Granules India Limited announced today that the US Food & Drug Administration (US FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, generic equivalent of Glumetza ER Tablets, 500 mg and 1000 mg, of Bausch Health US LLC (Bausch).
Metformin Hydrochloride ER Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin Hydrochloride ER Tablets had U.S. sales of approximately $192 million for the most recent twelve months ending in November 2020 according to IQVIA Health.
Granules now has a total of 35 ANDA approvals from US FDA (34 Final approvals and 1 tentative approval).
Glumetza is a trademark of Salix Pharmaceuticals, Inc. or its affiliates.
Shares of GRANULES INDIA LTD. was last trading in BSE at Rs.368.4 as compared to the previous close of Rs. 361.5. The total number of shares traded during the day was 71091 in over 2974 trades.
The stock hit an intraday high of Rs. 371.75 and intraday low of 360.15. The net turnover during the day was Rs. 26096250.