05th December, 2018, Vadodara, India

PRESS RELEASE 05th December, 2018, Vadodara, India Alembic Pharmaceuticals receives USFDA Approval for Candesartan Cilexetil Tab!ets USP, 4 mg, 8 mg, and 16 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) Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Atacand Tablets, 4 mg, 8 mg, and 16 mg, of ANI Pharmaceuticals, Irie. Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Candesartan cilexetil tablets also indicated for the treatment of heart failure. Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg, hzve an estimated market size of US$ 22 million for twelve months ending December 2017 according to IQVIA. Alembic has a cumulative total of 82 ANDA approvals (69 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 many developed countries including the USFDA. Alembic is one of the leaders in branded generics in lncfia. 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 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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