Granules India gets US FDA approval for generic Mitigare capsules

Granules India gets US FDA approval for generic Mitigare capsules

By, Admin 2 May 2024

Overview

Granules India received the US Food & Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA). This was 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 indication:- Colchicine capsules are indicated for prophylaxis of gout flares in adults.

Approvals

Granules now have a total of 64 ANDA approvals from the US FDA. Of these 63, are final approvals and one is a tentative approval.

Current annual sale

The current annual US market for colchicine capsules is approximately $55 million, according to MAT February 2024, IQVIA/IMS Health.

Granules India

  • The Hyderabad-based Granules India set up in 1991 is a vertically integrated pharmaceutical company with advanced facilities.
  • The company said that it is one among the few 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).

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