Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by 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.
Onglyza Tablets, 2.5 mg and 5 mg achieved annual sales of around $518.5 million for the 12 month period ending April 2017.
The company’s current portfolio consists of 117 products authorized for distribution in the U.S. marketplace and 68 ANDA’s pending approval with the USFDA. In addition to these internal filings, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
