Glenmark Pharma’s arm gets USFDA’s tentative nod for Dapagliflozin, Saxagliptin Tablets

29 Apr 2020 Evaluate

Glenmark Pharmaceuticals’ subsidiary -- Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) 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 market 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 USFDA. 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 is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).

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