2Q1h November, 2018, Vadodara, India

PRESS RELEASE 2Q1h November, 2018, Vadodara, India Alembic Pharmaceuticals receives USFDA Approval for Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg. Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food & Drug·Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Orally Disintegrating Tablets, 10 mg (base). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Staxyn® Orally Disintegrating Tablets, 10 mg, of Bayer Healthcare Pharmaceuticals, Inc. Vardenafil Hydrochloride Orally Disintegrating Tablets are indicated for the treatment of erectile dysfunction. Alembic had previously received tentative approval for this ANDA. Vardenafil Hydrochloride Orally Disintegrating Tablets, 1 O mg, have an estimated market size of US$ 8 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 78 ANDA approvals (65 final approvals and 13 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 m~ny 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 the company can be found at http://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLL TD) (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 REG~. OFFICE : ALE~ BIC ROAD, VADODARA - 390 003. • TEL : (0265) 2280550, 22~0880 • FAX : (0265) 2281229 website: www.alemb1cpharmaceuticals.com •.E-mail: [email protected] • CIN: L24230GJ2010PLC061123

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