The ANDA for Colchicine Capsules was filed by the company’s wholly owned foreign subsidiary Granules Pharmaceuticals, Inc. (GPI).

The approved drug is a bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Mitigare Capsules of Hikma International Pharmaceuticals LLC (Hikma).

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

The current annual U.S. market for Colchicine Capsules is approximately $55 Million, according to MAT Feb 2024, IQVIA/IMS Health.

"Granules now have a total of 64 ANDA approvals from the US FDA (63 Final approvals and 1 tentative approvals),” the company said in a statement.

Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).

The pharma company's consolidated net profit rose 1.06% to Rs 125.65 crore on 0.82% increase in revenue from operations to Rs 1,155.58 crore in Q3 FY24 over Q3 FY23.