Alembic Pharmaceuticals receives USFDA approval for Nifedipine Extended-Release Tablets

Alembic Pharmaceuticals 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 90mg, of Pfizer Inc.

Nifedipine Extended-Release Tablets are indicated for the management of i) Vasospastic Angina ii) Chronic Stable Angina (Classical Effort Associated Angina) and iii) 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 Sep 2022 according to IQVIA.

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