Granules India’s arm gets ANDA approval from USFDA for Prazosin Hydrochloride Capsules

28 Dec 2021 Evaluate

Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc. (GPI), has received Abbreviated New Drug Application (ANDA) approval from US Food & Drug Administration (USFDA) 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.

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.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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