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).
