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Glenmark Pharmaceuticals receives ANDA tentative approval for Dapagliflozin and Saxagliptin Tablets

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Glenmark  Pharmaceuticals  Inc.,  USA  (Glenmark)  has  been  granted tentativeapproval by the United States Food & Drug Administration (U.S. FDA) for Dapagliflozin and Saxagliptin Tablets, 10 mg/5 mg, the generic version of Qtern®1Tablets, 10 mg/5 mg, of AstraZeneca AB.

According to IQVIATM 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*.

QTERN is a prescription medicine that contains dapagliflozin and saxagliptin abd it is brand of Astrazeneca. QTERN is used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

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.

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