Granules India gets ANDA approval for Colchicine capsules

Granules India has received approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, 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 (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 US market for Colchicine Capsules is approximately $55 million, according to MAT Feb 2024, IQVIA/IMS Health