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.
