Skip to main content

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

 

Clinical courses

 

Clinical research courses

Glenmark Pharma receives ANDA approval for Saxagliptin Tablets

Glenmark Pharmaceuticals Ltd. is an integrated, research‐led, global pharmaceutical company, with a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology.

Glenmark Pharmaceuticals Ltd 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 Onglyza1 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 USD

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.