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Granules India’s arm gets USFDA nod for generic Penicillamine capsules

04 Dec 2020 Evaluate

Granules India’s wholly-owned foreign subsidiary -- Granules Pharmaceuticals Inc, has received approval for its abbreviated new drug application (ANDA) for Penicillamine capsules USP, 250 mg from the US Food and Drug Administration (USFDA). 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 withsevere, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

 

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