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Alembic Pharma gets USFDA nod for Telmisartan, Amlodipine Tablets

18 Nov 2016 Evaluate

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Telmisartan and Amlodipine Tablets, 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Twynstao Tablets, 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.

Telmisartan and Amlodipine Tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents to reduce blood pressure. The company now has a total of 50 ANDA approvals (44 final approvals and 6 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.

Alembic Pharma Share Price

766.70 3.15 (0.41%)
22-Apr-2026 10:45 View Price Chart
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