Granules receives USFDA nod for Prazosin Hydrochloride capsules

Hyderabad: Granules Pharmaceuticals Inc (GPI), a wholly owned foreign subsidiary of Hyderabad-based Granules India, received the US Food & Drug Administration (US FDA) approval for the Abbreviated New Drug Application (ANDA) for Prazosin Hydrochloride Capsules, USP 1mg, 2mg and 5mg. It is bioequivalent to the reference listed drug product (RLD), Mini plus capsules 1Mg, 2Mg […]

Hyderabad: Granules Pharmaceuticals Inc (GPI), a wholly owned foreign subsidiary of Hyderabad-based Granules India, received the US Food & Drug Administration (US FDA) approval for the Abbreviated New Drug Application (ANDA) for Prazosin Hydrochloride Capsules, USP 1mg, 2mg and 5mg.

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

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

Granules now has a total of 46 ANDA approvals from US FDA (44 final approvals and two tentative approvals).

The current annual US market for Prazosin Hydrochloride 1mg, 2mg and 5mg strengths is approximately $54 million, according to IQVIA/IMS Health.

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