Sub: Alembic Pharmaceuticals Receives USFDA Tentative Approval For Empagliflozin and Linagliptin Tablets, 10 mg/5 MG and 25 mg/5 MG

Date: 27th August, 2020
To,
The Manager,
Department of Corporate Services,
BSE Limited
P. J. Towers, Dalal Street,
Fort, Mumbai – 400 001
Dear Sir/Madam,
Sub: Alembic Pharmaceuticals receives USFDA Tentative Approval for

Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg.
With reference to the captioned subject, this is to inform the exchange that the
Company has received US Food & Drug Administration (USFDA) Tentative Approval
for Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg.
Please find enclosed herewith our press release.
We request you to kindly take the same on record.
Thanking you,
Yours faithfully,
For Alembic Pharmaceuticals Limited
Digitally signed by
CHARANDEEP CHARANDEEP
SALUJA
SINGH
SINGH SALUJA Date: 2020.08.27 10:12:45

+05'30'
Charandeep Singh Saluja

Company Secretary
Encl.: A/a.
ALEMBIC PHARMACEUTICALS LIMITED

REGD. OFFICE : ALEMBIC ROAD, VADODARA - 390 003. ● TEL : (0265) 2280550, 2280880 ● FAX : (0265) 2281229
website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123
PRESS RELEASE
27th August, 2020, Vadodara, India
Alembic Pharmaceuticals receives USFDA Tentative Approval for Empagliflozin and

Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg.
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative
approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug
Application (ANDA) Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg. The
tentatively approved ANDA is therapeutically equivalent to the reference listed drug product
(RLD), Glyxambi Tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim
Pharmaceuticals, Inc. (Boehringer). Empagliflozin and Linagliptin Tablet is indicated as an
adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
when treatment with both Empagliflozin and Linagliptin is appropriate. Empagliflozin is
indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and
established cardiovascular disease. However, the effectiveness of Empagliflozin and
Linagliptin Tablets on reducing the risk of cardiovascular death in adults with type 2 diabetes
mellitus and cardiovascular disease has not been established.
Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg have an estimated market
size of US$ 244 million for twelve months ending June 2020 according to IQVIA. Alembic is
currently in litigation with Boehringer in District Court of Delaware and launch of the product
will depend on litigation outcome.
Alembic now has a total of 130 ANDA approvals (113 final approvals and 17 tentative
approvals) from USFDA.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development

pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered
in India, Alembic is a publicly listed company that manufactures and markets generic
pharmaceutical products all over the world. Alembic's state of the art research and
manufacturing facilities are approved by regulatory authorities of many developed countries
including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's
brands, marketed through a marketing team of over 5000 are well recognized by doctors and
patients.
Information about Alembic can be found at http://www.alembicpharmaceuticals.com/;

(Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE: 533573)
For more information contact:

Ajay Kumar Desai Mitanshu Shah
Phone: +91 22 - 306 11681 Phone: +91 265 - 3007630
Email: [email protected] Email: [email protected]
ALEMBIC PHARMACEUTICALS LIMITED

REGD. OFFICE : ALEMBIC ROAD, VADODARA - 390 003. ● TEL : (0265) 2280550, 2280880 ● FAX : (0265) 2281229
website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123

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Date: 27th August, 2020

Sub: Alembic Pharmaceuticals receives USFDA Tentative Approval for

Please find enclosed herewith our press release.

We request you to kindly take the same on record.

SINGH SALUJA Date: 2020.08.27 10:12:45

Charandeep Singh Saluja

ALEMBIC PHARMACEUTICALS LIMITED

27th August, 2020, Vadodara, India

Alembic Pharmaceuticals receives USFDA Tentative Approval for Empagliflozin and

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, a vertically integrated research and development

Information about Alembic can be found at http://www.alembicpharmaceuticals.com/;

For more information contact:

Phone: +91 22 - 306 11681 Phone: +91 265 - 3007630

Email: [email protected] Email: [email protected]

ALEMBIC PHARMACEUTICALS LIMITED

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