Alembic Pharmaceuticals on Monday said that it has received the United States Food and Drug Administration’s (USFDA) final approval for Nifedipine extended-release tablets USP, 30 mg, 60 mg, and 90 mg.
Nifedipine tablets are used to treat cardiac and circulatory disorders like Vasospastic Angina, Chronic Stable Angina, and Hypertension.
The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product, Procardia XL extended-release tablets, 30 mg, 60 mg, and 90 mg, of Pfizer Inc.
According to IQVIA data, Nifedipine extended-release tablets USP, 30 mg, 60 mg, and 90 mg, have an estimated market size of $56 million for 12 months that ended in September 2022.
Earlier this month, Alembic Pharma received approval from the USFDA for Cyclophosphamide Capsules, Ketorolac Tromethamine Injection USP, Glycopyrrolate Injection USP, and Mesalamine Extended capsules.
The pharma company has a cumulative total of 177 ANDA approvals, including 153 final approvals and 24 tentative approvals, from USFDA.
RK Baheti, CFO of Alembic Pharma told CNBC-TV18 that the lower-than-expected performance was because the US margins have been under pressure.
Baheti further added that the company would be happy with $45-50 m revenue in the US every quarter.
Shares of Alembic Pharma ended little changed at Rs 625.95.
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