Granules Pharmaceuticals receives ANDA approval for Prazosin Hydrochloride Capsules
Hyderabad-based Granules India Limited today announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI) for Prazosin Hydrochloride Capsules, USP 1mg, 2mg & 5mg.
Hyderabad-based Granules India Limited today announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI) 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 Pharmaceuticals, Inc. (GPI) is a wholly-owned foreign subsidiary of Granules India Limited.
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 have a total of 46 ANDA approvals from the 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.
Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad. It is equipped with best in class facilities and a commitment to operational excellence, quality, and customer service. It is among the few pharmaceutical companies in the world to be present in the manufacturing of the entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs).
Products of Granules India is distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 75+ countries with offices across India, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.