Glenmark Pharmaceuticals gets USFDA’s final approval for Saxagliptin Tablets

01 Aug 2023 Evaluate

Glenmark Pharmaceuticals has received final approval from the United States Food & Drug Administration (USFDA) for Saxagliptin Tablets, 2.5 mg and 5 mg, the generic version of Onglyza 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 market achieved annual sales of around $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 USFDA. 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.  

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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