Glenmark receives ANDA tentative approval for Dapagliflozin Tablets, 5 mg and 10 mg

Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (US FDA) 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 authorised for distribution in the US marketplace and 45 ANDA’s pending approval with the US 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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