Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olmesartan Medoxomil and Amlodipine Tablets, 20 mg/5 mg, 40 mg/5 mg, 20 mg/10 mg, and 40 mg/10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Azor Tablets, 20 mg/5 mg, 40 mg/5 mg, 20 mg/10 mg, and 40 mg/10 mg, of Daiichi Sankyo Inc.
Olmesartan Medoxomil and Amlodipine Tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents to lower blood pressure. According to IMS, these tablets have an estimated market size of $ 312 million for twelve months ending December 2016. The company now has a total of 61 ANDA approvals (53 final approvals and 8 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.
