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Alembic Pharmaceuticals Limited has announced that it has received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg.
USFDA approved ANDA therapeutically approved by Pfizer Inc. equivalent to the company’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 (classic exertional angina) and hypertension, the company said in a media release.
According to IQVIA, the market for Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg and 90 mg is expected to reach USD 56 million in the twelve months ending September 2022.
Alembic has received a total of 177 ANDA approvals from the USFDA, including 153 final and 24 tentative approvals.
At around 2.04 pm, Alembic Pharmaceuticals was trading at Rs 625.35, up 0.37% from its previous close at Rs 627.65. The scrip touched an intraday high and low of Rs634.70 and Rs617.05 respectively.
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