Alembic Pharmaceuticals receives USFDA Final Approval for Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg

Alembic Pharmaceuticals Limited (Alembic) 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 i) Vasospastic Angina ii) Chronic Stable Angina (Classical EffortAssociated Angina) and iii) Hypertension. Refer to our label for full indication.

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.

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

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 625.35 as compared to the previous close of Rs. 635.20. The total number of shares traded during the day was 4275 in over 670 trades.

The stock hit an intraday high of Rs. 635.00 and intraday low of 620.05. The net turnover during the day was Rs. 2672177.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA Nifedipine ExtendedReleaseTablets