Granules India Ltd. has declared 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 US market for Colchicine Capsules is approximately USD 55 Million, according to MAT Feb 2024, IQVIA/IMS Health.

Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service. The company 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). Our 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, the US, and the UK.