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.
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 (33 Final approvals and 2 tentative approvals).
Penicillamine Capsules had U.S. sales of approximately $67 million for the most recent twelve months ending in October 2020 according to IQVIA Health.
Cuprimine ® is a trademark of Bausch Health Companies Inc. or its affiliates.
Shares of GRANULES INDIA LTD. was last trading in BSE at Rs.419.45 as compared to the previous close of Rs. 422.15. The total number of shares traded during the day was 57668 in over 2391 trades.
The stock hit an intraday high of Rs. 425 and intraday low of 416.65. The net turnover during the day was Rs. 24230295.