Granules India has announced that its a wholly owned foreign subsidiary, Granules Pharmaceuticals, Inc (GPI), received the US Food & Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for penicillamine capsules USP, 250 mg.
It is bioequivalent to the reference listed drug product (RLD), Cuprimine of Bausch Health Americas, Inc. 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 which covers 33 final approvals and 2 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.