Glenmark Pharmaceuticals gets tentative ANDA nod for Dapagliflozin Tablets
Mumbai: 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.
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 in the world in terms of revenue.