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Glenmark Pharmaceuticals Receives ANDA Tentative Approval for Dapagliflozin and Saxagliptin Tablets, 10 mg/5 mg


Press Trust of India MUMBAI
/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dapagliflozin and Saxagliptin Tablets, 10 mg/5 mg, the generic version of Qtern1 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.
1 All brand names and trademarks are the property of their respective owners.
2 Market includes brand and all available therapeutic equivalents

* IQVIA National Sales Perspectives: Retail & Non-Retail, February 2020

About Glenmark Pharmaceuticals

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


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First Published: Apr 29 2020 | 1:31 PM IST

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