Granules India bags USFDA nod for Prazosin Hydrochloride capsules

The United States Food & Drug Administration has approved the Abbreviated New Drug Application filed by Granules Pharmaceuticals, Inc., a wholly owned foreign subsidiary of Granules India, for Prazosin Hydrochloride capsules, USP 1mg, 2mg & 5mg.

Prazosin Hydrochloride capsules, USP (in the strengths of 1mg, 2mg & 5mg) is bioequivalent to the reference listed drug product (RLD), mini plus capsules 1 mg, 2 mg & 5 mg of Pfizer Inc. The product would be available for the US market shortly.

Currently, Granules India has a total of 46 ANDA approvals from USFDA (44 final approvals and 2 tentative approvals). The current annual U.S. market for Prazosin Hydrochloride 1mg, 2mg, 5mg strengths is approximately $54 million, according to IQVIA/IMS Health.

Granules India's consolidated net profit dropped 50.7% to Rs 80.68 crore on a 3.5% increase in net sales to Rs 888.33 crore in Q2 FY22 over Q2 FY21.

Shares of Granules India rose 0.44% to Rs 341.65 on BSE. Granules India is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad.

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