Granules India gets US FDA approval for Penicillamine Capsules

Granules India announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals (GPI), a wholly-owned foreign subsidiary of Granules India, for Penicillamine Capsules USP, 250 mg. It is bioequivalent to the reference listed drug product (RLD), Cuprimine of Bausch Health Americas. The product would be manufactured at Granules manufacturing facility in Chantilly, Virginia and is expected to be launched shortly.

Penicillamine Capsules are indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.

Granules now has a total of 35 ANDA approvals from US FDA (33 final approvals and two tentative approvals).

Penicillamine Capsules had US sales of approximately $67 million for the most recent twelve months ending in October 2020 according to IQVIA Health.

Cuprimine is a trademark of Bausch Health Companies or its affiliates.