Glenmark Pharmaceuticals receives ANDA tentative approval for Dapagliflozin Tablets, 5 mg and 10 mg
Mumbai, India; March 23, 2020: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dapagliflozin Tablets, 5 mg and 10 mg, the generic version of Farxiga®1 Tablets, 5 mg and 10 mg, of AstraZeneca AB.
According to IQVIATM sales data for the 12 month period ending January 2020, the Farxiga® Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately $1.8 billion*.
Glenmark’s current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 45 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.
1All brand names and trademarks are the property of their respective owners.
2Market includes brand and all available therapeutic equivalents
*IQVIATM National Sales Perspectives: Retail & Non-Retail, January 2020
About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). For more information, visit www.glenmarkpharma.com
Madhurima Gupta Jain
Senior Manager, Corporate Communications
+91 22 4018 9606