The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI), a wholly-owned foreign subsidiary of Granules India, for Penicillamine capsules USP, 250 mg.
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.The drug is bio-equivalent to the reference listed drug (RLD) product, 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.
According to IQVIA Health, Penicillamine capsules had U.S. sales of approximately $67 million for the most recent twelve months ending in October 2020.
Granules India is a pharmaceutical manufacturing company. The company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice. The company has now a total of 35 ANDA approvals from US FDA (33 final approvals and 2 tentative approvals).
On a consolidated basis, Granules India reported 70.8% jump in net profit to Rs 164 crore on a 22.7% rise in income from operations to Rs 858 crore in Q2 FY21 over Q2 FY20.
Shares of Granules India fell 0.64% at Rs 419.45 on Thursday.
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