Granules India’s wholly owned foreign subsidiary - Granules Pharmaceuticals, Inc (GPI) has received US Food & Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) 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 (Hikma). Colchicine Capsules are indicated for prophylaxis of gout flares in adults.
Granules now have a total of 64 ANDA approvals from the USFDA (63 Final approvals and 1 tentative approvals). The current annual U.S. market for Colchicine Capsules is around $55 Million, according to MAT February 2024, IQVIA/IMS Health.
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).
