Granules India secures USFDA nod for Prazosin Hydrochloride Capsules

Hyderabad: Granules India Limited announced today that the US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India Limited, for Prazosin Hydrochloride Capsules, USP 1mg, 2mg & 5mg.

It is bioequivalent to the reference listed drug product (RLD), Mini plus capsules 1Mg, 2Mg & 5 Mg of Pfizer Inc. The product would be available for the US market shortly.

Prazosin is an antihypertensive medicine which is used to treat high blood pressure and Benign Prostatic Hypertrophy (prostate enlargement).

Commenting on the approval Ms. Priyanka Chigurupati, Executive Director, GPI, said "We are pleased to receive the approval of the product and will surely be a valuable addition to our growing product portfolio in the US market."

Granules now has a total of 46 ANDA approvals from US FDA (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.

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Granules India is an Indian pharmaceutical manufacturing company that was founded in 1984 named as Triton Laboratories located in Hyderabad, India.

Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets.

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