Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Procardia XL Extended-Release Tablets, 30 mg, 60 mg and 90 mg, of Pfizer Inc. Nifedipine Extended-Release Tablets are indicated for the management of: Vasospastic Angina; Chronic Stable Angina (Classical Effort- Associated Angina); and Hypertension.

Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg, have an estimated market size of US $56 million for twelve months ending September 2022 according to IQVIA.

Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 tentative approvals) from USFDA.

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare. 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 India. Alembic's brands, marketed through a marketing team of over 5,000 are well recognized by doctors and patients.