Enforcement Report - Week of December 20, 2023
Sun Pharma, Lupin recall drugs in US on manufacturing woes
Cuvrior, the Orphalan treatment for adult patients with stable Wilson’s disease, has gotten approval from the FDA.
Navinta`s Generic Penicillamine Receives Approval in US
Aggrega's Generic Penicillamine Receives Approval In the US
Invagen Pharms' generic Penicillamine receives approval in US
Global pharma major Lupin Limited announced the launch of the United States Food and Drug Administration (FDA) approved penicillamine tablets USP, 250 mg.
Granules Pharma`s Generic Penicillamine Receives Approval In US
Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India Limited, 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.
Pharma major Lupin Limited (Lupin) announced that it has received approval for its Penicillamine Tablets USP, 250 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Depen® Tablets, 250 mg, of Mylan Specialty, L.P. The product would be manufactured at Lupin’s Nagpur facility and is expected to be launched shortly.