Glenmark Pharmaceuticals’ fully owned subsidiary -- Glenmark Pharmaceuticals Inc., USA (Glenmark) has received a 2nd tentative 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 Tablets, 2.5 mg and 5 mg, of AstraZeneca AB. Glenmark’s first tentative approval letter for Saxagliptin Tablets, 2.5 mg and 5 mg was received on June 12, 2017.
According to IQVIATM sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $122.3 million. Glenmark’s current portfolio consists of 179 products authorized for distribution in the U.S. marketplace and 46 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.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
