Glenmark Pharma gets final approval from USFDA for Atovaquone Oral Suspension

22 Nov 2018 Evaluate

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Atovaquone Oral Suspension USP, 750 mg/5 mL, a generic version of Mepron Oral Suspension, 750 mg/5 mL, of GlaxoSmithKline LLC. According to IQVIA sales data, the Mepron Oral Suspension, 750 mg/5 mL market2 achieved annual sales of around $119.1 million.

Glenmark’s current portfolio consists of 144 products authorized for distribution in the US marketplace and 55 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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