Granules India Limited announced today 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 (Hikma).

Colchicine Capsules are indicated for prophylaxis of gout flares in adults.

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.