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Glenmark gets final approval from USFDA for Azelaic Acid Gel

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Azelaic Acid Gel, 15%, a generic version of Finacea Gel, 15%, of Leo Pharma A/S. According to IQVIA sales data for the 12 month period ending September 2018, the Finacea Gel, 15% market achieved annual sales of approximately $64.1 million.

The company’s current portfolio consists of 143 products authorized for distribution in the US marketplace and 56 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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