MUMBAI, India — Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for metformin hydrochloride extended-release tablets USP, 500 mg and 1000 mg, the generic version of Glumetza Extended-Release Tablets, 500 mg and 1000 mg, of Salix Pharmaceuticals Inc.

According to IQVIA sales data for the 12-month period ending September 2019, the Glumetza Tablets, 500 mg and 1000 mg market2 achieved annual sales of approximately $226.7 million. Glenmark’s current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the U.S. FDA.