Glenmark’s arm gets USFDA’s approval for Dapagliflozin Tablets

23 Mar 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 Tablets, 5 mg and 10 mg, the generic version of Farxiga 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 market 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 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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