Granules India arm gets USFDA nod for Gout flares drug Colchicine
Colchicine Capsules are indicated for prophylaxis of gout flares in adults.
Hyderabad: Granules India Limited today announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company, for Colchicine Capsules, 0.6 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD),...
Hyderabad: Granules India Limited today announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company, for Colchicine Capsules, 0.6 mg.
It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mitigare Capsules, 0.6 mg of Hikma International Pharmaceuticals LLC.
Colchicine Capsules are indicated for prophylaxis of gout flares in adults. Gout flares refer to sudden and intense episodes of pain, swelling, redness, and warmth in the joints, typically caused by the buildup of uric acid crystals. These flares often occur in the big toe but can also affect other joints such as the ankles, knees, elbows, wrists, and fingers.
Granules now have a total of 64 ANDA approvals from the US FDA (63 Final approvals and 1 tentative approvals). The current annual U.S. market for Colchicine Capsules is approximately $55 Million, according to MAT Feb 2024, IQVIA/IMS Health.
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Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The Company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ 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 USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
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