Alembic Pharmaceuticals gets USFDA approval for Nifedipine Tablets

21 Nov 2022 , 02:01 PM

Alembic Pharmaceuticals Limited announced that it has received final USFDA approval for its Abbreviated New Drug Application (ANDA) Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg, and 90 mg.

The ANDA approved by the USFDA is therapeutically equivalent to Pfizer Inc.’s Procardia XL Extended-Release Tablets, 30 mg, 60 mg, and 90 mg.

Nifedipine Extended-Release Tablets are used to treat Vasospastic Angina, Chronic stable angina (classical effort-associated angina), and hypertension, stated the company in its media filing.

According to IQVIA, the market for Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg, and 90 mg is worth US$ 56 million in the twelve months ending September 2022.

Alembic has received a total of 177 ANDA approvals from the USFDA which includes 153 final approvals and 24 tentative approvals.

At around 2.04 PM, Alembic Pharmaceuticals was trading at Rs627.65 up by 0.37% from its previous closing of Rs625.35 on the BSE. The scrip touched intraday high and low of Rs634.70 and Rs617.05 respectively.

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