Granules India has announced that its an entirely 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 merchandise would be manufactured at Granules manufacturing facility in Chantilly, Virginia and is predicted to be launched shortly.
Penicillamine capsules are indicated within the treatment of hepatolenticular degeneration , cystinuria, and in patients with severe, active atrophic arthritis who have did not answer an adequate trial of conventional therapy.
Granules now features a total of 35 ANDA approvals from US FDA which covers 33 final approvals and a couple of tentative approvals.
Penicillamine capsules had US sales of roughly $67 million for the foremost recent twelve months ending in October 2020 consistent with IQVIA Health.
About Granules India :
Granules India Limited is an Indian pharmaceutical manufacturing company based in Hyderabad, India. Granules manufactures several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on an outsized scale for patrons within the regulated and remainder of the planet markets. Granules India Limited entered CRAMS segment, which focuses on contract research and manufacturing