. 768 Dir DD- FSC along with exclusive use of
(Purified Chick (BD) dated 24-12-2- 449/1/D/2011 GMP Certificate VaxiRab-N
M/s Embryo Cell 13 valid upto 29- need to be
vaccine and as
SOVEREIGN Culture Rabies 11-2013 submitted as per
per Import
PHARMA Vaccine. Fee deposited submitted above decision of
PVT.LTD, S Rs.50000/- dated 255th meeting.
Policy for

urvey no.46/1- Each 1ml Vial 29-10-2013 + finished drugs.
4, Kadaiya water for Inj 50000/- dt 12-12- Condition of
Village nanai 2014 inspection abroad The firm will
Daman-396210 Diulent as per import provide valid
India Unit price: Free of policy. legalized COPP
Shelf life 05year Cost and Chairman
Registration
Board will
allow the
issuance of
registration
letter.
Case No. 02: Cases of imported veterinary biological drugs from non reference countries
Sr. Name of Brand Name & Type of Form Document Remarks Decision
No Importer & Composition details (CoPP)
Manufacturer Dy No & Date of
application Me too
status/New
Fee submitted
molecule
Pack size/ Price
1. M/s Al-Asar MYVAC IBD Form-5A Legalized Free Condition of Approved as per
Enterprise, V877 Sale certificate inspection Import Policy for
Multan (Infectious Bursal Dy. No. 1916 dated dated 23-12- abroad as per finished drugs
Disease V877 24-05-16 2015 import policy. and valid
Malaysian vaccine) legalized COPP.
Vaccines and Fee Rs. 100000/- Legalized GMP
Pharmaceutica Each dose dated 24-05-16 dated 27-09-
ls, Lot 11182, contains: 2020
Batu 20 Jalan Infectious Decontrolled/ 1000
Puchong, bronchitis virus doses per vial, 10 vials Me too
Kajang, Pulau strain V877 per pack
Meranti, Off ……..10 EID 50
2.5
Cyberjaya Active
47100 immunization of
Puchong chickens against
Selangor, IBD
Malaysia.
Shelf life: 2 years
Route of Adm:
oral via drinking

water, Intraocular
and Intranasal
2. M/s Al-Asar MyVAC NDV Form-5A Legalized Free Condition of Approved as per
Enterprise, 4HR Sale certificate inspection Import Policy for
Multan (New Castle Dy. No. 2583 dated dated 23-12- abroad as per finished drugs
Disease Vaccine) 13-06-16 2015 import policy. and valid
Malaysian legalized COPP.
Vaccines and Each dose Fee Rs.100000/- Legalized GMP
Pharmaceutica contains: dated 13-06-2016 dated 27-09-
ls, Lot 11182, New castle 2020
Batu 20 Jalan disease V4 Heat Decontrolled/ 1000
Puchong, resistant virus doses per vial, 10 vials Me too
Kajang, Pulau strain………106.0 per pack
Meranti, Off EID 50
Cyberjaya
47100 Active
Puchong immunization of
Selangor, chickens anew
Malaysia. castle disease
virus
Shelf life: 2 years

Route of Adm:
oral via drinking
water, Intraocular
and Intranasal
3. M/s Al-Asar MyVAC Fowl Form-5A Legalized Free Condition of Approved as per
Enterprise, Pox Sale certificate inspection Import Policy for
Multan (Beaudette strain Dy. No. 2582 dated dated 23-12- abroad as per finished drugs
vaccine) 13-06-16 2015 import policy. and valid
Malaysian Each dose legalized COPP.
Vaccines and contains: Rs.100000/- Legalized GMP
Pharmaceutica Fowl Pox live dated 13-06-2016 dated 27-09-
ls, Lot 11182, virus Beaudette 2020
Batu 20 Jalan Strain………102.6 Decontrolled/ 1000
Puchong, EID 50 doses per vial, 10 vials Me too
Kajang, Pulau per pack
Meranti, Off Active
Cyberjaya immunization of
47100 chickens against
Puchong fowl pox
Selangor, Shelf life: 2 years
Malaysia. Route of Adm:
wing web,

intraocular,
Intramuscular
4. M/s Al-Asar IBD UPM93 Form-5A Legalized Free Condition of Approved as per
Enterprise, (Infectious Bursal Sale certificate inspection Import Policy for
Multan Disease Vaccine) Dy. No. 2581 dated dated 23-12- abroad as per finished drugs
13-06-16 2015 import policy. and valid
Malaysian Each dose legalized COPP.
Vaccines and contains: Fee Rs.100000/- Legalized GMP
Pharmaceutica IBD Live virus dated 13-06-2016 dated 27-09-
ls, Lot 11182, strain UPM 93 2020
Batu 20 Jalan ………102.5 EID Decontrolled/ 1000
Puchong, 50 doses per vial, 10 vials Me too
Kajang, Pulau per pack
Meranti, Off Active
Cyberjaya immunization
47100 against IBD in
Puchong broilers and layer
Selangor, chickens
Malaysia.
Route of Adm:
Drinking water,
eye drop route
Shelf life: two
years
5. M/s Al-Asar MYVAC ND Form-5A Legalized Free Condition of Approved as per
Enterprise, EMULSION Sale certificate inspection Import Policy for
Multan Dy. No. 1915 dated dated 23-12- abroad as per finished drugs
(Inactivated oil
24-05-16 2015 import policy. and valid
adjuvant
Malaysian legalized COPP.
Newcastle
Vaccines and Fee Rs.100000/- Legalized GMP
disease vaccine
Pharmaceutica dated 13-06-2016 dated 27-09-
B1 Type LaSota)
ls, Lot 11182, 2020
Batu 20 Jalan Each dose Decontrolled/ 1000
Puchong, contains: doses per vial, 10 vials Me too
Kajang, Pulau New castle per pack
Meranti, Off disease virus
Cyberjaya LaSota strain ≥
47100 108.5 EID 50
Puchong Active
Selangor, immunization
Malaysia. against new
castle disease
Shelf life: 2 years

Route of Adm:
SC/ IM
6. M/s Al-Asar MYVAC 102 Form-5A Legalized Free Condition of Approved as per
Enterprise, Sale certificate inspection Import Policy for
Multan (New castle Dy. No. 1917 dated dated 23-12- abroad as per finished drugs
disease B1 type 24-05-16 2015 import policy. and valid
Malaysian LaSota Strain) legalized COPP.
Vaccines and Fee Rs.100000/- Legalized GMP
Pharmaceutica Each dose dated 13-06-2016 dated 27-09-
ls, Lot 11182, contains: 2020
Batu 20 Jalan New castle Decontrolled/ 1000
Puchong, disease virus doses per vial, 10 vials Me too
Kajang, Pulau LaSota per pack
Meranti, Off strain:…… 10 5.5
Cyberjaya EID 50
47100
Puchong Active
Selangor, immunization
Malaysia. against new
castle disease
Shelf life: 2 years

Route of Adm:
oral route,
intraocular route
and intranasal
7. M/s Al-Asar MYVAC 202 Form-5A Legalized Free Condition of Approved as per
Enterprise, (Combined New Sale certificate inspection Import Policy for
Multan castle disease & Dy. No. 1917 dated dated 23-12- abroad as per finished drugs
Infectious 24-05-16 2015 import policy. and valid
Malaysian bronchitis legalized COPP.
Vaccines and vaccine) Fee Rs.100000/- Legalized GMP
Pharmaceutica dated 13-06-2016 dated 27-09-
ls, Lot 11182, Each dose 2020
Batu 20 Jalan contains: Decontrolled/ 1000
Puchong, doses per vial, 10 vials Me too
Kajang, Pulau New castle per pack
Meranti, Off disease virus B1
Cyberjaya Type, LaSota
47100 strain… 105.5 EID
Puchong 50
Selangor, Infectious
Malaysia. bronchitis virus

Massachusetts
type H120
strain…. 103.1
EID 50
Active
immunization
against ND and
IBD
Shelf life: 2 years

Route of Adm:
oral route,
intraocular route
and intranasal
8. Hospital QYH-ND IB 22-Dec-10 Legalized Free Condition of Deferred for
Services & EDS Sale Certificate inspection confirmation of
Sales 13-C (Newcastle Deposited fee No. (2011) abroad as per local availability/
Annexe, Block Disease, 100000/- 160132129 import policy. approval of
6, P.E.C.H.S, Infectious Dated 01-06- similar vaccine.
Shahrah-e- Bronchitis & Egg Balance Fee 2013
Faisal, Karachi Drop Syndrome Nil
75400. Vaccine, Legalized
Inactivated) CoPP No. 3
Parent Pack Sizes: Dated 10-12-
Company/Lic. Each one dose (250mL / Bottle) 2015
Holder: contains:-
QYH Biotech Inactivated Product
Company Newcastle License No.
Ltd., Disease virus La (2010) 01008
Building. No. Sota strain (the Dated 09-03-
20, Part 11, virus titer is ≥ 2010
ABP, No. 188, 3x108.0EID50/
Southwest 4th0.1ml before Legalized GMP
Ring Road, Certificate No.
inactivation),
Fengtai (2014) 220
District, inactivated Dated 16-10-
Infectious
Beijing, China. 2014
Bronchitis
Manufacturin virus M41
g Site: strain (the
Zhengzhou
Bio-
virus titer is ≥
6.0
Pharmaceutic 3x10 EID50/

al Factory of 0.1ml before
QYH Biotech inactivation)
Co. Ltd.,
and inactivated
Shibalihe,
South Surburb, Egg Drop
Zhengzhou Syndrome
City, Henan virus AV127
Provice, P. R. strain (the HA
China.
titer of the
virus is ≥
1:30720 before
inactivation),
(For Veterinary
Use)
9. Tarobina Bovishot® Form-5(A) Legalized FSC Condition of Deferred for
Corporatin , Ephemer dated 26-6- inspection expert opinion
New Garden (Bovine Dy No. 4913 (R&I) 2015. abroad as per pertaining to
Town, Lahore ephemeral fever DRAP dated 05-8- import policy. prevelance,
virus live 2015 Legalized GMP epidemiology,
vaccine) Certificate domestic
Choong Ang Fee deposited dated 22-5- requirement etc.
Vaccine Composition per Rs. 100000/- dated 2015
Laboratories dose (2.0ml/dose) 03-8-2015 from following:
co., Ltd. 1476- Bovine a. Dr. Qurban
37 Yuseong- ephemeral fever Dosage: Ali, NVL,
daero, virus….≥ 3doses/bottle Islambad
Yuseong-gu, 103.0TCID50/dose b. Dr. Masood
daejeon, Korea Stablizer…50% Maximum Retail Rabbani,
305-348 Price: Rs. 2115/- UVAS,
Lahore.
Uses: For control
c. Dr. Arif
and preventin of Awan,
bovine ephemeral CASVAB
fever caused by Quetta.
BEFV in cows.
Shelf life:
Twelve(12)
months
Route:
Subcutanously
Injection

(For Veterinary
Use)
10. M/s Vetline ITA ND + IB Form 5-A Copy of GMP Legalized As the firm has
International , (Inactivated Certificate No. valid Free sale provided valid
Lahore, Injectable Dy No. 1497 R&I CG- certificate legalized FSC
Pakistan emulsion Vaccine DRAP dated 05-5- HU/09V/2014 along with ((02.2/3442-2/
for active 2016. GMP/ CoPP is 2016 dated 10-
CEVA- Immunization of DML No. MA- required. 06-2016) and
PHYLAXIA chickens against Fee deposited Rs. HU/04V/2009/ GMP certificate
Veterinary Newcastle 100000/- dated 02-5- M1. Dated 04- (02.2/3442-5/
Biologicals disease (ND) and 2016 11-2014 2016 dated 10-
Co. Ltd., infectious Hungary. 06-2016) and
Horog u. 32- Bronchitis (IB). Registration
34. 1107 Board considerd
Budapaest -50 pd50 of the documents
HUNGARY Inactivated and approved the
Newcastle product as per
disease Virus, Import Policy for
strain LaSota. finised drugs.
-induced min . 6
log2 HI, of
Inactivated
Infectious
bronchitis virus,
strain
Pharmacologial
group: Avian
inactivated
vaccine
Route
administratin:
Subcutaneously
or
Intramuscularly
Uses: Vaccine is
recommended for
the vaccination of
breeder and lying
type chikens
flocks, previously
immunization

against
Newcastle
disease and
infectious
bronchitis with
attenuated live
virus vaccine.
11. M/s Vetline ITA CORYZA Form 5-A GMP Legalized As the firm has
International , ABC Gel Certificate No. valid Free sale provided valid
Lahore, (Inactivated Dy No. 1495 R&I CG- certificate legalized FSC
Pakistan Aluminium DRAP dated 05-5- HU/09V/2014 along with ((02.2/3442-3/
Hydrooxide 2016 GMP/ CoPP is 2016 dated 10-
CEVA- suspension DML No. MA- required. 06-2016) and
PHYLAXIA Vaccine for the Fee deposited: HU/04V/2009/ GMP certificate
Veterinary immunization of Rs.100000/- dated 02- M1. Dated 04- (02.2/3442-5/
Biologicals chickens against 5-2016 11-2014 2016 dated 10-
Co. Ltd., infectious Hungary 06-2016) and
Horog u. 32- Coryza. Packs: One dose of Registration
34. 1107 0.5ml Board considerd
Budapaest Composition: the documents
HUNGARY Active and approved the
substances: product as per
Inactivated Import Policy for
antigens: finised drugs.
Avibacterium
paragallinarum
serotypeA……mi
n. 7 log 10 CFU*
before
inactivation
Avibacterium
paragallinarum
serotype B……
min. 7 log 10
CFU* before
inactivation
Avibacterium
paragallinarum
serotype C……
min. 7 log 10
CFU* before
inactivation.

*CFU – colony
forming unit
Pharmacological
group:
Biologicals –
Avian inactivate
vaccine.
Route of
administration:
one dose of 0.5ml
injected
subcutaneously
or
intramuscularly
Uses: ITA
CORYZA ABC
Gel is
recommended for
vaccinatin f
breeder and
laying type of
chicken flocks
against infectious
Coryza caused by
Avibacterium
paragallinarum
infection in order
to reduce the
clinical signs and
lesions of
diseases.
12. M/s Marush CEVAC Form 5-A Legalized FSC Approved as per
Limited, Transmune No.02.2/729- Import Policy for
Lahore Dy No. 271 R&I 21/2016 dated finished drugs
(Live freeze dried DRAP dated 13.5.16 08-2-2016 and as per valid
CEVA complex vaccine, legalized COPP.
PHYLAXIA, (winterfield 2512 Fee deposited: Legalized GMP
Veterinary G-61 strain IBD Rs.100000/- dated 11- No.02.2/729-
Biological, Co. antibidoes) 5-2016 21/2016 dated
Ltd 110 7 08-2-2016.
budapest Each dose Packs: 2000. 4000,

Szallas u 5 contains: 8000 doses.
Hungary. Avian infectious
bursal disease
virus strain
winterfield 2512,
G-61……min 0.1
CID 50
Immunization of
healthy chicjens
against IBD
Route of adm: SC
Shelf life: 24
months
Case No.03: Cases of Veterinary Biological Vaccines / Drugs for Local

Manufacturing.
S.#. Company Brand name Date of International Remarks Decision

name and /Drug application/ availability
name of Composition Fee status/ / Me too status
manufacturer packs
1. M/s Grand GPVAC ND (A) Form-5 Local Deferred for
Pharma (Pvt) Injection manufacturing of products
Ltd, Rawat, Newcastle Disease Dy No. 567 veterinary specification
inspection
Islamabad Vaccine ADC(BD) vaccine. In the
by following
(Local Each dose of 0.30 dated 23-5- 254th RB Meeting experts:
Manufacturer) ml contains: 2016 on the similar
Inactivated case the Board a. Dr.
Newcastle Disease Fee deposited decided for Muham
Virus….Inducing≥ Rs.20000/- product specific mad
4.5 log2 HI uits dated 20-5- inspection by Arshad,
Member
2016 experts focusing
Registrat
Uses: on processs, ion
For the precention Price : strain status, Board
of Newcastle Decontrolled safety and
Disease in poultry potency data. b. DDG
for facster Packs 250ml, Biologic
production of 300ml,500ml al),
DRAP
antibodies ,600ml
c. Area

Shelflife: one year FID,
DRAP
2. M/s Grand GPVAC H-9 Form-5 Local Deferred for

Pharma (Pvt) Shield Injection manufacturing of products
Ltd, Rawat, Dy No.562 veterinary specification
inspection by
Islamabad Avian Influenza ADC (BD) vaccine. In the
following
(Local H9 cloned vaccine dated 23-5- 254th RB Meeting experts:
Manufacturer) Each ml (1000 2016 on the similar
doses0 contains; case the Board a. Dr.
Live rHVT-H9 Fee deposited decided for Muham
virus…..3x106 Rs. 20000/- product specific mad
plaque-forming dated 20-5- inspection by Arshad,
Member
units (pfu) 2016 experts focusing
Registrat
Dosage: 3x103 fpu on processs, ion
per bird Price: strain status, Board
Decontrolled safety and b. DDG
Shelf life: Two potency data. Biologic
years Packs, al)
1000,2000,40 c. Area
FID,
Uses: For the 00,5000
DRAP
prevention against doses
avian influenza
virus serotype H9
and Marek’s
disease virus
serotype-3 in
broilers.
3. M/s Grand GPVAC Form-5 Local Deferred for
Pharma (Pvt) ND+IB+H9 manufacturing of products
Ltd, Rawat, Injection Dy No. 563 veterinary specification
inspection by
Islamabad Combined ADC (BD) vaccine. In the
following
(Local Newcastle disease, dated 23-5- 254th RB Meeting experts:
Manufacturer) Infectious 2016 on the similar
bronchitis and case the Board a. Dr.
avian influenza H9 decided for Muham
vaccine Fee deposited product specific mad
Each dose of Rs. 20000/- inspection by Arshad,
Member
0.30ml contains: dated 20-5- experts focusing
Registrat
Inactivated 2016 on processs, ion
Newcastle disease strain status, Board
virus….inducing Price : safety and b. DDG
5 log2 HI Decontrolled potency data. Biologic
al)

units/dose c. Area
Packs 250ml, FID,
Infectious 300ml,500ml DRAP
bronchitis virus , 600ml
(Mass
strain)….inducing
5 log2 HI
units/dose
Inactivated Avian
Influenza virus
H9….inducing5
log2 HI units/dose.
Shelf life: Two

years
4. M/s Grand GPVAC ND- Form – 5 Local Deferred for

Pharma (Pvt) Kaseef Injection Dy No. 564 manufacturing of products
Ltd, Rawat, New castle ADC (BD) veterinary specification
inspection by
Islamabad Disease Vaccine dated 23-5- vaccine. In the
following
(Local Each dose of 2016 254th RB Meeting experts:
Manufacturer) 0.20ml contains: on the similar
Inactivated Fee deposited case the Board a. Dr.
Newcastle Disease Rs. 20000/- decided for Muham
Virus…Inducing dated 20-5- product specific mad
4.5 log2 HI units 2016 inspection by Arshad,
Member
experts focusing
Registrat
Shelf life: Two Price: on processs, ion
years Decontrolled strain status, Board
safety and
b. DDG
Packs 250ml, potency data. Biologic
300ml,500ml al)
,600ml c. Area
FID,
DRAP
5. M/s Grand GPVAC POLY- Form – 5 Local Deferred for
Pharma (Pvt) FLU Injection manufacturing of products
Ltd, Rawat, Avian Influenza Dy No. 565 veterinary specification
inspection by
Islamabad polyvalent vaccine ADC (BD) vaccine. In the
following
(Local Each dose of dated 23-5- 254th RB Meeting experts:
Manufacturer) 0.30ml contains: 2016 on the similar
case the Board a. Dr.
Inactivated Avian decided for Muham
Influenza type Fee deposited product specific mad

H5….Inducing5 Rs. 20000/- inspection by Arshad,
log2 HI units/dose dated 20-5- experts focusing Member
2016 on processs, Registrat
ion
Inactivated Avian strain status,
Board
Influenza type Price: safety and b. DDG
H7….inducing5 Decontrolled potency data. Biologic
log2 HI units/dose al)
Packs 250ml, c. Area
Inactivated Avian 300ml,500ml FID,
,600ml DRAP
Influenza virus
H9….inducing5
log2 HI units/dose.
Shelf Life: Two

years
6. M/s Grand GPVAC Hydro- Form – 5 Local Deferred for

Pharma (Pvt) TC Plus Injection manufacturing of products
Ltd, Rawat, Bivalent HPS-IBH Dy No. 561 veterinary specification
inspection by
Islamabad vaccine ADC (BD) vaccine. In the
following
(Local Each 0.30 ml dose dated 23-5- 254th RB Meeting experts:
Manufacturer) contains: 2016 on the similar
case the Board a. Dr.
Inactivated Avian decided for Muham
Adenovirus Fee deposited product specific mad
serotype-4….7 Rs. 20000/- inspection by Arshad,
Member
log10 EID50/dose dated 20-5- experts focusing
Registrat
2016 on processs, ion
Inactivated Avian strain status, Board
Adenovirus Price: safety and b. DDG
serotype-8….7 Decontrolled potency data. Biologic
log10 EID50/dose. al)
Packs 250ml, c. Area
FID,
Shelf life: Two 300ml,500ml
DRAP
years ,600ml
7. M/s Grand GPVAC MG- Form – 5 Local Deferred for
Pharma (Pvt) Bacterin Injection manufacturing of products
Ltd, Rawat, Mycoplasma Dy No. 566 veterinary specification
inspection by
Islamabad gallisepticum ADC (BD) vaccine. In the
following
(Local vaccine dated 23-5- 254th RB Meeting experts:
Manufacturer) Each ml contains: 2016 on the similar
Mycoplasma case the Board a. Dr.
gallisepticum…… decided for Muham
5 x 107 CFU/ml Fee deposited product specific mad

Rs. 20000/- inspection by Arshad,
Shelf life: Two dated 20-5- experts focusing Member
years 2016 on processs, Registrat
ion
strain status,
Board
Uses: For the Price: safety and b. DDG
prevention of Decontrolled potency data. Biologic
mycoplasma al)
gallisepticmum in Packs 250ml, c. Area
poultry. 300ml,500ml FID,
,600ml DRAP
8. M/s Grand GPVAC FLU 7+9 Form – 5 Local Deferred for
Pharma (Pvt) (A) Injection manufacturing of products
Ltd, Rawat, Avian Influenza Dy No. 568 veterinary specification
inspection by
Islamabad virus H7+N9 ADC (BD) vaccine. In the
following
(Local Aqueous vaccine dated 23-5- 254th RB Meeting experts:
Manufacturer) Each dose of 2016 on the similar
0.30ml contains: case the Board a. Dr.
Inactivated Avian Fee deposited decided for Muham
Inafluenza virus Rs. 20000/- product specific mad
H7…Inducing4.5 dated 20-5- inspection by Arshad,
Member
log2 HI units 2016 experts focusing
Registrat
on processs, ion
Inactivated Avian Price: strain status, Board
Inafluenza virus Decontrolled safety and b. DDG
H9…Inducing4.5 potency data. Biologic
log2 HI units Packs 250ml, al)
300ml,500ml c. Area
FID,
Shelf life: One ,600ml
DRAP
year
9. M/s SANNA NIAB (H.S. Form – 5 PSI is required by Deferred for
Laboratories, VACCINE) the panel of products
Faisalabad Injectable Dy No. 655 experts. specification
inspection by
(Local Formaline R&I DRAP
following
Manufacturer) inactivated dated 29-1- experts:
Pasturella 2015
muoltocida oil a. Dr.
adjuvanted Fee deposited Muham
vaccine Rs. 20000/- mad
Each dose dated 23-12- Arshad,
Member
contains: 2014
Registrat
….Inactivated oil ion
emulsified Price: Board
Pasturella Decontrolled b. DDG
multocida Biologic

Packs 30ml, al)
Proposed route: 90ml,300ml, c. Area
Subcutanous 900ml FID,
DRAP
Injection
Uses: For animals

to protect against
Heamorrhagic
Septicemia
Shelf life: 02 years

10. M/s SANNA PROMAS Form -5 PSI is required by Deferred for
Laboratories, Injectable the panel of products
Faisalabad Fee deposited experts. specification
inspection by
(Local Each ml contains Rs. 60000/-
following
Manufacturer an minimum of 6 dated 20-6- experts:
x 109 m.o of: 2013
Staphylococcus a. Dr.
aureus, Dosage: 5ml Muham
Streptococcus mad
agalactiae, Price - Arshad,
Member
Escherichia coli Decontrolled
Registrat
and ion
Arcanobacterium Board
pyogenes oil b. DDG
adjuvancted Biologic
vaccine. al)
c. Area
FID,
Uses: For
DRAP
prevention of
mastitis in cattle
buffalo, sheep,
goat and camel.
Shelf life: One

year
11. M/s SANNA ENTOMIAVAC Form -5 Deferred for

Laboratories, (Enterotoxemia products
Faisalabad Vaccine) Dy No. 472 specification
inspection by
(Local R&I, DRAP
following
Manufacturer Formaline dated 22-3- experts:
inactivated 2016
clostridium a. Dr.

perfringeens oil Fee deposited Muham
adjuvanted Rs. 20000/- mad
vaccine dated 22-3- Arshad,
Member
2016
Registrat
Each dose ion
contains: Dosage: 2ml Board
Inactivated Oil b. DDG
Emulsified Price – Biologic
Clostridium Decontrolled al)
perfringens… 1 x c. Area
FID,
109 Packs: 15ml,
DRAP
30ml ,
Shelf Life: One 300ml,
(01) Year 600ml.
Uses: For Sheep/

Goat to protect
atainst
Enterotixemia
12. M/s SANNA BQ-VAC (Black Form -5 Deferred for
Laboratories, Quarter Vaccine) products
Faisalabad Dy No. 476 specification
inspection by
(Local Formaline R&I, DRAP
following
Manufacturer Inactivated dated 22-3- experts:
Clastridium 2016
chavoei oil a. Dr.
adjuvanted Fee deposited Muham
Vaccine Rs. 20000/- mad
dated 22-3- Arshad,
Member
Each dose 2016
Registrat
contains: ion
Inactivated Oil Board
Emulsified Price – b. DDG
Clostridium Decontrolled Biologic
Chavoei.. 1 x 109 al)
Packs: 30ml, c. Area
FID,
90ml ,
DRAP
Shelf Life: One 300ml,
Year 600ml.
Uses: For large

animals to protect
against Black
Quarter

13. M/s SANNA APTHOVAC Form -5 Deferred for
Laboratories, (Foot and Mouth products
Faisalabad disease Vaccine) Dy No. 475 specification
inspection by
(Local R&I, DRAP
following
inactivate 2016
Aphthovirus oil a. Dr.
adjvanted Vaccine Fee deposited Muham
Rs. 20000/- mad
Each dose dated 22-3- Arshad,
Member
contains: 2016
Registrat
Inactivated Oil ion
Emulsified Board
Aphthovirus Price – b. DDG
Decontrolled Biologic
Shelf life: One al)
year Packs: 25ml, c. Area
FID,
50ml ,
DRAP
100ml,
200ml.
14. M/s SANNA SANTHRAX Form -5 Deferred for
Laboratories, (Anthrax Disease products
Faisalabad Vaccine) Dy No. 473 specification
inspection by
(Local R&I, DRAP
following
inactivated 2016
bacillus anthracis a. Dr.
oil adjuvanted Fee deposited Muham
Vaccine Rs. 20000/- mad
dated 22-3- Arshad,
Member
Each dose 2016
Registrat
contains: ion
Inactivated Oil Board
Emulsified Price – b. DDG
Bacillus anthracis Decontrolled Biologic
5 x109 al)
Packs: 25ml, c. Area
FID,
Shelf life: One 1250ml ,
DRAP
year 300ml,
900ml.
Uses: For large

animal to protect
against anthrax
15. M/s SANNA GALLIPRO Form -5 Deferred for

Laboratories, ND+H9 (ND & products
Faisalabad A1 H9 Disease Dy No. 474 specification
inspection by
(Local Vaccine) R&I, DRAP
following
Manufacturer dated 22-3- experts:
Formaline 2016
inactivated New a. Dr.
castle disease Fee deposited Muham
virus lasota & Rs. 20000/- mad
Influenza A Virus dated 22-3- Arshad,
Member
subtype H9 oil 2016
Registrat
ion
Each dose Board.
contains: Price –
Inactivated Oil Decontrolled b. DDG
Emulsified New Biologic
castle disease Packs: al).
virus lasota 150ml, ,
Influenza A Virus 300ml, c. Area
FID,
subtype H9 600ml. DRAP
Shelf life: One

year
Uses: For Poultry

Birds to protect
against New castle
disease and sub
strain H9 of Avian
Influenza disease
Case No.04: Local Manfacturing Of (Biological Drugs) M/S Macter International, Karachi
a. Clariclot (Recombinant streptokinase) 1.5MIU Vial of M/S Macter International

Karachi
S.No. Documents and data Documents and data submitted Remarks

required as per 246th by M/s Macter International
meeting Karachi

1. Legalized GMP certificate of Firm has submitted the legalized Valid legalized GMP
biological drug as an GMP certificate NO. is required.
evidence that the 3753/M3b/2013 dated 20-5-2013
manufacturer is an valid upto 2years from date of
authorized manufacturer of issuance of Manufactured by M/s
that particular biological Shasun Pharmaceuticals Limited
drug in its country of origin. 33&34, Shasun Road,
Periyakalapet, Puducherry –
605014, Mfg at Vijayapuri North
Nagarjunasagar Nalagonda District
India
2. Legalized COPP No. 1919-

AB(M3A) TS / 2014 valid upto 19-
5-2015 for LIFOKINASE 1.5MIU
(STREPTOKINASE INJECTION
IP)
Manufactured by M/s Shasun
Pharmaceuticals Limited 33&34,
Shasun Road, Periyakalapet,
Puducherry – 605014, Mfg at
Vijayapuri North Nagarjunasagar
Nalagonda District India
3. Structural similarity of Not provided Structural similarity
subject biological drug data is required
product (concentrate/ ready
to fill bulk for further
processing) with reference
biological product
(innovator)
4. Manufacturer to manufacture Not provided

the finished biological
product for trial studies
5. Bio-comparability studies Not provided Bio-comparability
including identity testing to study data is required.
parent molecule, purity
testing, in vitro biological
activity, potency and toxicity
with support of iso-electro
focusing data, gel
electrophoresis, Western-
Blot and other analytical
techniques) and stability

studies of finished biological
product
6. Others Specification of streptokinase No local data

bulk solution provided as under: available. Directions
 Description from RB is solicited.
 Particular Matter
 Identification test
 PH
 Bacterial endotoxin
 Assay (Activated by bioassay
 Sterility
Stability Study report
streptokinase bulk solution
provided
Finished product specifications
submitted by M/s Macter
International, Karahci are as
under:
Description, Identification, PH,

Steptodoranse, Streptolysin, Loss
on drying, Bacterial Endotoxin,
Assay (Acitivity by Bioassay),
Sterility, Clarity of solution,
Particulate Matter, Extractable
volume and Uniformity of weight.
Finished product stability

submitted by M/s Shasun
Pharmaceuticals India.
The submitted data needs to be evaluated in the light of 246th meeting of RB by panel of experts
for geniuness and accuracy.
b. Redimab (Rituximab) 100mg/10ml Vial of M/s Macter International, Karachi
Sr. Documents and data Documents and data submitted by Remarks

No required as per 246th M/s Macter International Karachi

meeting
1 Legalized GMP certificate of Legalized GMP Certificate No.

biological drug as an CN20110019 DATED 09-10-2011
evidence that the valid until 08-10-2016 M/s
manufacturer is an Shanghai CP Guojian
authorized manufacturer of Pharmaceutical co., Ltd. China.
that particular biological
drug in its country of origin.
2 Structural similarity of Charactrization of Primanry and

subject biological drug secrondary structure of redimab and
product (concentrate/ ready its comparability analysis with
to fill bulk for further innovator retuximab sold under
processing) with reference brand name of Rituxan by M/s
biological product Shanghai CP Guojian
(innovator) Pharmaceutical co., Ltd. China
following methods:
 N-terminal amino acid

sequenced analysis,
 C-terminal Lys truncation by
mass peptide maping by
sequence coverage.
 Molecule weight by reducing
SDS PAGE.
 MALDI-TOF Mass spectrum
performed the test results
demonstrate that the main
components of basically
identical, and the molecular
weight of relative to each other
 Peptide Mapping by RP-HPLC
which demosntrates that our
products are homogeneioujs and
stable.
 Comparison of Methionine
Oxidation for Anti-CD20
innovator.
 Biological Charatarization was
done by biocactivity
determination and affinity
comparison by
immumofluorescence method.
 Inpurities by SEC-HPLC, SDS-
PAGE


3 Manufacturer to manufacture
4 Bio-comparability studies Comparitive analysis of finished

including identity testing to drug (Redimab) with Ristova of
parent molecule, purity Roche:
testing, in vitro biological Identity by SDS Page
activity, potency and toxicity Purity:
with support of iso-electro SDS Page (Silver staining)
focusing data, gel Gel Filteration HPLC
electrophoresis, Western- Protein content by UV (280nm)
Blot and other analytical Biological activity
techniques) and stability General safety tests :
studies of finished biological BET and sterlity
product
5 Others Certificateof analyisis of Rituximab

bulk is submitted.
Stability data of finished product
(accelerated and real time ) is
provided.
Clinical Data has also been
submitted.
c. Redimab (Rituximab) 500mg/50ml Vial of M/s Macter International, Karachi

meeting
1 Legalized GMP certificate of Copy of GMP Certificate No.
biological drug as an CN20110019 DATED 09-10-2011
evidence that the valid until 08-10-2016 sumbitted.
manufacturer is an
authorized manufacturer of
subject biological drug secrondary structure of redimab and
product (concentrate/ ready its comparability analysis with
to fill bulk for further innovator retuximab sold under

processing) with reference brand name of Rituxan by M/s
biological product Shanghai CP Guojian
(innovator) Pharmaceutical co., Ltd. China
following methods:
 N-terminal amino acid
sequenced analysis,
 C-terminal Lys truncation by
mass peptide maping by
sequence coverage.
 Molecule weight by reducing
SDS PAGE.
weight of relative to each other
stable.
 Comparison of Methionine
Oxidation for Anti-CD20
innovator.
comparison by
PAGE
4 Bio-comparability studies Comparitive analysis of finished
including identity testing to drug (Redimab) with Ristova of
parent molecule, purity Roche:
testing, in vitro biological Identity by SDS Page
activity, potency and toxicity Purity:
with support of iso-electro SDS Page (Silver staining)
focusing data, gel Gel Filteration HPLC
electrophoresis, Western- Protein content by UV (280nm)
Blot and other analytical Biological activity
techniques) and stability General safety tests :
studies of finished biological BET and sterlity
product
5 Others Certificateof analyisis of Rituximab

bulk is submitted.
(accelerated and real time) is
provided.
Clinical Data has also been
submitted.
d. EPOCAN Injection (Epoetin alpha 2000IU/ml., 4000IU/ml and 10000IU/ml) Vial of M/s
Macter International, Karachi

meeting
1 Legalized GMP certificate of Legalized GMP Certificate No. GMP submitted
biological drug as an CN20140140 date of issuance 17-3- reflects that
evidence that the 2014 valid upto 16-03-2019 M/s manufacturer is
manufacturer is an Shandong Kexing Bio – Products authorize to
authorized manufacturer of co., Ltd. Tangwangshan Road, manufacturer
that particular biological Mingshui Development Zone, Recombinant Human
drug in its country of origin. Zhangqiu, Shandong, China Erythropoietin
submitted. injection.
2 Legalized Free Sale Certificate No.
2015-157 date of issuance 16-11-
2015 valid for two year for date of
issuance for Erythropoietin injection
submitted.
Legalized COPP No. WHO. CPP-
CERT-ZQ-151116 date of issuance
16-11-2015
3 Structural similarity of Not provided Only comparative
subject biological drug studies conducted
product (concentrate/ ready locally is submitted
to fill bulk for further
biological product
(innovator)
5 Bio-comparability studies Comparative analysis of
including identity testing to Recombinant Human

parent molecule, purity Erythropoietin Vs RMP
testing, in vitro biological Recormon Roche is submitted
activity, potency and toxicity and following test are carried out
with support of iso-electro by M/s Macter International,
focusing data, gel Karachi
electrophoresis, Western-  SDS-PAGE (Silver staining)
Blot and other analytical  Isoelectric focusing
techniques) and stability  Purity( By Gel filtration
studies of finished biological chromatography)
product  Sialic Acid (by Resorcinol
Method)
 Protein content (By ELISA)
Comparitive analysis of Finished

product VS BRP Erythropoetin
Alfa EDQM is also submitted
and following test are carried out:
Identity by ELISA, Potency by

Elisa, Total Protein content (By
Lowry Assay), General Safety Test
(By Bacterial endotixin test by gel
Clot Method (LAL Test), Sterility
Test by membrane filtration
method.
6 Others Specification of ready to filled
bulk of M/s Shandong Kexing
bioproducts Co., Ltd, China
Identification test, Physical tests
(Appearance Visible particles),
Chemical tests (pH, Content of
sodium ion content of citrate ion
content of protein Osmolality,
Activity tests (Activity in vitro ,
Activity in vivo), Sterility and BET
, Abnormal toxicity test.
Finished products specification of

M/s Macter International Karachi
as under:
Physical Appearance,
ParticulateMater, Extractable
volume, pH, Osmaolality, Immuno-
identification, Potency, Content of

Protein, BET, Sterility, Abnormal
Toxicity.
The firm has also submitted

accelerated and real time stability
studies
e. T-Mab (Trastuzumab) 150mg Vial of M/s Macter International, Karachi

meeting
1 Legalized GMP certificate of Legalized GMP Certificate No.
biological drug as an CN20110019 dated 09-10-2011
evidence that the valid until 08-10-2016 M/s
manufacturer is an Shanghai CP Guojian
authorized manufacturer of Pharmaceutical co., Ltd. China.
subject biological drug secondary structure of anti-HER2
product (concentrate/ ready rh.MAb and its comparability
to fill bulk for further analysis with innovator Herceptin
processing) with reference by M/s Shanghai CP Guojian
biological product Pharmaceutical co., Ltd. China
(innovator) following methods:
 The pimary structure of anti-
HER2 rhMAb. Similarity in
secondary sturucture by circular
dichroism (CD) and Spectra.
 Similarity in IEF profile.
 Similarity in molecular weight
by reducing SDS-PAGE.
weight of relative to each other.
stable.

 N-Glycosylation Analtysis.
 Similarity in Biological
Activities and Immunological
Properties

comparison by
PAGE
4 Bio-comparability studies Biocomparability of finished drug
including identity testing to the firm has submitted following
parent molecule, purity data are as under:
activity, potency and toxicity Comparative Analysis of Locally
with support of iso-electro Manufactured Drug Product of T-
focusing data, gel Mab 150 mg with Reference
electrophoresis, Western- Medicinal Product Harceptin,
Blot and other analytical Materials, Indentificatin (BySDS-
techniques) and stability PAGE), Purity (By SDS-PAGE),
studies of finished biological Reiative Potency (By ELISA),
product General Safety Tests (By Bacterial
Endotoxin Test) (By Sterility Test)
(By Abnormal Toxicity Test) (By
Abnormal Toxicity Test).
Stability Studies of Locally
Manufactured Drug Product of T-
Mab 15mg with Reference
Medicinal Product Harceptin.
Real Time stability studies,
Accelerated stability studies
5 Others Animal Toxicology study The firm
submitted data are as under:
1. Pharmacology
(Primary pharmacology, Secondary
Pharmacology, Safety
Pharmacology, Pharmacodynamic
drug interactions).
2. Pharmacokinatics
(Absorption, distribution,

Metabolism, Excretion,
Pharmacokinetics Drug Interaction)
3. Single-Dose Toxicity
(Acute Single-Dose toxicity for
intravenous injection anti-HER2 rh
MAB of CPGJ into mice)
4. Repeat-Dose toxicity
(Repeat-Dose toxicity for
MAB of CPGJ into rhesus)
5. Genotoxicity
(Genotoxicity of –HER2 rh MAB of
CPGJ)
6. Hepolytic Study
(Hemolytic Study of –HER2 rh
MAB of CPGJ)
f. T-Mab (Trastuzumab) 440mg Vial of M/s Macter International, Karachi

meeting
1 Legalized GMP certificate of Legalized GMP Certificate No. The application of the
biological drug as an CN20110019 dated 09-10-2011 firm is consider in
evidence that the valid until 08-10-2016 M/s 257th meeting of RB
manufacturer is an Shanghai CP Guojian wherein it was
authorized manufacturer of Pharmaceutical co., Ltd. China deferred for
that particular biological evaluation by the
drug in its country of origin. division.
subject biological drug secondary structure of anti-HER2
product (concentrate/ ready rh.MAb and its comparability
to fill bulk for further analysis with innovator Herceptin
processing) with reference by M/s Shanghai CP Guojian
biological product Pharmaceutical co., Ltd. China
(innovator) following methods:
 The pimary structure of anti-
HER2 rhMAb. Similarity in
secondary sturucture by circular
dichroism (CD) and Spectra.

 Similarity in IEF profile.
 Similarity in molecular weight
by reducing SDS-PAGE.
weight of relative to each other.
stable.
 N-Glycosylation Analtysis.
 Similarity in Biological
Activities and Immunological
Properties
comparison by
PAGE
4 Bio-comparability studies Biocomparability of finished drug

including identity testing to the firm has submitted following
parent molecule, purity data are as under:
activity, potency and toxicity Comparative Analysis of Locally
with support of iso-electro Manufactured Drug Product of T-
focusing data, gel Mab 15mg WITH Reference
electrophoresis, Western- Medicinal Product Harceptin,
Blot and other analytical Materials, Indentificatin (BySDS-
techniques) and stability PAGE), Purity (By SDS-PAGE),
studies of finished biological Reiative Potency (By ELISA),
product General Safety Tests (By Bacterial
Endotoxin Test) (By Sterility Test)
(By Abnormal Toxicity Test) (By
Abnormal Toxicity Test).
Stability Studies of Locally

Manufactured Drug Product of T-
Mab 15mg with Reference

Medicinal Product Harceptin.
Real Time stability studies,
Accelerated stability studies
5 Others Animal Toxicology study The firm

submitted data are as under:
1. Pharmacology
(Primary pharmacology, Secondary
Pharmacology, Safety
Pharmacology, Pharmacodynamic
drug interactions).
2. Pharmacokinatics
(Absorption, distribution,
Metabolism, Excretion,
Pharmacokinetics Drug Interaction)
3. Single-Dose Toxicity
(Acute Single-Dose toxicity for
MAB of CPGJ into mice)
4. Repeat-Dose toxicity
(Repeat-Dose toxicity for
MAB of CPGJ into rhesus)
5. Genotoxicity
(Genotoxicity of –HER2 rh MAB of
CPGJ)
6. Hepolytic Study
(Hemolytic Study of –HER2 rh
MAB of CPGJ)
g. Macgrastim (Filgrastim (rhGCSF) 300mcg/ 1.2 ml) vial.

meeting
1 Legalized GMP certificate of Legalized CoPP No: CN20130269
biological drug as an dated 30.09.2013 valid upto
evidence that the 29.09.2018 of M/s Hangzhou
manufacturer is an Jiuyuan Gene Engeineering Co.,

authorized manufacturer of Ltd, China indication that the
that particular biological manufacturer has approval to
drug in its country of origin. manufacture the rhGCSF injection
2 Structural similarity of Physicichemical and biosililarity

subject biological drug analysis of rhGSCF with Filgratim
product (concentrate/ ready produced by Kirin Brewery Co.,
to fill bulk for further Japan:
processing) with reference rhGSCF Formula/ chemical
biological product structure.
(innovator)  Molecular weight:
SDS reducing Page
HPLC
 Purity:
Gel electrophoresis
Isoelecric focusing
RP HPLC
SEC HPLC
Capillary electrophoresis
 Assay for chemical structure:
Sequencung of rDNA
UV spectrum
Composition of amino acids
Pepetide mapping
N- terminal sequencing
 Immunology:
Identification by wetstern
blot
ELISA
 Bilogical activity.
4 Bio-comparability studies
Comparative Analysis of Locally
including identity testing to
Manufactured Product
testing, in vitro biological Macgrastim Liquid Solution for
activity, potency and toxicity Injection (300 mcg/ 1.2 ml ) VS
with support of iso-electro Neupogen (Innovator):
focusing data, gel  Immunoidentification by
electrophoresis, Western- western blot
Blot and other analytical  Purity by SDS Page
techniques) and stability  Purity by gel filteration
studies of finished biological  Potency protein by
Bradford assay

product  Bilogical activity by cell
proliferation assay
 General safety tests : BET
and sterlity
5 Others Certificate of analysis of bulk
material to be supplied is sunmitted.
(accelerated and real time is
provided)
Clincal data submitted.
Local manfacturing of (biological drugs) M/s Sami Pharmaceuticals (Pvt) Limited, Karachi.
h. PEGINTOR-2a Recombinant Human Peginterfereon Alfa-2a, (180mcg) 0.5ml Pre-

filled syringe of M/s SAMI Pharmaceutical s(Pvt Limited Karachi.

No required as per 246th M/s SAMI Pharmaceutical s(Pvt
meeting Limited Karachi
1 Legalized GMP certificate of Legalized GMP Certificate No. Firm will import the
biological drug as an 20132014-001810-14 dated 30-1- bulk interferon alfa 2a
evidence that the 2015 of M/s LABORATORIO and pegylation will be
manufacturer is an PABLO CASSARA S.R.L done at
authorized manufacturer of Republica Argentina. manufacturing facilty
that particular biological of M/s Sami Pharma
drug in its country of origin. Karachi
2 Structural similarity of Following details are provided for
subject biological drug the bulk concentrate against the
product (concentrate/ ready standard by the M/s
to fill bulk for further LABORATORIO PABLO
processing) with reference CASSARA S.R.L Republica
biological product Argentina.
(innovator)  Appearance
 PH
 Identification:
a. Assay: Protein content,
biological activity
b. Isoelectic focusing
c. Test for impurities fo
molecular masses
differing from that of
interferon alfa 2 (SDS
Page reducing

condition)
d. Peptide mapping
e. impurities fo molecular
masses differing from
that of interferon alfa 2
(SDS Page reducing
and non reducing
condition)
f. related proteins by
HPLC
g. BET
4 Bio-comparability studies Accelerated stability data 6 months
including identity testing to of 3 batches submitted and
parent molecule, purity biocomparibility studies witb
testing, in vitro biological pepgasys are provided with
activity, potency and toxicity fillowing parameters:
with support of iso-electro  Appearance
focusing data, gel  Identification by SDS Page
electrophoresis, Western-  Proetein content by optical
Blot and other analytical density
techniques) and stability  Impurities
 BET
 Sterility
product
5 Others Clinical data provided.
Product specific inspectin for the facility is required. The submitted data needs to be evaluated in
the light of 246th meeting of RB by panel of experts for geniuness and accuracy.
Local Manfacturing of (Biological Drugs) M/S BF Biosciences, Lahore
i. Noxane (Prefilled syringe) (Enoxaprin sodium 20mg/0.2ml, 40mg/0.4ml,

60mg/0.6ml and 80mg/0.8ml) of M/S BF biosciences, Lahre

required as per 246th
meeting
1. Legalized GMP certificate Firm has submitted the Copy of The Director
of biological drug as an GMP Certificate No. SD 20140225 Technical has inform
evidence that the vlidupto 26-5-2019 of M/s that the bulk will be
manufacturer is an Dongying Tiandong Phamraceutical imported from the
authorized manufacturer of Co., Ltd No. 1236, Noner Road, Uroguay. The API in
that particular biological dongying City China, for the said bulk will be

drug in its country of origin. Enoxaparin Sodium used from
2. Legalized COPP No. 156026 dated manufacturer at
09-4-2014 for Noxprin Sodium China.
manufacurerd by Laboratorios
Clausen S.a.- Bulevar Artigas 3896
– Montevideo, Uruguay.
3. Structural similarity of Eludication of structure Following
subject biological drug details are provided by M/s
product (concentrate/ ready Dongying Tiandong Phamraceutical
to fill bulk for further Co., Ltd China.
biological product  Absorption Spectrophotometry
(innovator) , The infrared spectra of sample
is consitent with that of the
CRS
 Absorption Spectrophotometry,
UV spectra is consitent with
that of the CRS
 NMR Spectrophotometry ( 1H
–NMR spectrum and 13C-
NMR cpectrum of thesample is
consistent with those of the
CRS
 Imputities
(Potential Imopurities
Originating from the route of
synthesis), (Potential Impurities
Orininating from the raw
material s and from the
impurities in the raw materials),
(Protein and nucleotide),
Dermatan sulfate) (Heavy
metals) (Bacterial endotoxins),
(Limit of Impurities and
Analytical Methods applied by
the API’s manufacturer),
Protein and nucleotide heavy
metals and bacterial
endotoxins), Dermatan
sulphate), (The Potential
Toxicity of Impurities),
(Residual solvents)
4. Manufacturer to Not provided
manufacture the finished
biological product for trial

studies
5. Bio-comparability studies Not provided
focusing data, gel
product
6. Others
j. Eritrogen (Erythropoetin) 2000IU, 4000IU and 10000IU PreFilled Syringe of M/S BF

Biosciences, Lahre

required as per 246th
meeting
1. Legalized GMP certificate Firm has submitted the Legialized
of biological drug as an GMP certificate No. 20132021-000
evidence that the 033-15 dated 08-6-2015 of M/s
manufacturer is an ZELLTEK S.A, Ruta Nacional No
authorized manufacturer of 168 S/N, Pasaje “EI Pozo’, Parque
that particular biological Tecologico Litoral , of the Province
drug in its country of origin. of Santa Fe, of the Argentine
Republic.
2. Structural similarity of Under Eludication of structure of

subject biological drug API, comparative analysis with
product (concentrate/ ready EPO Standard BPR is provided by
to fill bulk for further M/s ZELLTEK S.A, Argentine
processing) with reference Republic.

biological product
(innovator)
 Glycoform analysis
 Primary Structure
 Secondary Structure
 Tertiary structure
 Disulfide bridges
 N-terminal sequence
 Sialic Acid Content
 Native N-glycans profile
 Neutra N-glycans profile
 O-glyscosilatin site occupation
 Content of dimmers and
related substances of high
molecular weight
 Invivo biological activity.
3. Manufacturer to Not provided
manufacture the finished
biological product for trial
studies
4. Bio-comparability studies Not provided
focusing data, gel
product
5. Others
Decision: Regiatration Board deliberated and deferred these applications that manufacturing
and quality control of biological products require specialized facilities and approval
from the Licensing Division, DRAP. The Baord dicussed that theses manufacturing
units have already been granted registrations of various biological products for local
manufacturing (mostly therapeutic proteins). As theses firms have applied for
registration for local manufacturing of various biological products including rDNA
products, Theraputic protein, Monocronial antibodies, Vaccines (Live, Attentuated,

rDNA vaccines, so the Board decided to have opinion of licensing division DRAP
regarding approved manufacturing facilities (categories of biological products) of
these firms and status of already registerd biological drugs from these firms.
Case No.05: As per decision of 258th meeting of RB. All the cases of import of Heparin are placed
below for a joint collective decision as per recommendation of WHO.
a. Deferred case of M/s Ghazali Brothers Karachi in 258th meeting of Registration Board
Following product of M/s Ghazali brothers Karachi are deferred by the Registration
Board 254th meeting for completion of applications, remaining fee, CoPP status, information regarding
availability in country of origin and deliberations regarding requirement for bio-similarity of products.
Sr. Name of Brand Name & Type of Document Remarks

No Importer & Composition Form details
Manufacturer (CoPP)
Dy No &
Date of Me too
application status/New
molecule
Fee
submitted
Pack size/
Demanded
Price
1. Ghazali Brothers, VAXCELL Form-5A Legalized Product is
Karachi. Heparin CoPPCertific available in
Sodium Injection Dy No. 43 ate No. 0346/ country of origin
KotraPharma(M) 5000 IU/ml dated 03-03- 2015 dated and full fee as
SdnBhd, Jalan 2011 10-03-2015 required is
TTC 12 Each 5ml submitted. Firm
ChengIndustrial contains:- 15000/- dated Me too has submitted the
Estate,Melaka, Heparin 03-03-2011 clinical data/
Malaysia. Sodium…..25000I 3500/- dated biosimilarity data
U 09-10-2012
50000/- dated
Anticoagulant 16-06-2015
Shelf life: three

years Rs.540/ 5ml

Decision: Registration board deliberated that WHO exempts Heparins and Enoxaprin from
the condition of biosimilarity. Keeping in view this position, the Board approved the
above products for registration as per Import Policy for Finished Drugs.
b. Deferred case of M/s Shamco Traders (Pvt) Limited, Lahore in 258th meeting of
Registration Board.
S.#. Company Name Brand Name Date of Document Remarks

and Name of and application/Fe ary details
Manufacturer Composition e status
13. M/s Shamco POLIPARIN Form-5A CoPP No
Traders (Pvt) 25000 IU/ 5ml 2014/ 335
Limited, Lahore IV/ SC Dy No. 1241 dated 22-
Injectable vial dated 12-10-15 07-2014
License Holder:
PolifarmaIlacSanayi Each 5ml vial Rs 100000 Copy of
VeTicaretAS contains: dated 12-10-15 GMP dated
TozkoparanMah. Heparin 15-08-2013
HaldunTaner&SkAl sodium……250 625/ vial valid up to
parsalanMerkezi 00IU 12-2015
Istanbul
Manufacturer:
MefarIlac San AS
RamazanogluMah.
Ensar Cad. No: 20
34906
KurtkoyPendik
Istanbul.
Decision: Registration board deliberated that WHO exempts Heparins and Enoxaprin from
c. Registration of Import Product Namely Medirin Heparin Sodium 5000IU/ml &

25000IU/ml M/s Medi Mark Pharmaceutical Lahore and Hepacin Injection 25000
iu/5ml, Bajwal Sons, Lahore
M/s Medi Mark Lahore had applied for registration of Medirin Injection (Heparin) 25000
IU/5ML and Medirin Injection (Heparin) 5000IU/ml and M/s Bajwa sons, Lahore had applied for
registration of Hepacin Injection 25000 iu/5ml. Both companies have same manufacturer abroad. The
case is being placed 254th meeting before the Registration Board. The decision of 254th Registration
Board meeting as follows:

“Registration Board deferred the case. M/s Medi Mark and Bajwa sons has same source. Firm will be
advised to provide latest Whole Sale Agency Certificate from manufacturer. Complete information for
CoPP is also required”.
Later on the M/s Medi Mark has provided copy of sole agency agreement with its Chinese
manufacturer. The document is not on the company letter head nor has been notarized. The Medi Mark
provided also copy of CoPP. The case was placed on agenda of 256th meeting of Registration Board.
Documentary details as below:
S.#. Company Name and Name of Product Date of Remarks

Name of / Composition application / Fee
Manufacturer status
1. Medi Mark Pharma, MEDIRIN INJECTION Date of Me too

Lahore. 5000IU/ML Application
23-05-2013
Furen Pharmaceutical Composition
Group Co., Ltd, Fee deposited
Address: 1 (Heparin Sodium Rs.100000/-
Xuan Wu Economic Injection 5000 IU/ml )
Developing -area, Balance fee
Luyi Country, Henan Anti Coagulant Nil
China.
Address 2:
No.1 Tongyuan road,
Industrial centralized
area, LuYi County,
Henan Province
China
2. Medi Mark Pharma, MEDIRIN INJECTION Date of Me too

Lahore. 25000 IU/5ML Application
23-05-2013
Furen Pharmaceutical Composition
Group Co., Ltd, (Heparin Sodium Fee deposited
Address: 1 25000IU/5ml) Rs.100000/-
Xuan Wu Economic
Developing -area, Anti Coagulant Balance fee
Luyi Country, Henan Nil
China.

Address 2:
No.1 Tongyuan road,
Industrial centralized
area, LuYi County,
Henan Province
China
Registration Board decided as follows:
“Registration board considered above applications of Medi Mark Pharma, Lahore and
advised to provide legalized CoPPs and notarized sole agency agreement.”
M/s Medi Mark has now provided the legalized CoPP (original) and notarized sole agency
agreement as per directions of the Registration Board.
Decision: Registration Board considered the request of M/s Medi Mark Lahore and referred the
applications for expert opinion of the following:
i. Brig. (R) Muzamil Hussain Najmi, Member Registration Board.

ii. Brig. Abid Azhar, AFIP, Rawalpindi.
iii. Dr. Masud-ur-Rehman, DDG DRAP, Islamabad.
“M/s Medi Mark is advised to provide the notarized sole agency agreement from country of
origin. As two manufacturing sites are mentioned on CoPP submitted by M/s Medi Mark
Lahore, therefore clarification will be obtained from firm about manufacturing site. The
application of M/s Bajwa Sons Lahore will be considered after aforementioned
clarification”.
M/s Medi Mark has submitted Legalized and Notarized Sole Agency Agreement and Notarized
cancellation letter from Furen Pharmaceutical Group Co., Ltd. China as per directions of the Registration
Board in 257th meeting mentioned above.
Decision: Registration Board deliberated that WHO exempts Heparins and Enoxaprin from

d. Grant of Registration Human Imported product Enclex 40 (Enoxaparin Sodium Injection
IP 40MG/0.4ml) M/s AJ Mirza Pharma (Pvt) Ltd, Karachi.
M/s AJ Mirza Pharma (Pvt) Ltd Karachi has applied for grant of registration
HumanImported product Enclex 40 (Enoxaparin Sodium Injection IP 40MG/0.4ml). Product details is as
1. M/s AJ Mirza Enclex 40 Form 5-A Legalized COPP Valid and
Pharma (Pvt) No. legalized
Ltd, Karachi (Enoxaparin 831/MFG/WHO- COPP/ FSC
sodium Injection GMP/DFDA/201 along with
IP 40mg/0.4ml Dy. No. 29 R&I
DRAP dated 10- 2/1742 valid up GMP
Cipla Ltd 289, Each prefilled 10-2014 to 14-6-2014Certificate
Bellasis Road, syringe contains: from India need to be
Mumbai submitted as
Enoxaparin per above
Central, Fee deposited:
Mumbai 400 Sodium Rs. 100000/- Product License decision of
008 India IP…….40mg. No. 704 dated 255 th
meeting.
dated 10-10-2014
Equivalent to 4000 08-4-2005
IU anti-Xa
activity. Condition of
Packs: 0.4ml PFS inspection
Water for Injection abroad as per
Ip…….q.s. DML No. import policy.
831/MFG/CERT/
DFDA/12/5863
Pharmacological dated 06-2-2012
group:
Antithrombotic
agent, low
molecular weight
Heparin.
Route of
Adminstration:
Intara Venous &
Sub cutaneous
under:

2. M/s AJ Mirza Enclex 60 Form 5-A Legalized COPP Valid and
Pharma (Pvt) No. legalized
Ltd, Karachi (Enoxaparin 831/MFG/WHO COPP/ FSC
sodium Injection GMP/DFDA/201 along with
IP 60mg/0.6ml Dy. No. 28 R&I
DRAP dated 10- 2/1734 valid up GMP
Cipla Ltd 289, Each prefilled 10-2014 to 14-6-2014Certificate
Bellasis Road, syringe contains: from India need to be
Mumbai submitted as
Central, Enoxaparin per above
Fee deposited:
Mumbai 400 Sodium Rs. 100000/- Product License decision of
008 India IP…….60mg. No. 704 dated 255 th
meeting.
dated 10-10-
Equivalent to 6000 2014. 08-4-2005
IU anti-Xa
Condition of
activity.
DML No. inspection
Water for Injection Packs: 0.6ml PFS 831/MFG/CERT/ abroad as per
Ip…….q.s. DFDA/12/5863
import policy.
Pharmacological dated 06-2-2012

group:
Antithrombotic
agent, low
molecular weight
Heparin.
Route of
Adminstration:
Intara Venous &
Sub cutaneous.
e. Grant of Registration Human Imported product Heparodic 5000 (Heparin sodium)

M/s AA Pharma, Karachi.
M/s AA Pharma, Karachi has applied for grant of registration Human Imported product
Heparodic 5000 (Heparin sodium) Product details is as under:

S. Name of Importer Brand Name & Dy No & Date of Document Remarks
No & Manufacturer Composition application/ Fee details (CoPP)
status/ Pack size/
demanded Price Me too status
1 M/s AA Pharma, HEPARODIC 5000 Form 5-A Legalized Me too
Karachi (Heparin sodium COPP available
5000U/ml Dy No. 958 R& I from Islamic
Caspian tamin IV, Deep SC DRAP dated 17-3- Republic of
PhamaceuticalCo. Injection 2014 Iran
First Entrance, Rasht IV infusion
Industrial Zone, P.O. Each 1ml ampule Fee deposited: Rs. Product
Box: 43375-1116, (injectable 50000/- dated 07- License No.
Rasht-Iran solution) contains: 11-2012 + Rs. IRC
Heparin sodium 50000/- dated 31- 1228049750
USP……5000IU 12-2014 dated 04-7-
Benzyl alcohol 2011
B.P……9.45 MG Balance fee: Nil
Sodium chloride Legalized Free
B.P…….. 9 mg Sale Certificate
Water for injection available from
USP……..q.s the country of
origin
f. Cases of Imported Human Biological Drugs ENOXAPRIN M/s Allmed

Laboratories, Karachi
S.No. Name of Brand Name & Dy No & Document Decision in

Importer & Composition Date of details 257th RB
Manufacturer application/ (CoPP)/ Meeting
Fee Status/ International
Pack size/ availability/
Price Me too status
1. M/s Allmed ENOXA 2000 IU Dy No. 1140 Market Deferred for
Laboratories, A- anti Xa 20mg R&I dated authorization expert opinion
21/3 KDA Solution Injectable 2 23-5-2014 no. 9233494 of following:
Scheme No. 1 Syringes / 0.2 ml until valid 05- a. Dr. Abid
Ext Karachi 15000 dated 2017 Azhar,
Pakistan One prefilled 02-1-2012 Sole agency A.Q.Khan
Institute of
syringe of 0.2 ml 85000/- dated agreement
Biotechnol
Les contains: 11-10-2012 dated 23-11- ogy,
Laboratories Enoxaparin Sodium 2015 University
of Karachi.

Medis Route De ……20mg As per PRC/ b. Dr.
Nabeul Km Pack of 2’s Clexane Zeeshan
78000 Nabeul Antithrombotic syringes prefilled Danish,
University
Tunise syringes
of the
(MHRA) Punjab.
c. Prof. Dr
Clexane PFS Ghias Butt,
of Sanofi PIMS
Karachi Islamabad.
2. M/s Allmed ENOXA 4000 IU Dy No. nil Market Deferred for

21/3 KDA Solution Injectable 2 26/5/2014 no. 9233494 of following:
Scheme No. 1 Syringes / 0.4 ml until valid 05-a. Dr. Abid
Institute of
Biotechnol
Medis Route De ……40mg As per PRC/ of Karachi.
Nabeul Km Pack of 2’s Clexane b. Dr.
78000 Nabeul Antithrombotic syringes prefilled Zeeshan
Tunise syringes Danish,
University
(MHRA)
of the
Punjab.
Clexane PFS c. Prof. Dr
of Sanofi Ghias Butt,
Karachi PIMS
Islamabad.
Scheme No. 1 Syringes / 0.6 ml until valid 05- a. Dr. Abid
Institute of
Biotechnol
University
(MHRA)
of the
Punjab.

Karachi PIMS
Islamabad.
Scheme No. 1 Syringes / 0.8 ml until valid 05-a. Dr. Abid
Institute of
syringe of 0.8 ml 85000 dated agreement
Biotechnol
University
(MHRA)
of the
Punjab.
Karachi PIMS
Islamabad.
The expert opinion of above products have no been received yet.
g: Cases of Imported Human Biological Drugs Heparin sodium 25000IU M/s Genome
Phamra, Rawalpindi
S.No. Name of Brand Name & Dy No & Date Document

Importer & Composition of application/ details
Manufacturer Fee Status/ (CoPP)/
Pack size/ International
Price availability/
Me too status
1. Genome NEFRIN Form 5-A Legalized valid
Phamra, Injection COPP is required
Rawalpindi Dy No. 119 As the firm has
Each 5 ml R&I DRAP submitted copy of
contains: dated 11-1- COPP issued on
Belmedpreparat Heparin sodium 2016 dated 07-8-2014.

y RUE 25000IU
Republic of Fee deposited Copy of sole agency
Belarus Pharmacological Rs.100000/- agreement is
group: Anti dated 30-12- submitted.
cogualant 2015
Orignal legalized
Shelf life : Price: Not documents are
03years provided. required.
Decision: Registration Board approved NEFRIN Injection as per Import Policy for Finished
Drugs. The firm will provide the original legalized CoPP and sole agency agreement
and Chairman RB will allow further processing of the case as per Import Policy for
Finished Drugs.
Deferred/ Miscellenous Cases
Case No.06: Following product of M/s BroMed animal Health, Lahore are deferred in the 258th meetin
of RB due to non submission of original legalized GMP Certrificate. The firm has now provided the
legalized GMP certificate. The case is placed before the board for consideration please.
Sr. Name of Brand Name & Type of Form Document Remarks Decision
No Importer & Composition details
Manufacturer Dy No & Date of (CoPP)
application
Me too
Fee submitted status/New
molecule
Pack size/
Demanded Price
1. BroMed animal TRI- Dy No. 2841 Product Reg The Firm has Approved As
Health, Lahore APHTHOVAC (R&I) DRAP No 614 submitted GMP Per Valid
dated 21-12-2015 Dated certificate Legalized
Inactivated Foot 19/02/2014 legalized COPP And
Middle East for & mouth Tri- Fee deposited: Legalized through Import Policy
Vaccines (ME vlent Vaccine Rs.100000/- dated Free sale Embassy of For Finished
VAC) Strain A Iran05, 18-12-2015. dated 17-09- Pakistan Drugs
Industrial area 2 O Pan Asia 2, 2015
Piece 22-24, Asia 2, Asia 1 20/50/100/300 ml Condition of
New Salhia, el Shamir vial inspection
Sharkia Head abroad as per
Office : 20 Each ldose (2ml) import policy.
Jospeh teto el contains:
nozha el gededa, Inactivated FMD

Cairo, Egypt. Virus Serotype A
Iran 05……≥ 108
TCID50 per dose.
(4 ug of viral
protein / Dose
which is
equivalent to 6
PD50/ dose).
Inactivated FMD
Virus Serotype O
Panasia 2……≥
108 TCID50 per
dose. (4 ug of
viral protein /
Dose which is
equivalent to 6
PD50/ dose).
Inactivated FMD
Virus Serotype
Asia 1
Shamir…..……≥
108 TCID50 per
dose. (4 ug of
viral protein /
Dose which is
equivalent to 6
PD50/ dose).
Montanide Isa
50…….1ml
Inactivant
BEI……….3mM
Bulk
saline…………..
Q.S. to2ml
Total ……….2
ml
Protection of
cattle dairy sheep
goat from FMD
Shelf life: 24
months
Route : SC

2. BroMed animal ME FLUVAC Dy No. 2842 Product Reg The Firm has Approved As
Health, Lahore H9+ND 0.3% (R&I) DRAP No 653 submitted GMP Per Valid
Inactivated dated 21-12-2015 Legalized certificate Legalized
Bivalent Virus Free sale legalized COPP And
Middle East for Vaccine against Fee deposited ; dated 17-09- through Import Policy
Vaccines (ME Avian influenza Rs.100000/- dated 2015 Embassy of For Finished
VAC) H9N2 and 16-12-2015 vide Pakistan Drugs
Industrial area 2 Newcastle challan no.
Piece 22-24, disease. 0131605 Condition of
New Salhia, el inspection
Composition:
Sharkia Head 300 ml vial abroad as per
Inactivated
Office : 20 import policy.
Avian Influenza
Jospeh teto el
A /Chicken
nozha el gededa,
/Egypt/114940v/
Cairo, Egypt.
NLQP /2011
(H9N2)……≥108
EID50/dose
before
inactivation.
Inactivated
Newcastle
Disease
NDV/Chicken/E
gypt/11478AF/2
011
(ND)……≥108EI
D50/dose before
inactivation.
Mantonied Isa
71VG…021 ml
BNE
……..0.0005 G
Bulk saline ……
Q.S.to 0.3ml
Total ….. 0.3ml
Protection
against AI, and
ND
Shelf life 24
months
Route: IM/SC

3. BroMed animal MEVAC IB+ND Dy.No. 2844 Product Reg The Firm has Approved As
Health, Lahore Inactivated (R&I) DRAP No 630 submitted GMP Per Valid
trivalent Virus dated 21-12-2015 Legalized certificate Legalized
Vaccine of Original free legalized COPP And
Middle East for Infectious Fee deposited; sale certificate through Import Policy
Veterinary Bronchitis Rs.100000/- dated dated 20-06- embassy of For Finished
Vaccines (ME Disease. 16-12-2015 vide 2015 Pakistan. Drugs
VAC) challan
Egypt. Each (0.5ml) ml no.0131609. Condition of
contains: inspection
500 & 300 ml vial abroad as per
Inactivated Virus import policy.
Vaccine of
Infectious
Bronchitis
Disease of IB
Classical
(Eg/11539F)&
IB Variant type 2
(Eg/1212B)……
≥107EID50/dose
at release.
Inactivated
Newcastle
Disease
NDV/Chicken/E
gypt/11478AF/2
011
(ND)……≥108EI
D50/dose at
release
(>128PD50).
Mantonied Isa
70V……0.35 ml
Formaldehyde
solution
…..0.0045ml
Bulk saline ……
Q.S.to 0.5ml
Total …. 0.5ml

Immunization
against IB and
ND
Shelf life: 24
months
Route : IM/ SC
4. BroMed animal ME FLUVAC Dy No. 2845 Legalized The Firm has Approved As
Health, Lahore H9 0.3% (R&I) DRAP Original free submitted GMP Per Valid
(Inactivated virus dated 21-12-2015 sale certificate certificate Legalized
Vaccine against dated 20-06- legalized COPP And
Middle East for Avian influenza Fee deposited: Rs. 2015 through Import Policy
Vaccines (ME H9N2) 100000/- dated 16- Embassy of For Finished
VAC) 12-2015. vide Pakistan Drugs
Industrial area 2 Each (0.3ml) challan no.
Piece 22-24, dose contains: 0131604.
New Salhia, el Condition of
Sharkia Head Inactivated Packs: 300 ml vial inspection
Office : 20 Avian Influenza abroad as per
Jospeh teto el A /Chicken import policy.
nozha el gededa, /Egypt/114940v/
Cairo, Egypt. NLQP
/2011(H9N2)…
…≥108EID50/do
se before
inactivation.
Protection
against influenza
Shelf life: 24
months
Route : IM/ SC
5. BroMed animal ME VAC ND Dy No. 2843 Legalized The Firm has Approved As
Health, Lahore Broiler (R&I) DRAP Original free submitted GMP Per Valid
Inactivated Virus dated 21-12-15 sale certificate certificate Legalized
Vaccine against dated 20-06- legalized COPP And
Middle East for Newcastle Fee deposited: Rs. 2015 through Import Policy
Vaccines (ME disease 100000/- dated 16- Product reg Embassy of For Finished
VAC) 12-2015 vide no 651 dt Pakistan Drugs
Industrial area 2 Each 0.3 ml dose challan no. 8/5/2014
Piece 22-24, contains: 0131607. Condition of
New Salhia, el inspection
Sharkia Head Inactivated 300 ml vial abroad as per

Office : 20 Newcastle import policy.
Jospeh teto el Disease
nozha el gededa, NDV/Chicken/E
Cairo, Egypt. gypt/11478AF/2
011
(ND)……≥108EI
D50/dose before
inactivation.
Protection
against ND
Shelf life: 24
months
Route : IM/ SC
Case No.07: Cases of Imported Products of Veterinary Biological Drugs M/s SNAM
Pharma, Lahore
M/s Snam Pharma, Lahore applied the new registration of following Veterinary Biological
Products. The Registration Board considers the request in 256th Registration Board meeting. The decision
of 256th RB meeting is below:
Decision of 256thRB: Approved as per import Policy for Finished Drugs.
The firm is provided registration certificates of three (03) Eastern Europe Countries as per Import
Policy. Product details as under:
Name of Manufacturer Name of Drug Date of Document Remarks

Sr #. Indenter/ (s)/ Composition applica ary Details
Manufactur & Therapeutic tion /
er Group Fee
status
1. M/s SNAM BIOVETA, Biofel PCH Date of CoPP No. Me too
Pharma a. s. emulsion for applicat 047/2014
61-G Komenskeho injection for cats ion dated 01-4- 1. Marketing
Defense 212, 683 23 25-11- 2014 Country: Romania
Housing Ivanovice na Active Substance 2014
Authority , Hane, Czech Prod Market
Lahore Republic, Virus Fee License No. authorization No.
panleucopeniae deposite 97/004/06- 130217dated 22-
contagiosae felis d C dated 01- 11-2013.
inactivatum, 06-2006

satrain FPV-Bio Rs.1000 2. Marketing
7 00/- Free Sale Country: Republic
vide Certificate of Poland
Calicivirus felis Challan No.
inactivatum, No 048/2014 Authorization No.
strain FCV F 9- 022788 dated 01-4- 2398/14 dated 18-
Bio 8 0 dated 2014 12-2014
27-11-
Herpesvirus felis 2014 GMP 3. Marketing
inactivatum, Certificate Country: Hungary
strain FHV-1-Bio Balance No.
9 fee 178/2012/C Marketing
Nil GMP dated Authorization
03-9-2012 No.3612/1/14
NEBIH ATI
(1dose) dated 1-
12-2014
2. M/s SNAM BIOVETA, Biocan Puppy Date of CoPP No. Me too
Pharma 61- a. s. lyophilisate for applicat 057/2014
G Defense Komenskeho the preparation of ion dated 01-4- 1. Marketing
Housing 212, 683 23 injection 25-11- 2014 Country: Romania
Authority , Ivanovice na suspension with 2014
Lahore Hane, diluent Prod Market
Czech Republic, Fee License No. authorization No.
Composition- 1 deposite 97/011/04- 120087 dated 21-
ml (1 dose): d C dated 04- 3-2012.
a) Component D 02-2004
(freeze-dried) Rs.1000 2. Marketing
Virus febris 00/- Free Sale Country: Slovak
contagiosae canis vide Certificate Republic
min. 10 4.2 Challan No.
TCID50 – MAX. No 058/2014 Market
10 5,0 TCID50 022787 dated 01-4- authorization No.
9 dated 2014 97/115/99-S dated
b) Component P 27-11- 12-12-2012
(fluid) 2014 GMP
Parvovirus Certificate 3. Marketing
enteritidis canis Balance No. Country: Republic
inact. Min. 1024 fee 178/2012/C of Bulgaria
HAU- max. 4096 Nil GMP dated
HAU 03-9-2012 Marketing
Authorization of
Veterinary
product No,

0022-1461 dated
14-7-2015
3. M/s SNAM BIOVETA, Biocan DHPPi+L Date of CoPP No. Me too

Pharma 61- a. s. lyophilisate for applicat 209/2014
G Defense Komenskeho the preparation of ion dated 03-7- 1. Marketing
Housing 212, 683 23 injection 25-11- 2014 Country: Hellenic
Authority , Ivanovice na suspension with 2014 Republic (Greece)
Lahore Hane, diluent Prod
Czech Republic, Fee License No. Marketing
Composition- 1 deposite 97/046/02- authorization No.
ml: d C dated 06- 81940 dated 22-9-
06-2002 2014.
Freeze-dried Rs.1000
Component 00/- Free Sale 2. Marketing
Virus febris vide Certificate Country: Republic
contagiosae canis Challan No. of Poland
min. 10 3.0 No 210/2014
TCID50 – max. 10 022787 dated 03-7- Authorization No.
4.5
TCID50 8 dated 2014 2010/10 dated 21-
Virus 27-11- 10-2010
laryngotracheitidi 2014 GMP
s contagiosae Certificate 3. Marketing
canis min. 10 3.5 Balance No. Country: Hungary
TCID50 – max. 10 fee 178/2012/C
4.5
TCID50 Nil GMP dated Marketing
03-9-2012 Authorization
Parvovirus No, 250/1/09
enteritidis canis MgSzH ATI
min. 10 4.5 (1dose) dated 21-
TCID50 – max. 10 4-2015
5.5
TCID50
Virus
parainfluensis
canis min. 10 3.0
TCID50 – max. 10
4.2
TCID50
b) Liquid
component
Leptospira
icterohaemorrhag

iae inact.
Min.titre 32
defined by
MAT*)
Leptospira
canicola inact.
Min.titre 32
defined by
MAT*)
Leptospira
grippotyphosa
inact. Min.titre
32 defined by
MAT*)
*) geometrical
mean of titres of
specific
antibodies
defined by
microagglutinatio
n test
3. Two Veterinary Biological Products namely Biocan Puppy (lyophilisate for the preparation of
injection) and Biocan DHPPi+L (lyophilisate for the preparation of injection ) of M/s Snam Phamra,
Lahore deferred in 256th Registration Board meeting for expert opinion of confirmation of need vis-à-vis
compatibility with local immunogenic requirement safety profile product.
Pannel of experts are as under:
a. Dr. Qurban Ali Animal Husbandary Commissioner, Ministry of National Food Security,
Islamabad.
b. Prof. Dr. Khushi Muhammad, UVAS, Lahore
c. Prof.Akram Munir, Ripha University, Lahore
1. The opinion of Prof. Dr. Khushi Muhamad against Biocan DHPPi and Biocan Puppy Vaccine
are as under:
Comments: Based on the “quality control data, results of the experimental trails and composition of the
Vaccines”, it can be stated that vaccines against the said canine disease in Pakistan seem to be safe and
effective.
It is therefore recommended that the said vaccines may be registered in Pakistan in the best interest of
canine lovers.

2. The opinion of Prof. Dr. Muhamad Akram Muneer, Riphah International University,
Lahore against Biocan DHPPi and Biocan Puppy lyophilisate Vaccine are as under:
Comments against Biocan Puppy lyophilisate:The technical data provided in the dossier supports the
efficacy of this vaccine product against CD Aand CPV. In view of supporting documents I recommend
that the registration of this vaccine may be considered by the Registration Board.
Comments against Biocan DHPPi+L lyophilisate: The technical data support the efficacy of this
multivalent vaccine against canine distemper (CDV), infectious canine hepatitis (CAV-1), infectious
laryngotracheitis (CAV-2), parvovirus infection (CPV), parainfluenza (CPIV-2) vivid and leptospirosis in
dogs. I recommend consideration of this multivalent preparation by the registration board.
3. The Opinion of Dr. Qurban Ali, DG, NVL, Islamabad against Biocan Puppy
lyophilisate and Biocan DHPPi+L lyophilisate are as under:
Biocan Puppy lyophilized is a two component vaccine for active immunization of dogs against canise
distemper and parvovirus. The subject vaccine is a veterinary requirement especially for the pet dogs in
the country. The dossier has merits of clear description of technical contents. The product is registered in
the country of origin, multiple European and developed and developing countries. The product is
recommended.
Biocan DHPPi+L is a multicomponent veterinary caccine containing veterinary vaccine containing

freeze dried and liquid components having biological entities. The vaccine is required for pet dogs for
immunization against multiple diseases for the age of eight weks and above. The technical application has
scientific contents with clear description of technical details. The product is registered in country of
origin, multiple developed and developing countries. The product is recommended.
Decision: Registration Board approved avove Product as per Import Policy for Finished
Drugs. The firm shall provide legalized and Notarized COPP from three regulatory
bodies of Eastern European countries, where the drug is registered for purpose of
the waiver of inspection aborad as required as per Import Policy for Finished
Drugs.
Case No.08: Deferred cases Registration of Products of M/s Mustafa Brothers, Faisalabad
Following veterinary vaccine products of M/s Mustafa Brothers Faisalabad are deferred for
submission of valid legalized documents i.e. CoPP or Free sale certificate with GMP, issued by the
regulatory agency of country of origin with certified English translation in 257th meeting of Registration
Board. The firm has submitted the documents. The evaluation is detailed below for consideration of
Registration Baord please.
S. Name of Brand Name & Dy No & Date Document Remarks

No Importer & Composition of application/ details (CoPP)
Manufacturer Fee status/
Pack size/ Me too status
demanded

Price
1. Mustafa Virus Vaccine Dy. No.600 State Registration Firm has
Brothers against infectious (R&I) dated No. submitted valid
Faisalabad. bursal disease from 12-6-2012 1047796296437 lealized
BG strain “ARRIAH dated 11-8-2011 documents i.e.
Manufacturer GUMBORO VAC” Free sale
Contains:- Fee Rs.15000/- certificate with
Federal Infectivity of the virus dated 12-6- DML No.00-11- GMP issued by
Governmental vaccine shall be at 2012 + 85000/- 1-001221 dated the regulatory
Budgetary least 104.5EID50/cm3 dated 01-2- 11-8-2011 agency of
Institution One dose of the 2016 country of origin
“Federal Centre vaccine shall contain GMP Registration with English
for Animal 103 EId50 Balance Fee N 4-4060 translation
Health” (FGBI (Vaccine). Nil enclosed
“ARRIAH”, Pharmacological Condition of
Vladimir, group: inspection
Russia. Vaccine. abroad as per
import policy.
2. Mustafa Vaccine against Dy No. 599 Product .Firm has

Brothers chicken infectious (R&I) dated Registration No. submitted valid
Faisalabad. bronchitis from strain 12-6-2012 1023/301283720 lealized
“H-120” strain live Fee Rs. Dated 26-7-2011 documents i.e.
Manufacturer dry Contains:- 15000/- dated Free sale
12-6-2012 + State Registration certificate with
Federal One immunizing 85000/- dated No. GMP issued by
Governmental vaccine dose contains 01-2-2016 1047796296437 the regulatory
Budgetary not less than 104 EID50 Dated 26-12- agency of
Institution of the chicken Balance fee 2011 country of origin
“Federal Centre infectious bronchitis Nil with English
for Animal virus (‘H-120” strain, Legalized Free translation
Health” (FGBI serotype sale Certificate
“ARRIAH”, Massachusetts). Registration N 1- Condition of
Vladimir, 2347 enclosed inspection
Russia. Pharmacological abroad as per
group: GMP Registration import policy.
Vaccine N 4-4060
encosed.
3. Mustafa Associated Vaccine Date of DML No. 00-11- Firm has

Brothers Against Newcastle application 1-001220 Dated submitted valid
Faisalabad. Disease 12-Jun-2012 11-8-2011 lealized
Infectious Chicken enclosed. documents i.e.
Manufacturer Bronchitis and egg Fee Rs.15000/- Free sale

drop syndrome-76 dated 12-6- Legalized Free certificate with
Federal inactivated emulsion 2012+ 85000/- Sale Certificate GMP issued by
Governmental dated 01-2- No. N 1-2346 the regulatory
Budgetary Pharmacological 2016 encosed. agency of
Institution group: Balance Fee country of origin
“Federal Centre Vaccine for prevention NIL GMP Certificate with English
for Animal of Newcastle Disease No. N 4-4060 translation
Health” (FGBI Infectious Chicken Packing of 400 copy enclosed.
“ARRIAH”, Bronchitis and egg doses in a Condition of
Vladimir, drop syndrome-76 in bottle. inspection
Russia. breeding and abroad as per
marketable pultry import policy.
farms and farms of
other categories that
have poultry.
4. Mustafa Virus vaccine against Dy No. 596 Prod Reg No. Firm has
Brothers Bursal disease from (R&I) dated 1023301283720 submitted valid
Faisalabad. Winterfield Disease 12-6-2012 Dated 26-7-2011 lealized
2512 strain documents i.e.
Manufacturer Fee Rs. GMP No. 0011-1- Free sale
One Immunizing dose 15000/- dated 001221 certificate with
Federal of vaccine shall 12-6-2012 26-12-2011 GMP issued by
Governmental contain: the regulatory
Budgetary 4,0 lg EID50 of 85000/- dated Free Sale agency of
Institution attenuated virus of 01-2-2016 Certificate No. 4- country of origin
“Federal Centre infectious bursal 4078 with English
for Animal disease of Winter field Balance Fee translation
Health” (FGBI strain 2512 Nil
“ARRIAH”, Condition of
Vladimir, Composition: inspection
Russia. abroad as per
Active substances: import policy.
Virus of infectious
bursal disease (IBDV)
(strain Winterfield-
2512), titer of
infectivity at lease 6.0
lg EID50/cm3.
Pharmacological
group:
The vaccine is used
for prophylactic
immunization of

chickens and chicks
against infectious
bursal disease.
5. Mustafa Virus Vaccine Dy. No.600 State Registration Firm has

Brothers against infectious (R&I) dated No. submitted valid
Faisalabad. bursal disease from 12-6-2012 1047796296437 lealized
BG strain “ARRIAH dated 11-8-2011 documents i.e.
Manufacturer GUMBORO VAC” Free sale
Contains:- Fee Rs.15000/- certificate with
Federal Infectivity of the virus dated 12-6- DML No.00-11- GMP issued by
Governmental vaccine shall be at 2012 + 85000/- 1-001221 dated the regulatory
Budgetary least 104.5EID50/cm3 dated 01-2- 11-8-2011 agency of
Institution One dose of the 2016 country of origin
“Federal Centre vaccine shall contain GMP Registration with English
for Animal 103 EId50 Balance Fee N 4-4060 translation
Health” (FGBI (Vaccine). Nil enclosed
“ARRIAH”, Pharmacological Condition of
Vladimir, group: inspection
Russia. Vaccine. abroad as per
import policy.
Decision: Registration Board approved above five products as per Import Policy for Finished
Drugs and valid legalized COPP
Case No.09: Change in Name of company and address already registered and unregistered
products of M/s Sanofi-Aventis Pakistan Ltd.
M/s Sanofi-Aventis Paksitan has applied for the change in name of company and address
for the following products:
i. Shanvac B 1ml (Reg.No. 0456371) already registerd product.
ii. Shanvac B 0.5ml (Approved in 240th RB meeting and under process in Pricing)
iii. Shanvac B 5ml MD (Approved in 240th RB meeting and under process in
Pricing)
iv. Shan TT 0.5ml single vial (Approved in 240th meeting of RB and 12th DPC.
v. Shan TT 0.5ml SD (35x0.5ml) (Approved in 240th meeting of RB and 12th
DPC.
vi. Shan TT 5ml MD (30x5ml) (Approved in 240th meeting of RB and 12th
DPC.
M/s Sanofi-Aventis Pakistan Ltd has requested that the state of Andhra Pradesh by virtue of the
Andhra Pradesh Reorganization Act 2014 has been split in to two states Andhra Pradesh and Telangtana
fro mid of 2014.

As a result of Reorganization Act the manufacturing unit located in erstwhile Andhra Pradesh are
now came into existence in the reorganized Telangana and as per fresh certificate of incorporation
consequent upon conversion from public company to private company issued by ministry of corporate
affairs, w.e.f. 19-11-2014. The change of name and address details are as under:
Old Name of Company and Address New Name of Company and address
Shantha biotechnics Limited Shantha biotechnics Private Limited
Survey No. 274, Athvelli village, Medchal Survey No. 274, Athvelli village, Medchal
Mandal – 501401, Ranga Reddy district, Mandal – 501401, Ranga Reddy district,
Andhra Pradesh, India Telangana, India
Firm has submitted fee against each product Rs. 5000/- , Legalized COPP and other legal documents.
Decision: Keeping in view the approval of change of name and address by the regulatory body
of exporting country (valid legalized CoPP), the Registration Board approved the
change of name and address of manufacturer from Shantha biotechnics Limited
Survey No. 274, Athvelli village, Medchal Mandal – 501401, Ranga Reddy district,
Andhra Pradesh, India to Shantha biotechnics Private Limited Survey No. 274,
Athvelli village, Medchal Mandal – 501401, Ranga Reddy district, Telangana, India.
Case No.10: Deferred Case of 256th RB, Request for additional pack size by M/s. Snam Pharma,
Lahore.
M/s Snam Pharma Lahore may be advised to submit the separate application / dossier
alongwith COPP and case may be taken up in the next Registration Board meeting. However the opinion
of Secretary, Registration Board may also be taken on the instant case for further clarification.
Product Biocan R injection is registered Veterinary Product in multiple dose vial (Reg.No.
057167). The firm requested additional volume/ pack in single dose form as per COPP issued by
regulatory body of Czech Republic. The Registration Board acceded to the request of firm in 256 th RB
meeting. Now the clarification is needed wether the firm shall follows the policy of submitting separate
application dossier along with full fee as per policy adopted on human drugs.
The firm has submitted the balance fee of 95000/- other formalities are complete. Case is submitted
before board please.

Decision: Registration Board deferred the request of additional pack volume 1ml x 20 doses of
Biocan R bearing Registration No. 057167 and advised to submit application on
Form-5A with requisite details.
Case No.11: Transition of Formulation from Lyophilized To Liquid Form of WinRho SDF
Injection (025216) M/s Eastern Trade and Distribution Co. Pvt Limited Karachi
M/s Eastern Trade and Distribution Co. Pvt Limited Karachi have informed that their
principal M/s Cangene Corporation, Canada is transitioning the formulation of their registered product
WinRho SDF Injection from lyophilized to Liquid formulation. The existing formulation was supplied as
freeze dried powder I vial along with single ampoule of sterile water for injection, while the new
formulation is liquid injection will contain a convenient formulation ready to use 3ml single dose vial of
1500IU (300mcg) of Anti Rho (D) in glass vial
The liquid formulation is approved by Health Canada, detailed below:
Existing WinRho SDF Lyophilized New approved SDF Liquid formulation

formulation composition
Each vial contains: Each vial contains:

Human Anti-D Immunoglobulin (in Human Anti-D Immunoglobulin (in
house)………300 mcg house)………300 mcg
Glycine Ph. Eur/ USP……22.5 mg Maltose USP………………..0.135g

Saodium chloride Ph. Eur/ USP…..7 mg Ploysorbate 80 Ph. Eur/ USP…..0.39mg
Ploysorbate 80 Ph. Eur/ USP…..0.3mg Water for Injection Ph. Eur/ USP……QS *
Water for Injection Ph. Eur/ USP……QS *
* Removed by lyophilization.
The firm has submitted the following documents:
a. 5000 fee in respect of above application

b. Copy of registration letter along with renewal evidence.
c. USFDA Approval and CoPP issued by Health Canada for liquid formulation.
d. Specifications of new excipients.
e. Data of long term (36 months) and accelerated (6months) stability studies.
If approved by the board, we may direct the firm to apply afresh, as it is new dosage design. The case
is submitted for consideration of Board please.
Decision: Registration board did not acceed to the request of the firm for change of
formulation from lyophilized to liquid form of Winrho SDF injection (025216) as

present formulation is also approved by regulatory authority of Canada. However
firm was advised to apply fresh application with prescribed fee for new formulation/
dosage design.
Case No:12 Reditux TM Injection applied by M/s Macter International Limited
S. Name of Brand Name /Drug Dy No & Document Decision of RB

No Importer composition Date of details
& application/ (CoPP)
Manufactu Fee status/
rer Pack size/ Me too status
demanded Remarks
Price
1. Macter Reditux TM Injection Date of The reference Deferred for expert
Internationa 100mg Each 10ml application product is opinion of following
l (Pvt) vial 2.02.2011 Ristova by a. Brig (Retd),
Limited, contains :- Roche. Muzamil Hasain
Karachi. Rituximab (r-DNA Fee deposided The case was Najmi, foundation
origin)…............. 15000 (02-2- recommended Medical College,
Dr. Reddy’s 100mg 2011)+ in 48th ECBD Rawalpindi
Laboratorie (Antineoplastic 85000 (09-10- + b. Brig. Amir Ikram,
s Ltd., Monoclonal 2011) Biosimilarity AFIP, Rawalpindi.
Ranga Antibody). +PICS c. Dr. Masud-ur-
Reddy (For Human Use) Total. 100000 Copies of Rehman DDG,
District, COPP DRAP, Islamabad.
Hyderabad, Original Notarized Balance fee provided,
India. and Legalized GMP Nil valid up to 18-
certificate no. 12-2015.
259//M3B/2014 Structural
issued by Drug similarity of Bioequivalenc
Control subject e and efficacy
Administration, biological Clinical trials
Andhra Pradesh. Date product is data is
Of Issue 13/02/2014 available in submitted
and valid up to provided Safety
18/12/2015. COPP DMF by Studies
no. 2821/M3B/2014 manufacturer. Four years
for finished drug of Protein post marketing
strength 100 mg sequence is surveillance
issued by Drug compared data of 818
Control with WHO patients.
Administration, Govt. sequence.
of Andhra Pradesh. Animal

Original notarized toxicity
and Legalized. Valid studies are
up to 18/12/2015. available in
provided DMF
Indications: by
Non Hodgkin manufacturer
Lymphoma
Antineoplastic
Monoclonal
Antibody
2. Macter Reditux TM Injection Date of The reference Deferred for expert

Internationa 500mg Each 50ml application product is opinion of following
l (Pvt) vial 02.02.2011 Ristova by a. Brig (Retd),
Limited, contains :- Roche. Muzamil Hasain
Karachi. Rituximab (r-DNA Fee deposited The case was Najmi, foundation
origin)…...........… 15000+85000 recommended Medical College,
Dr. Reddy’s 500mg in 48th ECBD Rawalpindi
Laboratorie (Antineoplastic + b. Brig. Amir Ikram,
s Ltd., Monoclonal Balance fee Biosimilarity AFIP, Rawalpindi.
Ranga Antibody). Nil +PICS c. Dr. Masud-ur-
Reddy (For Human Use) Copies of Rehman DDG,
District, COPP DRAP, Islamabad.
Hyderabad, COPP no. provided,
India 2381/M3B/2014 valid up to 18-
issued by Drug 12-2015.
Control
Administration, Govt. Animal Bioequivalenc
of Andhra Pradesh. toxicity e and efficacy
Date Of Issue studies Clinical trials
22/03/2014. Valid up are available data is
to 18/12/2015. in provided submitted
Original notarized DMF by Safety
and Legalized manufacturer Studies:
Four years
post marketing
surveillance
Indications: data of 818
Non Hodgkin patients.
Lymphoma
Antineoplastic
Monoclonal
Antibody

1. EXPERT OPINIONS
BY BRIG. (Retd) PROF MUZAMIL HASAN NAJMI, ON PRODUCTS
(BIOLOGICAL) OF M/S MACTER INTERNATIONAL, KARACHI.
Rituximab is a chimeric monoclonal antibody produced by recombinant DNA technique.

It reacts with the CD20 protein present on the surface of B lymphocytes which are thus
destroyed. Reduction in the number of B lymphocytes results in decreased antibody production
by these cells.
The drug is approved for treatment of certain leukemias and lymphomas including non-
Hodgkin’s lymphoma. It is also used in some of the autoimmune diseases. It is a disease
modifying drug for rheumatoid arthritis, particularly refractory to other treatments.
The drug can cause several adverse effects which include severe reaction after administration as
infusion, cardiotoxicity, lung toxicity, tumor lysis syndrome and reactivation of viral infections
including hepatitis B. However, keeping in view the nature of diseases in which it is used, the
benefit/risk ratio is favorable.
M/S Macter International, Karachi has applied for registration of the brand of Rituximab
which is of Indian origin. The manufacturer, Dr. Reddy’s Lab has provided details of
manufacturing method and biosimilarity studies of their product, Reditux TM injection 100 and
500 mg. The Company has obtained cGMP compliance certificates from USFDA and MHRA of
UK. Having reviewed the data provided, I am of the opinion that both strengths of Reditux TM
injection may be approved so that a cost-effective alternative brand of this drug may become
available for the patients.
2. EXPERT OPINION BY DR. MASUD UR REHMAN, DDG, DRAP ON

BIOLOGICAL PRODUCT OF M/S MACTER INTERNATIONAL, KARACHI
Introduction:
Rituximab a long chain monoclonal antibody is produced by recombinant DNA
technique. Having site of action on CD20 protein present on the surface of B lymphocytes. It
binds there and destroys B Lymphocytes cancerous cell. Reduction in the number of B
lymphocytes results in decreased antibody production by these cells. The drug is approved for
treatment of leukemias, lymphomas including non-Hodgkin’s lymphoma. It is also used in some
of the autoimmune diseases. It is a disease modifying drug for rheumatoid arthritis, particularly
refractory to other treatments.
Evaluation of Dossier:
Product dossier carries scientific data of structural characterization & comparability with
innovator product (Mabthera / Rituxan) in peptide mapping, intact protein mass, UV circular dichorism,
Disulphide bonding pattern by LC-MS. There is comparability / similarity of structure in high order
structure by fluorescence spectroscopy, thermal stability by scanning calorimetric method, glycosialation
analysis by Reagent Array Analysis (RAAM), Charge isomers by IEF, SDS PAGE, SEC HPLC. Potency

is determined by CDC & ADCC. Specific binding of FCγR1, FCγRIIa, FCγRIIB, FCγRIIIa and FCγRn
regions by ELISA, SPR & FACS has also been done.
Pharmacokinetic studies:
Pharmacokinetic and extensive animal toxicology studies data is provided. Clinical efficacy trial
on Non Hodgkin Lymphoma (NHL) of stage II, III and IV patients has shown overall response of 93.8%.
Toxicity data is also provided which is in acceptable range. Four years post marketing safety data of 808
patients is also submitted.
Manufacturers Profile:
Manufacturer of Rituximab is Dr. Reddy’s Laboratories, India. Its a GMP certified manufacturer
by many international regulatory agencies such as Brazil, Peru, QP EU, GCC and Iran. The Company has
also obtained cGMP compliance certificates from USFDA and MHRA of UK.
Recommendations:
M/S Macter International, Karachi has applied for registration of the generic brand of Rituximab.
Reditux generic biosimiler injection may be approved so that a cost-effective alternative brand of this
drug may become available for the patients. Based on aforementioned evaluated specifications by M/S
Macter International, Karachi, the product registration is recommended.
3. Reply of Brig. Amir Ikram, AFIP, Rawalpindi
Thanks for referring the case of Reditux TM Injection 100mg and 500mg strength. Comments are as
below:
1. Product Safety: The provided literature shows that the preparation s are safe. Trials have
been conducted in the country f origin with satisfactory outcome. The manufacturer is following GMPs.
2. Efficacy; The clinical trials conducted in the contry of origin indicate that the
preparations are efficacious, however further evaliuation if requisite may be done.
3. The provided material indicates that the preparations are comparable to

published literature for innovator rituximab. The preparations are required and if probably not incorrect
not much of preparations are easily available within the country. Its transportation under requisite
parameters especially temperature has to be guaranteed by the company at all levels.
The three experts have recommended the products for registration. The case is submitted is before the
board for consideration as per import policy.
Decision: Registration Board considered the expert opinions and approved the registration of
Reditux Injection 500mg manufactured by Dr. Reddy’s Laboratories Ltd., Ranga
Reddy District, Hyderabad, India as per Import Policy for Finished Drugs and valid
legalized CoPP

Case No.13: Hepatitis B Vaccine applied by M/s Macter International Limited.
Following products of M/s Macter International Limited Karachi for local manufacturing were
deferred in the 257th meeting of Registration Board for confirmation of manufacturing facility.
S.#. Name of Brand Name Date of Documentary Remarks

Importer/Man /Composition application/Fee details
ufactruer status/price
1. Macter Biovac HB Out Dy No. 184 Me too a. Firm has

International dated 10.3.2014 submitted the
Ltd. 216, SITE, (Recombinant CoPP FSC
Karachi, Hepatitis B and GMP of
Pakistan (Local Vaccine) Legalized bulk material
Manufacturer) 20000/- dated 21- CoPP No. 2- issued from
20 µg/ml 8-2013 13-A1-1023 regulatory
Republic of body of
Korea Korea.
Bulk material b. Under
source: Price. As per PRC
finished
LG Life Product product
Sciences Korea. License No. specifications
213 dated 29- firm has
12-1994 provided, tests
of Physical
appearance,
aluminum
Legalized Free content,
sale certificate Potency by
No. 2013-A1- Elisa,
1022 dated 08- identification
5-2013 and purity by
SDS-Page,
endotoxin
Legalized GMP bioburden and
Dated 15-3- sterility tests.
2013 enclosed.
2. Macter Biovac HB Dy No.40 DDC Me too a. Firm has

International (BD) Dated 17-3- submitted the
Ltd. 216, SITE, (Recombinant 2014 CoPP FSC
Karachi, Hepatitis B and GMP of
Pakistan (Local Vaccine) Legalized bulk material
Manufacturer) CoPP No. issued from
10 µg/0.5ml Fee Rs. 20000/- 2015-A1-0917 regulatory
Dated 16-7- body of
Dated 21-8-2013 2015 Korea.
Bulk material b. Under
source: finished
LG Life Product product

Sciences Korea. Price: As per PRC License No. specifications
213 dated 29- firm has
12-1994 provided, tests
of Physical
appearance,
aluminum
Legalized GMP content,
No. 2015-F1- Potency by
0102 dated 09- Elisa,
4-2015 identification
and purity by
SDS-Page,
endotoxin
bioburden and
sterility tests.
The firm has submitted that:
Macter’s Biotech manufacturing license covers the formulation, filling and packing of
recombinant DNA technology products. Hepatitis B vaccine is also recombinant DNA technology protein
which is relevant to the license. Recombinant human hepatitis B antigen (rHBsAg) is a polypeptide
protein of 226 amino acid with molecular weight of 24 KDa produced by incorporating genes that code
for important antigens (HBV envelope proteins) into common baker’s yeast (Saccharomyces cerevisiae).
This polypeptide is similar in nature to any other biopharmaceutical products like Interferon alpha which
is 19Kda polypeptide.
This vaccine is entirely different to other categories of vaccines which contain live attenuated or
killed pathogenic organisms (fully or partially). Ready to fill bulk vaccine will be imported from LG
South Korea which is WHO qualified manufacturer for this vaccine (WHO letter for qualification is
submitted. Weblink of WHO site of prequalified manufacturers of rHBsAG is given. Formulated bulk
will be imported and Firm will do filling in vials with online sterile filtration. Details of availability of QC
equipments is attached. Firm has submitted quality & stability data of three batches manufactured locally.
ADC signed invoice of import of ready to fill bulk is provided. Firm’s Biotech manufacturing license
covers the formulation, filling and packing of recombinant DNA technology products. Hepatitis B
vaccine is also recombinant DNA technology protein which is relevant to the license.
Sr. Documents/ data as per Documents / data submitted by Remarks

no. requirement of DRB 246 Macter
1. Legalized GMP certificate Legalized GMP certificate by KFDA Notarized and legalized (by
of biological drug as issued on March 15, 2013. Pakistan embassy Soule, South
evidence that manufacturer Korea) GMP certificate Issued by
is an authorized Korea Food & Drug

manufacturer of that Administration
particular biological drug on March 15, 2013 is submitted.
in its country of origin
WHO pre-qualification letter
Issued by Coordinator quality,
safety and standard is submitted.
WHO prequalification certificate This product & manufacturer are
and Web link of WHO website included in the list of prequalified
link vaccines & manufacturer at WHO
https://extranet.who.int/gavi/PQ_W web link
eb/  https://extranet.who.int/gavi/PQ_
for WHO prequalified vaccine Web/.
manufacturers included in GAVI
program is provided. Notarized and legalized (by
Pakistan embassy Soule, South
Legalized COPP certificate no. 2013- Korea) COPP certificate no. 2013-
A1-1023 issued on May 08, 2013 is A1-1023 issued on May 08, 2013
provided. is provided.
2. Structural similarity of Product characterization is performed Studies are performed by LG life
subject biological drug for comparability with WHO Sciences South Korea are
product (ready to fill bulk) reference standard of NIBSC Hep B available in provided CTD
with reference biological antigen & innovators product Engerix dossier.
product (innovator). B of GSK by SDS PAGE (mol. Wt.),
UV spectrophotometry
(identification), Circular Dichorism
(secondary structure), electron
microscopy (particle morphology),
gradient centrifugation (density),
gradient Centrifugation
(homogeneity), Tryptic digestion &
SDS Page, N Terminal sequence
(identity), C terminal sequencing
(identity), Amino acid composition,
thin layer chromatography
(phospholipid composition),
Antigenicity by ELISA (efficacy),
Size Exclusion Charmatography and
SDS page for purity,
3. Bio comparability studies Comparative analysis of locally Comparative studies of local
including identity testing to produced drug product with batches with innovators product
parent molecule, purity Reference medicinal product (Engerix Engerix B of GSK are provided.
testing, in vitro biological B).
activity / potency testing
and toxicity with support Identity: SDS PAGE
of IEF data, gel Purity: SDS PAGE
electrophoresis, western Potency: ELISA
blot and other analytical General safety tests
methods and stability Bacterial Endotoxin test, Sterility test
studies of finished drug. and abnormal toxicity test.
Real time stability studies for one

year and accelerated stability studies
for 6 months.
4. Others Animal toxicity studies and clinical Pharmacokinetics and
trial studies are submitted toxicological studies are provided.
Section 5.2 requires that dedicated nd self contained facilities for production of particular drug
shall be provided in addition to general facilities sch as highly sensitizing materials ( pencillins or biologicals
preperation, live microorganisams or cytotoxix substances or radio pharamaceuticals or veterinaray
immunological preparation or sterile products or for that matter such hihky active pharmaceutical products,
antibiotics, hormones, as may be identified by the CLB at any stage in order to minimize the risk of serious
medical hazards due to cross contamination, veterinary products contaioning ingrdients similar to those used for
human health and of the sane quality which can be manufactured in the same premises used for manfacture of
pharamacetical products.
It is also described under the above sub rule in exceptional cases of emergency, the prociple of campaign
working in the same facilities may be allowed provided that the specific precautions are taken nd necessary
validations are made.
It is submitted that a discussion was carried out with Licensing Division to discuss the manufacturing
facility for vaccines and other biological products should be separate or can be manufacutered in the same
biotech facility. The Licensing Divisin has desired to make a comprehensive and well thoughtfull delimitation
of manufacturing process being careied out, so the Biological Division and Licensing Division may come up
with comprehensive proposal in the light of existing legislation and international practices being adopted. It is
proposed that the board may allow adaptation of WHO guideline in this regard. (Annex-I)
The case is submitted before the Board for a discussion/delibration/direction on the subject issue by the
Registration Board.
Decision: Regiatration Board deliberated and deferred these applications that manufacturing and
quality control of biological products require specialized facilities and approval from the
Licensing Division, DRAP. The Baord dicussed that theses manufacturing units have
already been granted registrations of various biological products for local manufacturing
(mostly therapeutic proteins). As theses firms have applied for registration for local
manufacturing of various biological products including rDNA products, Theraputic
protein, Monocronial antibodies, Vaccines (Live, Attentuated, rDNA vaccines, so the
Board decided to have opinion of licensing division DRAP regarding approved
manufacturing facilities (categories of biological products) of these firms and status of
already registerd biological drugs from these firms.

Case No.14: Cases of Import Veterinary Product Medivac ND G7B Emulsion and Medivac
Coryza T Suspension M/s Hilton Pharma, Karachi.
S.No Name of Brand Name & Dy No & Date Document Remarks Decision
. Importer & Composition of application details (CoPP)
Manufactur
er Fee submitted Me too status
Pack size
1. Hilton Medivac ND G7B Dy No. 196 Legalized Firm has Approved as
Pharma (Pvt) Emulsion R&I dated 12- Certificate of submitted per Import
Ltd. 3-2014 Free Sale No. Legalized Free Policy for
13, Sector 15, Each dose (0.5ml) 10004/PL500/F/0 Sale Certificate, Finished Drugs
Korangi of vaccine contains 100000/- dated 2/2016 valid until GMP and valid
Industrial inactivated 18-9-2013 January, 2021 Certificate, legalized CoPP.
Area, Newcastle disease Letter of
Karachi, virus MD15 strain Product authorization
Pakistan at least 50 PD 50 Pack Size Registration and Product
Kementan RI No. Stability Data.
Manufacturer Inactivated vaccine 500 ml D-13034471
: for poultry VTC
Name:
PT.MEDION
Legalized GMP
JI.Raya Certificate No.
Batujajar 29 086/MFJ/HK.340
cimareme, /F.5/08/11 Dated
Kabupaten 23-8-2011 until
Bandung- valid 23-8-2016
Indonesia
Authorization
Adress: Ji. Letter No.
Babakan RD/IJ/III/2016/C
ciparay No. 141 dated30-3-
282 Bandung 2016 from
40223 - Medion
Indoneshia Bandung-
Indonesia.
2. Hilton Medivac Coryza T Dy No. 543 Legalized Firm has Approved as
Pharma (Pvt) Suspension R&I dated 04- Certificate of submitted per Import
Ltd. 6-2014 Free Sale No. Legalized Free Policy for
13, Sector 15, Strrength / 10004/PL500/F/0 Sale Certificate, Finished Drugs
Korangi Formulation 100000/- dated 2/2016 GMP and valid
Industrial 04-6-2014 Certificate, legalized CoPP.

Area, Each 0.5ml dose Product Letter of
Karachi, contains: Registration authorization
Pakistan -Haemophillus Pack Size Kementan RI No. and Product
paragallinarum W D-14022729 Stability Data.
Manufacturer strain before 500 ml VTC.1
: inactivation
Name: ≥⁯2x108.0 CFU/ml Legalized GMP
PT.MEDION -Haemophillus Certificate No.
paragallinarum 086/MFJ/HK.340
JI.Raya Spross strain before /F.5/08/11 Dated
Batujajar 29 inactivation 23-8-2011 until
cimareme, ≥⁯2x108.0 CFU/ml valid 23-8-2016
Kabupaten -Haemophillus
Bandung- paragallinarum Authorization
Indonesia Modesto strain Letter No.
before inactivation RD/IJ/III/2016/C
Address: Ji. ≥⁯2x108.0 CFU/ml 141 dated30-3-
Babakan 2016 from
ciparay No. Inactivated Medion
282 Bandung Suspension Bandung-
40223 - Vaccine Indonesia.
Indoneshia against
infectious
coryza
Case No.15: Deferred Cases of 257th Meetong of Registration Board of M/s Amson
Vaccines Pharma (Pvt) Ltd Rawalpindi (WHO Prequalified)
S.No Name of Brand Name / Date of Dicision of 257RB Documents Decision

Importer/Man Composition application/fe Meeting submitted by M/s
ufacturer e status/ Amson Vaccine
Price/pacsk Phamra, Islamabad
1. M/s Amson ComBE Five Dy No. 1216 Deferred for Legalized COPP No. Registration Board
Vaccines & (Suspension for R&I DRAP submission of COPP/RLA/DI/MDL/ approved the
Pharma (Pvt) Injection). dated 25-2- following documents HYD/2016 valid upto product as per
Ltd. Rawalpindi 2016 : 03-9-2017
import policy,
Pakistan
a. Sole agency Legalized GMP Import policy order
Diphtheria, agreement. Certificate No. (Ministry of
Tetanus, Fee Rs. b. Valid legalized Dis.No. Commerce) and as
Manufacturer Pertussis 100000/- CoPP. 10694/E(V)/TS/2015 per valid legalized
(Whole cell), dated 25-2- dated 04/9/2015 valid CoPP.
Hepatitis B 2016 for two years from the
(rDNA) and

M/s. Biiological Haemophilus date of issue WHO
E Limited Type b prequalification
Conjugate Pack size:
status shall be
Vaccine
(Adsorbed) 1ml – Two Legalized Sole verified at the time
18 / 1 7 3, dose Agency Agreement of issuance of
Azamabad, Each dose of dated 6thApril, 2016 registration letter.
Hyderabad, 0.5 ml contains: submitted.
India-500 020.
Diphtheria Shelf life: 24
Toxoid : 25 Lf months, when
(≥30IU) stored at 2-
8oC.
Tetanus toxooid
: 5.5 Lf
(≥60IU).
B. Pertussis :
161 IOU Lf (≥
4 IU)
r-HBs Ag :
12.5 µg.
Purified
capsular
polysaccharide
of Hib
covalently : 11
µg.
Linked to 20 to
36.7 µg of
tetanus toxoid.
A1+++ (as
AIPO4) : ≤1.25
mg
Preservative:
Thiomersal BP
: 0.01% w/v
Pharmacologica
l group:
Vaccine
Vaccines & (Suspension for R&I DRAP submission of DI/BPN/Sec(Mfg)/CO approved the
Pharma (Pvt) Injection). dated 03-2- following PP /18.03.16-02 valid product as per
Ltd. Rawalpindi 2016. documents: up to 25-7-2016
Diphtheria, import policy,

Pakistan Tetanus, a. Sole agency Submitted Import policy order
Pertussis agreement. (Ministry of
(Whole cell), Fee Rs. b. Valid legalized Commerce) and as
Hepatitis B 100000/- CoPP.
Manufacturer dated 03-2- Legalized GMP per valid legalized
(rDNA) and
Haemophilus 2016 Certificate No. Dis CoPP.
Type b No. 1610/M3B/2014
dated 26-7-2014 valid WHO
M/s. Biiological Conjugate
Vaccine for two years from the prequalification
E Limited Shelf life: 24 date of issue.
(Adsorbed) status shall be
months when Submitted
stored at 2- verified at the time
Each dose of of issuance of
18 / 1 7 3, 0.5 ml contains: 8oC.
registration letter.
Azamabad, Legalized Sole
Hyderabad, Diphtheria
Toxoid : 25 Lf Agency Agreement
India-500 020. Pack Size: 2.5 dated 7th April, 2016
(≥30IU) ml Five dose) submitted.
Tetanus toxooid
: 5.5 Lf
(≥60IU).
B. Pertussis :
161 IOU Lf (≥
4 IU)
r-HBs Ag :
12.5 µg.
Purified
capsular
polysaccharide
of Hib
covalently : 11
µg.
Linked to 20 to
36.7 µg of
tetanus toxoid.
A1+++ (as
AIPO4) : ≤1.25
mg
Preservative:
Thiomersal BP
: 0.01% w/v
Pharmacologica
l group:
Vaccine

Vaccines & (Suspension for R&I DRAP submission of COPP/RLA/DI/MDL/ approved the
Pharma (Pvt) Injection). dated 10-3- following HYD/2016 valid upto product as per
Ltd. Rawalpindi 2016 documents: 03-9-2017 submitted
Diphtheria, import policy,
Pakistan
Tetanus, a. Sole agency Import policy order
Pertussis agreement. (Ministry of
(Whole cell), Fee Rs. b. Valid legalized Legalized Sole Commerce) and as
Manufacturer Hepatitis B 100000/- CoPP. Agency Agreement
per valid legalized
(rDNA) and dated 10-3- dated 6th April , 2016
2016 submitted CoPP.
Haemophilus
M/s. Biiological Type b WHO
E Limited Conjugate
prequalification
Vaccine Pack size: Legalized GMP
(Adsorbed) status shall be
Certificate No. Dis verified at the time
5ml – Ten No.
Each dose of
18 / 1 7 3,
0.5 ml contains:
dose 10694/E(V)/TS/2015 of issuance of
Azamabad, dated 04-9-2015 valid registration letter.
Hyderabad, for two years from the
India-500 020. Diphtheria
Toxoid : 25 Lf Shelf life: 24 date of issue.
(≥30IU) months, when submitted
stored at 2-
Tetanus toxooid 8oC.
: 5.5 Lf
(≥60IU).
B. Pertussis :
161 IOU Lf (≥
4 IU)
r-HBs Ag :
12.5 µg.
Purified
capsular
polysaccharide
of Hib
covalently : 11
µg.
Linked to 20 to
36.7 µg of
tetanus toxoid.
A1+++ (as
AIPO4) : ≤1.25
mg
Preservative:
Thiomersal BP
: 0.01% w/v

Pharmacologica
l group:
Vaccine
4. Amson BEtt Dy No. 707 Deferred for Legalized COPP no. Registration Board
Vaccines & (R&I) DRAP submission of COPP approved the
Pharma (Pvt) (Adsorbed Dated 03-2- following /RLA/DI/MDL/HYD/ product as per
Ltd. Rawalpindi Tetanus 2016 documents: 2016 valid upto 20-
Vaccine import policy,
Pakistan 10-2016 from Govt of
[Tetanus a. Sole agency Telangana submitted. Import policy order
Toxoid agreement. (Ministry of
Vaccine] Fee Rs. b. Legalized valid Commerce) and as
Manufacturer 100000/- CoPP or Free per valid legalized
Each 0.5 mL of Sale Certficate Legalized GMP
vaccine Dated 03-2- and GMP Certificate NO. L.Dis CoPP.
contains: 2016 certificate. No.
M/s Biological 8010/AB/(M3)/TS/20 WHO
E Limited Tetanus 14 dated 21-10-2014 prequalification
Toxoid……..≥4 valid for two years the status shall be
0 IU Ten dose vial
of 5ml date of issuance verified at the time
18/1&3, Adsorbed on of issuance of
Azamabad, Aluminium registration letter.
Hyderabad – Phosphate Legalized Sole
INDIA, 500 020 (AIPO4)……. Agency Agreement
≥1.5 mg dated 07-4-2016
submitted
Preservative:
Thiomersal
BP…….0.01%
w/v
Pharmacolgical
group:
Vaccine
Indications:
For active
immunization
against tetanus
in adults,
children and
infants.
5. Amson BEtt Dy No. Deferred for Legalized COPP No. Registration Board
Vaccines & 1215(R&I) submission of COPP/RLA/DI/MDL/ approved the
Pharma (Pvt) (Adsorbed DRAP Dated following HYD/2016 valid upto product as per
Ltd. Rawalpindi Tetanus 25-2-2016 documents: 20-1—2016 submitted
Vaccine import policy,
Pakistan
[Tetanus a. Sole agency Import policy order

Toxoid Fee Rs. agreement. Legalized Sole (Ministry of
Vaccine] 100000/- b. Legalized valid Agency Agreement Commerce) and as
Manufacturer CoPP or Free dated 7th April, 2016 per valid legalized
Each 0.5 mL of Dated 27-01- Sale Certficate a submitted.
vaccine 2016 CoPP.
and GMP
contains: certificate.
M/s Biological WHO
E Limited Tetanus Legalized GMP prequalification
Toxoid……..≥4 Single dose Certificate No. Di. status shall be
0 IU vial of 0.5ml No, verified at the time
18/1&3, 8010/AB/(M3)/TS/20 of issuance of
Adsorbed on 14 dated 21-10-2014
Azamabad, Aluminium registration letter.
Hyderabad – valid for two years
Phosphate from the date of issue.
INDIA, 500 020 (AIPO4)……. Submitted
≥1.5 mg
Preservative:
Thiomersal
BP…….0.01%
w/v
Pharmacolgical
group:
Vaccine
Indications:
For active
immunization
against tetanus
in adults,
children and
infants.
Case No. 16. Deferred case of 256 Meeting of Registration Board for expert opinion
M/s Marush (Pvt) Limited, Lahore
M/s Marush (Pvt) Limited, Lahore has applied for the registration of following biological products
which were considered in the 256th meeting of Registration board. The board deferred the request of
the firm for expert opinion.

Name of Manufacturer Name of product & composition
Vaxxinova GmbH Anton- Cevac new Flu H9 K

Flettner-Str. 6 27472 Each dose contains:-
Cuxhaven, Germany Atleast 109.0 EID50 of inactivated Newcastle disease Virus (strain
Distributed by: CEVA SANTE LaSota) and atleast 108.0 EID50 Avian Influenza Virus (strain
ANIMALE 10 avenue de la H9N2), suspended in the amnio-allantoic fluid from embryonated
Ballastiere Libourne, 33500 SPF hen’s eggs.
France
Laboratories Hipra S.A.Avda. Hipraviar SHS
La Selva Amer (Girona) Spain. Each dose contains:
Live Turkey Rhinotracheitis Virus, strain 1062---------≥102.4
TCID50
Excipiants q.s……….0.03 ml
-do-. Hipraviar B1/H120

1 dose contains:
Live Newcastle disease (ND) Virus, strain B1………….105.5
EID50
Live infectious bronchitis (IB) Virus, strain
H120…………..………….103 EID50
The Reply of experts is as under:
Reply of Dr. Iftikhar Hussain
Based on the data provided in the respective dossiers, the products seem to contain the
required antigenic masses of the respective viral strain present in the product for effective amount of
antibody productions, the above mentioned products may be considered for registration.
Reply of Dr. Muhamad Khalil
In the light of current local epidemiology Newcastle (ND), infectious bronchitis (IB) are
the mostprevalent diseases in local commercial layer, broiler & breeder farms, whereaa swollen head
syndrome (SHS) is common disease problem of commercial layer & breeding flocks. All types of
chickens in Paksitan are being vaccinated regularly against these diseases through similar combinations as
of the subject vaccines. It is also cited in the literature that similar vaccines are also carried out in Pakistan
and world wide where commercial poultry is grown.
Keeping in view the local epidemiology, data presented and review of the literature. I feel
the subject veterinary biologics are suitable for prevention of above cited diseases.
Therefore, I recommend to register these vaccines in Pakistan.
Reply of Dr. Masood Rabbani, UVAS, Lahore is still awaited
The case is submitted before the board for consideration please.
Decision: Registration Board considered the expert opinions and approved the registration of
Cevac new Flu H9 K, Hipraviar SHS, Hipraviar B1/H120 vaccine

Case No.17. Deferred Cases of 257th Me too of Registration Board of Sanofi-Aventis Pakistan
Limited, Karachi
Name of Brand Name / Date of Dicision of Documents Decision

Importer/ Composition application/fee 257RB Meeting submitted by
Manufactu status/ Price/pacsk Sanofi-Aventis
rer Pakistan Limited,
Karachi
Sanofi- THYROGEN Application submit Deferred for The firm has The Product is
Aventis (R&I) Section dated submission of submitted USFDA approved,
Pakistan (Thyrotropin following: Legalized so Registration
Limited, alfa, 09-6-2014 Board approved
Karachi thyrotropin a. Legalized COPP No. 04- the registration of
alfa for CoPP/ GMP 0013-2014-02-PK product as per
Product injection) & Free Sale Dated 29/4/2014
Fee Rs. 100000/- Certifcate. import policy and
License valid legalized
b. Orignal sole
holder (also Dated 09-6-2014 agency CoPP.
packager, Each vial agreement. Product License
labeler & c. Stability data
contain 1.1mg Holder No. 20-898
batch of finished
thyrotropin To be submitted at dated 30-11-1998
release): product.
alfa (Each 1 time of price fixation/
Genzyme ml contains box of 2vials.
Corporatio 0.9 mg/ml of GMP Certificate
n, 11Forbes thyrotropin No. UK GMP
Road, alfa when 24655 Insp GMP
Northborou reconstituted
22907/37128-0005
gh, MA with 1.2 ml [H] dated 31-12-
USA water for 2012.
injection)
Manufactur
er:
The stability data
Hospira Pharmacologic
has also been
Inc. 1776 al group:
submitted.
North Pituitary and
Centennial Hypothalamic
Drive Hormones and
McPherson, Analogues,
KS
67460USA Shelf life:
three years.

Case No.18: Deferred Cases of M/s Acumen Pharmaceuticals Rawalpindi in the 258 th meeting of
Registration Board
Following product of M/s Acumen Pharmaceuticals Rawalpindi, are deferred in the 258 th
meeting of registration board for submission of valid legalized CoPP from country of origin and if not
available in the country of origin, then valid reason thereof.
Sr. No Name of Brand Name Type of Form Document Remarks Decision of

Importer & & details 258th RB
Manufacturer Composition Dy No & Date (CoPP)
of application/
Fee status/ International
Avalaibality
Pack size/
demanded Me too
Price status
1. Acumen DICLAIR Dy No. 258 Legalized Legalized Deferred for
Pharmaceutical HP-HCG dated 13-1-15 /original CoPP of submission of
s, For Injection COPP NO Belgium valid legalized
Rawalpindi Rs. 100000/- 109-07-14 submitted CoPP from
Each vial dated 13-1- dated 19-7- Product is country of origin
BBT Biotech contains: 2015 2014 of not and if not
GmbH Arnold Human Federal available available in the
Sommerfeldrin Chorionic Price 1500/vial Agency 97 in the country of
g Gonadotopin Medicine and country of origin, then valid
28 ………….50 health origin .( reason thereof.
52499Baeswile 00IU Belgium. declared
r for
Germany. Treatment of Me too export).
an ovulatory Molecule
infertility is me too.
Shelf life 36
months
2. Acumen DICLAIR Form 5A COPP No. Legalized Deferred for
Pharmaceutical HP-FSH 209-07-14 CoPP of submission of
s, Each vial Dy No. 260 dated 19-7- Belgium valid legalized
Rawalpindi contains: dated 13-1- 2014 (Copy submitted CoPP from
2015 submitted) Product is country of origin
BBT Biotech Folical Federal not and if not
GmbHArnoldS stimulating Rs. 100000/- Agency 97 available available in the
ommerfeldring Hormone dated 131-15 Medicine and in the country of

28 75IU health country of origin, then valid
52499Baeswile Beljium. origin. reason thereof.
r Induction of Price 1500/vial (declared
Germany. ovulation for
export).
Shelf life: 36 Molecule
months is me too.
3. Acumen DICLAIR Dy No. 259 Legalized Legalized Deferred for
Pharmaceutical HP-HMG dated 13-1-15 /original CoPP of submission of
s, Each vial COPP NO Belgium valid legalized
Rawalpindi contains: Rs. 100000/- 1023-12-14 submitted CoPP from
Folical dated 131-15 dated 23-12- Product is country of origin
BBT Biotech stimulating 2014 of not and if not
GmbHArnoldS Hormone Federal available available in the
ommerfeldring 75IU Price 1500/vial Agency 97 in the country of
28 Medicine and country of origin, then valid
52499Baeswile Luteinizing health origin .( reason thereof.
r hormone Beljium declared
Germany. 75IU for
export).
Shelf life: 36 Molecule
months is me too.
The firm has submitted a letter from BBT Bio Tech GmbH Germany that the above products are
not marketed in European markets yet, as there was no economical interest for that.
All registration s made in our home market, are only of interest in case the product can have a
status of reimbursement. The social security of western European countries were not reimbursing the
human gonadotrophin until recently.
As European authorities do change the rules of re-imbursment, giving our products

(gonadotrophin) an economical reason to be registered, we can inform that we are now starting MRP
registration process. This process will take some time as we will then cover all countries of the ECC.
Therefore we can conclude that BBT-Biotech GmbH is starting now registration procedures for,
consecutively, HMG, HCG and FSH, throughpartners and /or in direct form.
Our manufacturing sites/facilities are fully GMP/WHO approved. All necessary authorizations are
available including the CPP format declaring that sales on export are allowed by our Ministry of Health.
Decision: Registraion Board considered the request of the firm. The reason submitted by the firm
for non registration of products in country of origin was from the manufacturer and not
from the regulatory body. The board is of the view that the reason is not sufficient for
granting registration. The board deferred the products till registration in the country of
origin as per policy

Case No. 19 Deferred case of 258th Meeting of RB M/s LDS (Pvt) Ltd Rawalpindi.
Sr. Name of Brand Name & Type of Form Document Decision of Decision
th
No Importer & Composition details (CoPP)/ 258 Meeting
Manufacturer of RB /
International Remarks
Dy No & Date of Avalaibality/ Me
application/ too status
Fee status/
Pack size/
demanded Price
1. M/s LDS (Pvt) PEDA TYPH Dy No. 502 dated Legalized COPP Defered in Deferred for
th
Ltd Vaccine single 22-1-15 NO. 258 RB submission of valid
Rawalpindi. dose vial Drug/837/403 meeting for legalized CoPP/
valid upto 23-1- confirmation FSC and GMP,
Rs. 50000/- dated 2016 from India of formulation evidence of
M/s BioMed Each dose vial 22-1-2015 in reference approval of product
Pvt Ltd C-96 0.5ml contains: drug agencies in reference
site No.1 Single dose vial and agencies and WHO
Bulandshar 5ug of Vi Rs.495/- submission of prequalification
Road Industrial polysaccharide valid legalized status as per import
Areal of Salmonella CoPP. policy order for
Ghaziabad UP typhi conjugated importibilty from
to 5ug Tetanus The firm has India
India. submitted only
toxoid protein in
isotonic saline legalized free
0.5ml. sale certificate.
Immunization Confirmation
against of fee is
salmonella in required
infants of age ≥
6 months
children and Approval of
adults product in
reference
Shelf Life agencies is
36months required.

2. M/s LDS (Pvt) Bio Typh Form 5-(A) Legalized COPP The firm has Deferred for
Ltd No. submitted only submission of
Rawalpindi. Drug/837/403 legalized free following
(Tphoid vaccine) Date of application dated 23-1-2016 sale certificate.
from India. a. Valid legalized
CoPP/ FSC and
M/s BioMed Single dose vial 53 DDC (BD) dated GMP,
Pvt Ltd C-96 , Multi (5) dose 22-1-16 b. WHO
site No.1 vial Product License prequalification
Bulandshar No. 05/LVP/Sera Confirmation status as per
Each dose of of fee is import policy
Road Industrial (0.5 ml) Fee deposited; & Vaccines/2004
required orders for
Areal contains: Vi Rs.50000/- dated dated 20-5-2004 importibilty from
Ghaziabad UP polysaccharide 20-1-2016 India.
India. of Salmonella c. Clarification
MHRA from the firm for
typhi (strain Free sale selection of pack
ty2)-25mcg certificate No. approved
Demande price; size.
Isotonic saline single dose vial Drug/837/37
I.P. q.s.- 0.5ml Rs.160/- and Multi dated 16-1-2015
dose vial Rs. 525/- from the country
Proposed dosage of origin
a. For adults :
0.5 ml Pack size:
Letter of
b. Children by 1. Single dose vial authorization No.
age group : 0.5 BM/PK/LDS/BT/
ml (after 2 years 2. Multi (5) dose
071015 dated 07-
of age) vial
10-2015 from the
c. Infants & country of origin.
special groups :
Not
recommended
Pharmacological
group: Vaccine
Route of
administration :
Intramuscular or
subcutaneous
Clinical use:
Recommended
for prevention of
typhoid fever.

Case No.20 Case of M/s. Graton Pharma, Karachi for registration of Interferon Alfa 2B 3000IU
/Vial (Lipheron from Beijing Shanglu, China) along with diluent.
The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration of
Interferon Alfa 2b 300MIU injections 22.6. 2011. The request consider in 256th Registratin Board meeting
and deferred for expert opinion. The product details is as under;
S.No Company Name of Name of Date of Documentary

Name Manufacturer Products application / Details
Fee status
1. M/s Graton Beijing SL Recombinant Date of CoPP No.

Pharma office # Pharmaceutical Human application 20150204 dated
102, First Co., Ltd. Interferon alfa 2b 10-2-2015
Floor, The for injection
Plaza, Block-9 No.9.
Clifton, Zhongyuan Strength: 3M
Road, Badachu IU/vial Prod License No.
Karachi. Fee Deposited S20100501 dated
High Tech.
Park, Rs.15000/- 18-9-2010.
Shijingshan dated 22-6-2011
District, + 35000/- dated
Beijing, 09-10-2012+ GMP Certificate
P.R.China 50000/- dated No. CN
11-6-2015 20130327
DATED 31-10-
2013
Free Sale
Certificate No.
2015-14 dated
02-1-2015
validity 02 years.
The firm has now submitted the legalized CoPP No . 20150204 dated 10-2-2015 Prod License No.
H20100501 dated 18-09-2010. Submitted for consideration of Registration Board please.
Decision: Registration Board considered the case and referred the above application of the firm for
expert opinion by following experts:
a. Brig (R), Muzamil Hussain Najmi, Member Registration Board.

b. Brig. Amir Ikram, AFIP Rawalpindi.
c. Dr. Masud-ur-Rehman, DDG, DRAP, Islamabad.
Inspection of the manufacturer abroad can be conducted after the expert opinion.

Expert Opinions are as under:
1. EXPERT OPINION OF BRIG. AAMER IKRAM, AFIP,

RAWALPINDI
Thanks for referring the case; comments are as below:
1. Product Safety:
The Preparation seems to be safe. The original manufactures is following GMPs. Toxicological
reports after testing are also attached and are satisfactory. Post market surveillance is also satisfactory.
2. Efficiency:
The provided literature shows that the preparation is efficacious. The trials have been conducted
in the country of origin. Further trials may be done here if required.
3. Themolecular descriptin seems satisfactory. The preparation is required; however its

transportation under requisite parameters especially temperature has to be ensured by the company at all
levels.
2. EXPERT OPINION OF DR. MASUD UR REHMAN, ADDITIONAL DIRECTOR

(BIOLOGICAL DIVISION) DRAP, FOR (LIPHERON) INTERFERON ALPHA
2B 3000 IU OF M/S GRATON PHARMA, KARACHI, IS AS UNDER:
Introduction:
Human interferon-α 2a or 2b are well-known characterized proteins consisting of 165
amino acids. The non-glycosylated protein has a molecular weight of approx. 19,240 KD. It
contains two disulfide bonds, one between the cysteine residues 1 and 98, and the other between
the cysteine residues 29 and 138. The sequence contains potential O-glycosylation sites. Physico-
chemical and biological methods are available for characterisation of the proteins. Recombinant
IFN-α 2a or 2b is approved in a wide variety of conditions such as viral hepatitis B & C,
leukaemia, lymphoma, renal cell carcinoma and multiple myeloma. It is used alone or in
combination in oncology indications. Interferon-alpha may have several pharmacodynamic
effects. The sub-types Interferons alpha 2a and 2b have different clinical use. In general,
interferon-α 2a or 2b use in oncology indications has reduced considerably had been superseded
by other more effective specific treatments. Treatment with recombinant interferon alpha 2a or
2b is associated with a variety of adverse reactions such as flu-like illness, fatigue, and myalgia.
A variety of immunemediated disorders such as thyroid disease, rheumatoid arthritis, systemic
lupus erythematosus, neuropathies and vasculitis have been observed with r-IFN-α.

Pharmacology of Product:
The product Lipheron is produced by Beijing SL Pharmaceutical Company, it has provided general
pharmacological action studies at (P 50) which are line with documented action of product as mentioned
in intrduction. Interferon induce pleiotropic biologic responses which include antiviral, antiproliferative,
and immunomodulatory effects, regulation of cell surface major histocompatibility antigen (HLA class I
and class II) expression and regulation of cytokine expression. Company has provided antiviral activity
studies done in vivo using chi cell model (P 65).
Pharmacokinetics:
The pharmacokinetic properties of Interferons were evaluated in normal, healthy volunteer
subjects after subcutaneous injection of 1 mcg, 3 mcg, or 9 mcg Interferons. Plasma levels of
interferon after subcutaneous injection administration of any dose were too low to be detected by
either enzyme-linked immunosorbent assay (ELISA) and by inhibition of viral cytopathic effect.
Antiviral Activity in Cell Culture:

The antiviral activity of interferon against HCV or HCV-derived replicons in cell culture has
been studied and were upto mark.
In vitro studies:
In order to compare any alterations in reactivity between the similar and the reference
medicinal products, data from a number of comparative bioassays (e.g. receptor-binding studies,
antiviral effects in cell culture, antiproliferative effects on human tumour cell lines), is provided.
Standardised assays are used to measure activity and potency (p 65).
In vivo studies:
To support the comparability exercise for the sought clinical indications, the
pharmacodynamic activity of the similar biological medicinal and the reference medicinal
products quantitatively compared is provided:
An appropriate pharmacodynamic animal model (e.g. evaluating effects on

pharmacodynamic markers of serum 2´,5´-oligoadenylate synthetase activity) are provided.
Pharmacodynamic measurements are performed as part of repeat-dose toxicity studies. &
provided (P 64). Toxicological studies data from toxicity study in a relevant species is provided.
The study is performed in accordance with the requirements of the “Guideline on similar
biological medicinal products containing biotechnology-derived proteins as active substance. A
guidance for assessing systemic exposure in toxicological studies is provided. (P 62- 67)

• Data on local tolerance is also provided in accordance with the guidance on non
clinical local tolerance testing of medicinal products.
• Safety pharmacology, reproduction toxicology, mutagenicity and carcinogenicity
studies are also provided.
Clinical Studies:
Company provided phase II clinical trial to evaluate safety & tolerability in HCV patients
(page 41) conclusion was that it is well tolerated. Company has provided phase II clinical trial to
determine maximum tolerated dose in renal cell cancer patients (P 23). Company has provided
phase III clinical trial in patients suffering from HBV, results and are in line with innovators (P
1-22). Company provided Phase IV clinical trial in patients suffering from HCV results are in
line with innovators (P 33). Company provided post marketing surveillance data which is in line
with published results of innovator on (P 44).
Pharmacovigilance plan:
Company has provided a risk management programme / pharmacovigilance plan in
accordance with current WHO legislation and pharmacovigilance guidelines. Attention has been
paid to immunogenicity and potentially rare and/or delayed serious adverse events, especially in
patients undergoing chronic administration. Company also provided product recall system 74-
78).
1) Safety of Lipheron;
Company has provided following studies. Single dose toxicity data on mice. Repeat dose
toxicity data on rats. Repeat dose toxicity data on Dogs. Genotoxicity & mutagenicity
studies. Phase II human studies. Phase II human studies to determine maximum tolerated
dose.
2) Efficacy of Lipheron;
Company has provided following studies. Post marketing surveillance studies. Phase III
trail. Multi-center study to determine efficacy. Phase IV study to demonstrate efficacy &
safety, Phase II human studies. Phase II human studies to determine maximum tolerated
dose
Structural Comparative Studies with Innovator:
The company has done purity studies by Chromatogram of purity by HPLC. UV

Spectrum of Stack Spectra Image report. QC reort showing molecular weight, bands and
standered lines. Isoelectric focusing spectrum, Peptide mapping and host cell DNA test has been
done.

Administrative documents’ showing legalized GMP, evidence that manufacturer is
authorized manufacturer in country of origin. The provided credentials show that Graton Pharma
is their authorized agent. Provision of bio-comparability studies including identity testing to
parent molecule, purity testing, in vitro biological activity, clinical studies, stability studies of
product, and certificate of analysis of finished product.
After detailed evaluation it is found that product is safe & have efficacy in different
indications of (Recombinant Human Interferon Alpha 2 b) and shall be cost effective to poor
patients. Moreover result of Structure Comparison Studies is similar with Innovator Intron A.
The authenticity of data / documents / adapted protocols cannot be verified here. At the
time of inspection of the firm, the authenticity of all provided documents, their systems /
protocols of manufacturing / quality control / abnormal toxicity etc need to be evaluated on spot
through vigilant inspection. The CoPP and GMP certificates legalized and notarized however
confirm the availability of product in country of origin. Lipheron (interferon alpha 2 b 3000 IU)
is hereby recommended for consideration of registration based on provided documents.
3. THIR EXPERT OPINION OF BRIG (R), MUZAMIL HUSSAIN NAJMI,

MEMBER REGISTRATION BOARD, DRAP, IS STILL AWAITED.
Decision: Registration Board considered the expert opinions. The third expert Brig. Muzamil
Hssain Najmi, whose reply was still awaited, also agreed to recommendations of
other two experts. Based of the recommendations of all three experts, Registration
Board approved the registration of Lipheron Injection (Recombinant Human
Interferon alfa 2b for injection 3M IU vial) manufactured by M/s . Beijing SL
Pharmaceutical Co., Ltd. No.9. Zhongyuan Road, Badachu High Tech. Park,
Shijingshan District, Beijing, P.R.China as per import policy and valid legalized
CoPP. The firm shall also submit separate Form 5A, fee and CoPP for registration
of diluent.
Case No.21 DEFERRED CASE IN 257TH MEETING OF RB (DENGVAXIA, POWDER AND

SOLVENT FOR SUSPENSION FOR INJECTION (DENGUE TETRAVALENT
VACCINE (LIVE, ATTENUATED). M/S SANOFI-AVENTIS PAKISTAN
LIMITED, KARACHI
S. Name of Brand Dateof Documentary Decision of 257th

No Importer/Manfa Name/Composi application/Fee details RB Meeting
. cturer tion status/
Packs/Price
1. Sanofi-Aventis DENGVAXIA, Dy No. 940 (R&I) COPP NO. Deferred for

Pakistan Limited, powder and dated 16-2-2016 2016010813450 evaluation of
Karachi solvent for 4 Dated 25-1- clinical data by
suspension for 2016 FDA following experts:
Republic of

Injection Fee Rs. 200000/- Philippines. a. Maj. Gen.
dated 15-2-2016 Muhammad
Manufacturer (Dengue for powder and Aslam, Member
tetravalent Registration
solvent Product License
vaccine (live, Board.
attenuated). No. BR-1128 b. Dr. Huma,
Sanofi Pasteur Dated 22-12- PMRC,
Parc Industrial MRP 9500/- per 2015 Islamabad.
Incarville, 27100 c. Represenrative
dose
Val de Reuil One dose (0.5 of malaria
France. ml) contains: control, WHO
GMP Certificate Pakistan,
CYD dengue Pack size: No. Islamabad.
virus HPF/FR/222/20
Final release site: serotype1,2,3,4 15 Dated 05-10-
………….each 1. Powder (1 dose) 2015
4.5-6.0 log10
in vial + 0.5 ml of France
Sanofi Pasteur CCID50/dose solvent in pre-
NVL 31-33 quai filled syringe with
Armand Barbes 2 separate needles
69250 Neuville- Pharmacologica (pack size of 1).
sur-Saone l group:
France.
ATC code:
J07BX 2. Powder (1 dose)
in vial + 0.5 ml of
J solvent in pre-
(ANTINEFECT filled syringe with
IVES FOR 2 separate needles
SYSTEMIC (pack size of 10).
USE) 07
(VACCINES) B
(VIRAL
VACCINES) X
(OTHER viral
vaccines)
2. Sanofi-Aventis DENGVAXIAT Dy No. 941 (R&I) COPP NO. Deferred for

Pakistan Limited, M MD, powder dated 16-2-2016 2016010813450 evaluation of
Karachi and solvent for 1 Dated 25-1- clinical data by
suspension for 2016 FDA following experts:
Injection Fee Rs. 200000/- Republic of
Philippines. a. Maj. Gen.
Manufacturer: (Dengue dated 15-2-2016 Muhammad
tetravalent for powder and Aslam, Member
solvent Registration
vaccine (live,
Board.

Sanofi Pasteur attenuated). Product License b. Dr. Huma,
NVL 31-33 quai No. BR-1129 PMRC,
Armand Barbes MRP 9500/- per Dated 22-12- Islamabad.
dose Pack size: c. Represenrative
69250 Neuville- One dose (0.5 2015
of malaria
sur-Saone ml) contains: control, WHO
France. Pakistan,
CYD dengue 1. Powder (5 GMP Certificate Islamabad.
virus doses) in vial + No.
serotype1,2,3,4 2.5 ml of solvent HPF/FR/222/20
………….each in vial (pack size 15 Dated 05-10-
4.5-6.0 log10 of 5). 2015
CCID50/dose
NVL SITE,
France.
Pharmacologica
l group:
ATC code:
J07BX
J
(ANTINEFECT
IVES FOR
SYSTEMIC
USE) 07
(VACCINES) B
(VIRAL
VACCINES) X
(OTHER viral
vaccines)
1. EXPERT OPINION OF DR. HUMA QURESHI, EXECUTIVE DIRECTOR,

PMRC, ISLAMABAD IS AS UNDER:
The 1st dengue vaccine is produced by Sanofi and is licensed and being used in Mexico. It is also
available on WHO website. Its phase 3 tgrials have been published in New England Journal of Medicine.
The vaccine is given in 3 doses at 0,6,12 month’s interval and has shown excellent protection in
various dengue serotypes. For serotype 4, protection was seen in 77% for serotype 3 it was 71%, for type
2 it was 43% and for type 1 it was 54%.
Pakistan has been facing outbreaks of dengue infection since many years and each outbreak
causes large morbidity, additional hospitalization cost and some ortality. Panic during outbreak causes
huge out of pocket spending for undergoing various tests and treatments.

Evidence shows tht exposure to dengue and its recovery does not protect the individual from
second exposure, in fact 2nd exposure makes the patient more vulnerable to complications like bleeding,
shock and death.
A national study done all over Pakistan by Pakistan Medical Research Council in 2013, showed
that 32% population who had no history of suffering from dengue fever had actually suffered from
dengue fever, as seen by the presence of IgG antibodies in their blood. It can be stipulated from this study
that a large population of Pakistan is vulnerable to dengue complications in every new outbreak.
It is therefore strongly recommended that dengue vaccine may be registered in Pakistanfor

future ude and protection of the population.
2. EXPERT OPINION OF SYED KHALID SAEED BUKHARI, COUNTRY

ADVISOR MEDICINE & HEALTH PRODUCTS, REPRESENTATIVE OF WHO
PAKISTAN IS AS UNDER:
As you are aware that Dengue is a major health burden all across the world, which can
affect anyone regardless of age, sex, underlying health, or socioeconomic status.
Pakistan is now considered Endemic for Dengue, and in order to limit Dengue, and
integrated approach is optimal for prevention and contro of Dengue. Vector-control efforts prove
to be unsustainable in preventing dengue disease; this gives rise to a need for the inclusion of a
safe and effective dengue vaccine in Countries endemic with Dengue disease.
During the Q & A session with WHO in 2014, WHO commente4d that a safe, effective
and affordable dengue vaccine would repreent amajor advance for the control of the disease and
could be an important tool for reaching the WHO goal of reducing Dengue morbidity by at least
25% and mortality by at least 50% by 2020.
In March 2016, WHO Strategic Advisory Group of Experts on Immunization (SAGE)

issued recommendations on Dengue vaccine that supports the use of the vaccine in endemic
countries. The SAGE recommendations provide important validation of the efficacy, sfety,
quality and potential public health value of the existing Dengue vaccine.
Based on the SAGE recommendations and the WHO initiative to control Dengue, it is
theefore essential that Dengue vaccine is introduced in Pakista in ordr tolimit the burden of
Dengue outbrteaks in the country.
The pricing of the Dengue vaccine should be as per the DRAP regulatory rules.

3. THIRD EXPERT OPINION OF MAJ. GEN. MUHAMMAD ASLAM, MEMBER
REGISTRATION BOARD, DRAP, IS STILL AWAITED.
Recommendations of WHO Strategic Advisory Group of experts (SAGE):
The World Health Organization (WHO) Strategic Advisory Group of Experts

(SAGE) on Immunization today issued recommendations on the use of the first licensed
dengue vaccine. SAGE recommends countries consider introduction of CYDTDV, also
known as Dengvaxia®, only in geographic settings (national or subnational) where
dengue is highly prevalent. SAGE recommends that vaccination should be considered as
an integrated strategy together with a communication strategy, well-executed and
sustained vector control, the best evidence-based clinical care for all patients with
dengue, and robust dengue surveillance.
Dengue, also known as “breakbone fever,” is the most common mosquito-borne
viral disease. Dengue causes about 390 million infections each year, putting at risk nearly
half of the world’s population. To date, no specific treatment for dengue exists.
Dengue vaccines have been under development since the 1940s. In late 2015 and
early 2016, the first dengue vaccine—Dengvaxia®, developed by Sanofi Pasteur—was
approved by Mexico, the Philippines, Brazil, El Salvador and Paraguay for use in
individuals 9-45 years old (9-60 years old in Paraguay) living in dengue-endemic areas.
The world’s first public dengue immunization program started this month in the
Philippines. Several other vaccine candidates are currently in clinical development, two
of which are in advanced stages.
The new recommendations resulted from the SAGE meeting held this week in
Geneva. SAGE consists of independent experts who advise the WHO on optimal use of
vaccines through an evidence-based review process. The age to target for vaccination to
maximize the reduction of dengue cases is projected to vary by transmission setting, but
it will likely fall between 9 and 14 years of age. Dengvaxia® is not recommended for use
in children under 9 years of age, consistent with the vaccine’s current labelling. These
and other SAGE recommendations can be found here.
As SAGE emphasized, introduction requires careful assessment by each country.
Such assessments should consider local priorities; national and subnational dengue
epidemiology; predicted impact and cost-effectiveness with country-specific
hospitalizations rates and costs; and affordability and budget impact.
If dengue vaccines are introduced, support for pharmacoviligance and post-
introduction studies will be essential to monitor and evaluate countries’ experiences.
Strategic communication will be critical for effective introduction and to inform partners
and stakeholders about lessons learned on the use of Dengvaxia®. DVI will continue
working to generate and disseminate evidence-based information that supports countries’
decisions on dengue vaccine introduction, as well as to raise the visibility of the
challenges and opportunities ahead in dengue prevention and control.
Decision: Registration Board considerd the expert opinions and basesd on their
recommendations and recommendations of WHO Strategic Advisory Group
of experts (SAGE) on 15th April 2016 approved the grant of registration of
DENGVAXIA, powder and solvent for suspension for Injection (Dengue
tetravalent vaccine (live, attenuated) manufactured by Sanofi Pasteur Parc
Industrial Incarville, 27100 Val de Reuil France and final release by M/s
Sanofi Pasteur NVL 31-33 quai Armand Barbes 69250 Neuville-sur-Saone
France, as per import policy. The firm shall provide the valid legalized CoPP
issued by the regulatory body of France. The Chairman Registration Board
shll allow the issuance of registration letter, if CoPP provided earlier than
the next meeting of Regiration Board.
Case No.22: MEASLES VACCINE BY NIH, ISLAMABAD
It is submitted that NIH, Islamabad has applied for registration of Measles Virus Vaccine live
attenuated (dried Injectable (Measles virus)
The Registratin Board Approved the request of Measles Virus Vaccine Live attenuated (dried
Injectable (Measles virus) in 256th Meeting of Registration Board. The Registration Board decided as
follows:
Decision of 256th RB: “Keeping in view the above mentioned discussion, Registratin board
approved the request of NIH, Islamabad for bulk import of measles vaccine concentrate from M/s Beijing
Minhai biotechnology co-operative Ltd, No.1, S1 Miao road, bio-engineering & Pharmacetical Industrial
park, Daxing district, Beijing, China and its local packing and labeling at NIH licensed facility for
manufacturing of measle vaccine for supply to EPI. The NIH shall arranghe the test/ analysis of first
batch from manufacturer at China and submit the reports to DRAP.”
Registratin Board also deliberated about the capacity of NIH for its installed facility where the
NIH was once manufacturingits own vaccine from the measles virus seed. NIH representatives were also
called to explain to the Registratin Board the circumstances under which the previous manufacturing
could not be carried out. The NIH is of view that the seed culture is got out of stock and no one has
showed its interest to supply the seed culture to NIH. The only way is import the bulkconcentrate from
china its local repacking at NIH facility. NIH claimed that all the manufacturing of measles vaccine shall
be for supply to EPI and its lot relaease will be through NCLB. The responsibility of quality, efficacy, and
safety shall be of NIH. EPI shall report AEFI of the said vaccine.
It is to mention that FSC & GMP provided by the NIH of aforementioned manufacturer
fromwhere they import bulk concentrate of measles vaccine, is of Combined Measles and Rubella
Vaccine, Live Injection, However, the product applied for registration is Measles Virus Vaccine live
attenuated (dried) Injectable. Since the submitted legalized documents are not align with information
contained on Form-5 for issuance of market authjorization (Registration Certificate) as approved by the
Registration board., Therefore the NIH was advised to submit clarification for measles bulk concentrate
manufacturing authorization of the manufacturer abroad approved by SFDA.
In reply the NIH has submitted statement leter issued by M/s Minhai biotechnology co. Ltd China:-

“ we hereby certify that we are allowed to produce andexport vaccines mentined in the drug
Manufacturing License, containing DTap-Hib vaccine, Live Attenuated combined vaccine of Measles and
rubella,dtap vaccine, Hib conjugate vaccine,freeze-dried conjugate vaccine, 23-valent Pneumococcal
Polysaccharide Vaccine, freeze-dried rabies vaccine for human use, small volume injectin and freeze-
dried powder.
According to Chinese GMP regulation, there is no speprate license for the production of
concentrate and bulk of vaccine, only the drug Manufactguring License of finsished product is available,
which is also the license for all intermediate products.”
Decision: Registration Board deliberated on all the aspects of contentiotion of the Biological
Division in lieu of previous decision of Registration Board. Technical Personels of NIH
also assued that also neccessay precautions shall be adopted to import only measle
vaccine concentrate, as SFDA has granted approval to M/s Beijing Minhai biotechnology
co-operative Ltd, No.1, S1 Miao road, bio-engineering & Pharmacetical Industrial park,
Daxing district, Beijing, China for manufacturing of Rubella and measle vaccine. The
Board finally reconfirmed its previous decision taken in 256th meeting and further
advised to take extra caution by NIH to confirm the import of only measles virus
concentrate and to avoid its mixing of rubella concentrate. The NIH shall also give
undertaking in this regard.

Item No.IV: Quality Assurance & Lab Testing Division.
Case No.01: Manufacture & Sale of Sub-Standard Drug-Metrozole Suspension Batch No.
09121508 By M/S Marvi Pharmaceuticals, Karachi. F. No. 3-01/2016-QC
The sample of Metrozole Suspension Batch No. 09121508 manufactured by

M/S Marvi Pharmaceuticals, Karachi drawn by FID Karachi from manufacturing premises on
21st December 2015 for test analysis. The sample was sent to the CDL Karachi, however the
sample was declared Substandard vide test report No.R.KQ.415/2015 dated 13th January 2016.
The result of CDL on the basis of which sample under reference has been declared sub-standard
is under:-
pH. Determined:- 4.0
Limits:- 5.6 to 6.5 Does not comply BP 2014
The sample is of “Sub-Standard” quality under the Drug Act 1976.
On the explanation letter to the firm by the FID Karachi the firm challenged the CDL
Test report in Appellate Laboratory NIH Islamabad under Section 22(5) of the Drugs Act 1976.
Result of Appellate Laboratory
pH:- Determined: 4.2 Limit:-5.0-6.5 Does not comply
Assay: Stated Found Limit Percentage
Metronidazole as 200mg/5ml 170.92mg/5ml 95.105% 85.46%

Metronidazole benzoate Does not comply with BP-2013
U/s 42 of the Drugs Act 1976, rules framed there under and The DRAP Act 2012 show
cause notices was issued to the firm and accused persons, offering opportunity of personal
hearing before the Drug Registration Board.
They have been called for personal hearing.
Decision: Mr. Pahlwan Tanvir, Plant Manager of the firm was appeared before the
Registration Board on29-06-2016 and pleaded their case. He stated before
the Board that there is some mistake in calculation in the report of Appellate
Laboratory, which if corrected their sample would be passed in assay. The
Honorable members of the Board after going through the said report found
that there seems some mistake which may be typographical but needs to be
clarified from the Appellate Laboratory (NIH ,Islamabad). The Board after

detailed discussion, deliberation, considering the facts and legal provision
decided to defer the case to get the clarification from the Appellate
Laboratory NIH Islamabad regarding the result of assay as percentage of
contents was written as 190.31 while found 170.92 in 5ml.
Case No.02: Manufacture and Sale of Substandard “Regnum Syrup” Batch No. 7297 By
M/s Novamed (Pvt) Ltd Lahore for M/s ICI Pakistan Limited , Karachi
The FID Karachi visited at the premises of M/s ICI Pakistan Limited 5-West Wharf Road,
Karachi on 19-03-2015. The FID took the sample of Regnum Syrup Batch No. 7297
Manufactured by M/s Novamed pharmaceuticals (Pvt) Ltd 28-Km Ferozpur Road Lahore, for the
test analysis and sent the above said sample to, CDL’s Karachi. However the FGA, declared the
sample as substandard quality vide its test report No.KQ.107/2015 dated 11th June 2015
Determined stated
Assay for amount/10ml: amount/10ml: Percentage:
Vitamin B2 1.482mg 1.2mg 123.5%

Limits 90.0% to 150.0% complies
Nicotinamide 11.721 mg 10.0mg 117.21%
Limits 90.0% to 150.0% complies
Vitamin C 17.61mg 50.0mg 35.22%
Limits 90.0% to 200.0% Does not comply
On explanation letter issued by the FID, the firm challenged the CDL report and requested for
Appellate Testing under Section 22(5) of Drugs Act, 1976. The Appellate Laboratory has also
declared the sample as Substandard vide their test report 025-MNHRS/2015 dated 22nd October
2015.
Assay:- Stated Found Limit

Percentage
Vitamin B1 1.5mg/10ml 1.80mg/10ml 90-200% 120.04%
Vitamin A 0.90mg/10ml 1.34mg/10ml 90-200% 148.94%
Vitamin C 50mg/10ml 26.317mg/10ml 90-200% 52.635%
Nicotinamide 10mg/10ml 13.123mg/10ml 90-150% 131.23%
Does not comply with manufacturers specification.

U/s 42 of the Drugs Act 1976, rules framed there under and The DRAP Act 2012 show cause
notices was issued to the firm and accused persons, offering opportunity of personal hearing
before the Drug Registration Board.
They have been called for personal hearing.
Decision: Mr. Muhammad Shahid Khan, Production Manager of the firm and Mr.
Muhammad Jhangir, Quality Control Manger of the firm was appeared
before the Registration Board on 29-06-2016 and pleaded their case. The
representative of the firm stated that Regnum Syrup contains multiple
ingredients in the formulation. As the product is in-house the testing method
is also in –house. For the analysis of vitamin “C” they use iodometry titration
and use of startch indicator by using preservative which is very critical to
visualize the end point of the result. The firm representatives stated that as
the formulation is liquid Glucose base which is very thick containing caramel
colour, so it is very hard to watch the end point. So they developed and
validated in- house method for the estimation of vitamin C. They stated that
the Government Lab may have used the Redox titration for the analysis of
vitamin C. The Board after detailed discussion, deliberation, considering the
facts and legal provision decided to conduct the Product specific inspection of
firm for complete investigation of case and confirming aforementioned
statement of firm by performing complete analysis of Regnum Syrup before
them.
i. Chairman Quality Control DRAP, Islamabad,
ii. DTL Lahore.
iii. Area FID
Panel will submit its report in 30 days time for consideration by Registration Board.
Case No.03:
Test Reports declared by Federal Government Analyst that the fate of sample may kindly be
decided under the guidance of Division of PE&R.
The Division of Quality Assurance DRAP Islamabad is receiving many reports from FGA, CDL
Karachi like some of the following cases
Federal Government Analyst does not declare the sample of such ingredients which are used in
both allopathic or non allopathic (or food supplement) allopathic drugs.
S.No. Name of Product Test Report and Identification Remarks of the

and manufacturer dated CDL
1. Osteo Calcium + R. LHR.222/2016 1) Calcium 1) The label
Calcium Plus dated 12th May identified claims Nutritional
Tablets 2016 Supplement
manufactured by 2.) Vitamin D
Zonex Pharma not identified 2) Vitamin D was

(Pvt) Ltd Lahore not identified as
suspected by the
Federal Inspector
of Drugs
concerned.
However Calcium
was found
340.68mg/tab
3.) The RDA

(adults) for
Calcium range is
1000-1200mg/day
hence the assay
result of Calcium
is below the limits
of the respective
RDA
4.) Since Calcium

is used in food
supplements as per
Pharmacopoeia
and also by the
allopathic
manufacturers as a
registered product
therefore the fate
of sample may
kindly be decided
under the guidance
of Directorate of
Registration
DRAP Islamabad
2. Nucal 600mg R.KQ.61/2016 1) Calcium The label claims

Tablets dated 27th April identified Natural Product
manufactured by 2016
M/s Pak 2.) Vitamin D 2) Assay result
Nutraceuticals not identified reveals that the
Karachi sample contains
calcium
400mg/tablet
3) Since Calcium
is used in food
supplements as per
pharmacopoeia
and also by the
allopathic
manufacturers as a
registered product
therefore the fate
of sample may

kindly be decided
under the guidance
of Directorate of
Registration
DRAP
3. Juvederm Tablet R.IP.86/2015 Alphatacopheral The label claims
manufactured by Vitamin E Natural product
identified
2.) Since
Ascorbic Acid not Alphatocopheral
identified Vitamin E is used
in food
supplements as per
Pharmacopoeia
and also by the
allopathic
manufacturer as a
registered product
therefore the fate
of sample may be
decided under the
guidance of
Directorate of
Registration
DRAP Islamabad
Decision: Registration Board deliberated that Division of Health & OTC, DRAP is functional
and after the promulgation of DRAP Act 2012 Natural, Nutritional, Herbal and Homeo products
etc come in the domain of aforementioned Division. Products referred by Government Analyst
are not registered by Registration Board, hence such references will be sent to Health and OTC
Division for deciding the matter
Case No.04: Manufacture & Sale of Sub-Standard Drug- Regogent Eye/Ear Drops Batch
.No. E-058 Mfd. by M/s Amros Pharmaceutical Karachi. (F. No. 03-39/2014-
QC)
Background of the case
The Assistant Drugs Controller (ADC), Karachi, Ms Ume Laila vide her letter date 15-
07-2014 intimated that she took the sample of the drug under reference from the export
consignment for Nigeria on 20-01-2014. It was further submitted that the drug sample has been
declared as of substandard quality by FGA, Central Drug Laboratory (CDL), Karachi vide its test
report No.EXP.19/2014, dated 14th July 2014. Salient features of the CDL test report are
reproduced as under
Assay for Gentamycin:
Determined amount %w/v: 0.2535%
Calculated amount %w/v: 0.3%

Percentage: 84.5%
Limits: 90.0% to 135.0% Does not comply.
Remarks:- The sample is of “Substandard” quality under the Drugs Act, 1976.
As per examination of documents submitted, it was evident that the drug sample under
reference was drawn by the ADC on 20-01-2014. However the CDL test report reflected that the
sample was received in the Lab on 12-06-2014 meaning thereby the sample was sent to the Lab
almost after four months and 21 days after its seizure for test/analysis. As per record of this
office, it was also apprised that Board Portion of sample has not been received in the QC
Section.
The ADC concerned was asked for explaining the reasons for not sending the sample to
the CDL Karachi and disposing off the Board’s portion with in 07 days vide letter dated 16-09-
2014.
In response, the ADC informed that the sample was delivered to the CDL on 20-01-2014
and acknowledgment receipt of CDL was furnished in this regard. The Director CDL also
confirmed vide reply dated 23-10-2014 that the sample was sent to the Lab by ADC Karachi
with Form-4 on 20-01-2014. However the stance of ADC regarding sending Board’s portion was
not correct as neither the Board’s portions of the samples nor Memorandum bearing No.UL-01-
03/2014-ADC(K) Export dated 20-01-2014 was not received in the Directorate of QA since
January 2014 to 31-10-2014. As per communication made by the ADC, it is very clear that the
mandatory provision of Section 19(3) of the Drugs Act 1976, and rules framed there under was
not followed. So the ADC was asked again as why the Board’s portion was not forwarded as per
above stated mandatory provision of the law
The ADC in response to this office letter dated 17-10-2014 sent retaining sample of the
drug under reference and stated that beside all misunderstanding and minor error of lower staff, I
am again sending the retaining sample of aforesaid batch which was available in her custody.
The view point of the ADC Karachi regarding sending Boards portion is not correct as no sample
as per memorandum bearing No. UL 01-03/2014-ADC (K)-Export date 20-01-2014 has been
received in Directorate of QA/LT Islamabad. The retaining sample sent by the ADC afterwards
and received by QC Section on 31-10-2014 is without memorandum and can not be entertained
as the same has not been forwarded with in mandatory 07 days time period as prescribed under
Section 19(3)(ii) of Drugs Act 1976.
The Director CDL was asked to comment on the delayed analysis of the sample of the
drug under reference sent/delivered to the Lab on 20-01-2014 as same should have been
analysed/reported within 60 days of the receipt of sample as required under Section 22(2) of
Drugs Act 1976. No extension in the testing period was sought from the competent authority as
per record of Directorate of QA/LT. The test report of the samples was issued on 14-07-2014 i.e.

05 months and 25 days after the receipt of sample by the Lab. It has also been stated that samples
from export consignment are liable to be charged for testing fee by CDL for test analysis. It was
also submitted that the date of receipt of testing fee is considered as the date of receipt of sample
as per policy framed after repeated observations by audit and public accounts committee of
National Assembly on outstanding testing fee. In the instant case the relevant voucher of testing
fee for the sample was submitted to CDL on 12-06-2014 therefore the same was mentioned as
the date of receipt of sample. It has been further stated that CDL tested and reported the drugs
sample under reference with in only one weak after receiving the sample with complete legal
formalities.
The Director CDL Karachi has not adhered to the above stated mandatory provision of Section
22(2) of Drugs Act 1976.
In the instant case the Board portion has not been received as required under Section
19(3) (ii) of the Drugs Act 1976 and the CDL test report has been issued after the laps of
mandatory time period. In view of above, it was therefore, proposed to place the case before the
Registration Board for consideration, direction and decision as the firm has challenged the CDL
test report under Section 22(4) of the Drugs Act 1976. The Board may also inquire further from
Director CDL Karachi and ADC Karachi on the issue.
The worthy Chairman Registration Board directed to bring the case before the Board for
discussion.
The case was placed before Drug Registration Board in its 248th meeting held on 19th
March 2015 but due to paucity of time the Board deferred the case till next meeting of the
Registration Board. The case was again submitted to the Board in its 249th meeting held on 19-
05-2015 for consideration and further directions in the matter.
Decision of 249th meeting:
Due to paucity of time the Board deferred the case till next meeting of the Registration Board
Decision: Registration Board deliberated the matter and advised QA&LT Division to
investigate the case and take appropriate action and inform Registration
Board accordingly.

Item no.V: Additional cases.
Case No.01: Writ Petition No.758/2015 and 4174/2015, Islamabad High Court.
Registration Board in 259th meeting deliberated decision of Islamabad High Court,

Islamabad in Writ Petition No.758/2015 and 4174/2015. Members were of the view that matter is
required to be discussed in detail with representative of M/o Law and Justice (Member
Registration Board) for opinion regarding registration of drug. Accordingly, decision in subject
petitions was deliberated in presence of representative of M/o Law and Justice. Registration
Board) was of the view that both petitions No. 758/2015 and 4174/2015 filed by the petitioner
M/s Everest Pharmaceuticals, Islamabad were disposed of by Islamabad High Court, Islamabad
vide a single order. The petitioner sought relief on the following five points: -
i. Declare that the drug Everlong is validly registered.

ii. The withdrawal of the registration of tablet Everlong may be declared as illegal and
without lawful authority.
iii. That the inspection of the premises, sealing of the tablet section of the premises/factory
be declared as without lawful authority and of no legal effect.
iv. That registration of FIR No. 12/2015 be declared as without lawful authority and of no
legal effect.
v. The Federal Investigation Agency be directed not to harass the petitioner or its staff.
Vide para 10 of the order, the Islamabad High Court has quashed the F.I.R’s, whereas
regards the withdrawal of registration, the Islamabad High Court has declared this writ petition
as infructuous on the ground that the matter of illegal withdrawal of registration is pending
before Lahore High Court vide writ petition No. 3200/2015.
In other words, the Islamabad High Court has granted relief to the petitioner on clauses
(iv) & (v) of the prayer and has left the decision on clauses (i), (ii) & (iii) upon Lahore High
Court.
The Registration Board in 260th meeting has decided to convey the relevant
quarters of DRAP to vigorously persue the case in Lahore High Court.

Case No.02: Deferred Case in 258th RB Meeting ZINNIA F (Levonorgestrel and Ethinylestradiol
Tables with Ferrous Fumarate Tablets) of M/s Hakimsons (Impex) Private Limited, Karachi
Sr. Name of Brand Name & Type of Form Document Decision in 258th
No Importer & Composition details (CoPP) meeting
Manufacturer Dy No & Date
of application Me too
status/New
Fee submitted molecule
Pack size/
Demanded
Price
1. M/s Hakimsons ZINNIA F Dy No. 1114 Legalized Deferred for expert
(Impex) Private (Levonorgestrel (R&I) DRAP CoPP dated 23- opinion by
Limited, Karachi and (TF) dated 29-9- 05-2014 following experts
Ethinylestradiol 2014 Legalized GMP and valid legalized
Tables with Certificate No. CoPP:
M/s Famy Care Ferrous Fee deposited: 1403070 dated
Limited Plot No. Fumarate Rs. 100000/- 05-3-2014 a. Brig ® Muzamil
1606-1609, Tablets) dated 04-9-2014 Hussain Najmi
G.I.D.C vide challan no. Free Sale Member
SARIGAM Strength of 0017217. Certificate No. Registration Board
396155, Dist. active ACV/Certi/
VALSAD, ingredient: For UNFPA/ Famy Care/ b. Brig.Amir Ikram,
GUJRAT, INDIA. Label Claim: USAID 2592/14 dated AFIP, Rawalpindi.
Each Sugar not for market. 21-4-2014
coated white c. Dr, Masud-ur-
tablet contains: Combi pack of Rehman, DDG,
Levonorgestrel 21 tablets of DRAP
Ph. Levonorgestrel
Eur……..150m &
cg ethinylestradiol
Ethinylestradiol & 7 tablets of
Ph. Eur……..30 ferrous fumarate
mcg
Ferrous
Fumarate
Tablets
Each Sugar
coated Brown
tablet contains:
Ferrous
fumarate

BP………75
mcg
(Equivalent to
Ferrous
iron…24.375m
g)
Pharmacologica
l group:
Hormonal
Contraceptives.
ATC
Classification:
G03AA07.
It is submitted that in the 258th meeting of Registration Board following of the experts of the decided by
the Board.
1. Prof Dr. Sayeda Batool, MCH, PIMS Islamabad.

2. Col.Dr. Abeera Ch. MH, Rawalpindi.
3. Prof Dr. Nasira , PIMS, Islamabad
The above experts were also mentioned in the final draft minutes of 258th RB communicated to Secretary,
Registration Board. However they were in advertently replaced by the experts as mentioned in the last
column of the agenda item and also in the decision of the Board.
Decision: Registration Board approved following relevant experts :

a. Prof Dr. Sayeda Batool, MCH, PIMS Islamabad.
b. Col.Dr. Abeera Ch. MH, Rawalpindi.
c. Prof Dr. Nasira , PIMS, Islamabad
Registration Board deferred rest of agenda due to paucity of time.
Meeting ended with a vote of thanks to and from the chair.
End of Document
*************************************************************************

Minutes For 260 Meeting Registration Board Held On 28-29 June, 2016

Uploaded by

Copyright:

Available Formats

Minutes For 260 Meeting Registration Board Held On 28-29 June, 2016

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Minutes For 260 Meeting Registration Board Held On 28-29 June, 2016

Uploaded by

Copyright:

Available Formats

Minutes for 260th Meeting Registration Board held on 28-29th June, 2016.

Item No. Detail of Item Page No(s)

Item No.I Confirmation for minutes of 259th Registration Board meeting 04

Item No.II Pharmaceutical Evaluation & Registration Division 05 - 375

Item No.III Biological Drugs Division 376 - 483

Item No.V Additional cases 491 - 493

Minutes for 260th Meeting Registration Board 1

1. Lt General (R) Karamat Ahmed Karamat. Member

2. Brig (R). Dr. Muzammil Hasan Najmi, Member

4. Sheikh Sarfraz Ahmad Member

Minutes for 260th Meeting Registration Board 2

Dr.Muhammad Khalid Khan attended the meeting on 28.06.2016 while Dr.Muhammad

Dr.Masud-ur-Rehman (DDG Biological), Zaheer-ud-Din M Babar (DDC R.I/R IV),

In addition to routine agenda, following was also discussed and decided:

Minutes for 260th Meeting Registration Board 3

 Dr.Amanullah Khan, Director DTL, Quetta:

It may be decided as per decision of Registration Board.

 Dr.Noor Muhammad Shah, Director Medical Device, DRAP:

Decision: Registration Board deliberated that points observed by Director Medical

Minutes for 260th Meeting Registration Board 4

Registration Board in 258th meeting considered following proposal of Dr.Muhammad

S.No Name of Drug & Composition No of applicants / manufacturers

In 259th meeting, Registration Board decided as follows:

Minutes for 260th Meeting Registration Board 5

 Punjab: Director DTL Lahore; Director DTL Peshawar and

Registration Board also approved above panels for confirmation genuineness/

 Sind and Balochistan: Director DTL Quetta (Chairman), Director DTL

Case No.02: Price fixation under the Drug Pricing Policy-2015.

Minutes for 260th Meeting Registration Board 6

It is not a new chemical entity. Reference price is neither available

 Imported by Pfizer Demanded price of Sayana Press Injection @ Rs.1078/- per

Minutes for 260th Meeting Registration Board 7

It is not a new chemical entity. Reference price is neither available

It is not a new chemical entity. Reference price is neither available

Minutes for 260th Meeting Registration Board 8

It is not a new chemical entity. Reference price is neither available

Minutes for 260th Meeting Registration Board 9

Case No.03: Renewal of registered drug and Post-registration variation approval.

Minutes for 260th Meeting Registration Board 10

a. M/s Prix Pharma Lahore.

S. Reg/No Products/Name Initial Date of Application receiving

Decision: Firm submitted renewal application within 60 days of expiry period of

S. Reg/No Products/Name Date of Application receiving date

Minutes for 260th Meeting Registration Board 11

S. Reg/No Products/Name Initial Date Application receiving date

S. Reg/No Products/Name Initial Date Application receiving

Minutes for 260th Meeting Registration Board 13

Minutes for 260th Meeting Registration Board 14

29 009353 Kotria tablet do Do

30 004328 Paracambind tablet do Do

31 010577 Clean Skin Solution do Do

Minutes for 260th Meeting Registration Board 15

Decision: Firm submitted renewal application within 60 days of expiry period of

S. Reg/No Products/Name Initial Date of Application receiving

Decision: Firm submitted renewal application within 60 days of expiry period of

Minutes for 260th Meeting Registration Board 16

Case No.05: Request for change of manufacturer of Kefei ® Injection (Reg.No.059054) by

M/s. RG Pharmaceutical (Pvt) Ltd., Karachi had applied for change of

Decision: Registration Board advised to provide evidence of approval of the drug