Glenmark Pharmaceuticals gets USFDA Tentative nod for Dapagliflozin, Saxagliptin Tablets
Mumbai: Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & Drug Administration for Dapagliflozin and Saxagliptin Tablets, 10 mg/5 mg, the generic version of Qtern®1 Tablets, 10 mg/5 mg, of AstraZeneca AB.
According to IQVIA™ sales data for the 12 month period ending February 2020, the Qtern® Tablets, 10 mg/5 mg market2 achieved annual sales of approximately $10.4 million*.
Glenmark's current portfolio consists of 162 products authorized for distribution in the U.S. marketplace and 44 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 Ltd. (GPL) is a global research-led pharmaceutical company headquartered in Mumbai, India. The Company was founded in 1977 by Gracias Saldanha.
Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.
Its branded generics business has a significant presence in markets across emerging economies including India.
The Company's API business sells products in over 65 countries including the US, various countries in the EU, South America and India.