Glenmark Pharmaceuticals receives ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg

Bangalore, India and Mahwah, New Jersey,2nd August 2023: Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led, integrated, global pharmaceutical company has received final approval by the United States Food & Drug Administration (U.S. FDA) for Saxagliptin Tablets, 2.5 mg and 5 mg, the generic version of Onglyza®1 Tablets, 2.5 mg and 5 mg, of AstraZeneca AB. Glenmark’s Saxagliptin Tablets, 2.5 mg and 5 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.

According to IQVIATM sales data for the 12-month period ending June 2023, the Onglyza® Tablets, 2.5 mg and 5 mg market2 achieved annual sales of approximately $100.7 million*.

Glenmark’s current portfolio consists of 184 products authorized for distribution in the U.S. marketplace and 49 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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