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USFDA approves ANDA for Glenmark Pharma’s manufacturing facility in Monroe

19 Jun 2018 Evaluate

US Food & Drug Administration (USFDA) has approved Glenmark Pharmaceuticals’ first supplemental Abbreviated New Drug Application (ANDA) of its manufacturing facility in Monroe, North Carolina. The approval is for Atovaquone and Proguanil Hydrochloride Tablets, 250 MG/100 MG and 62.5 MG/25 MG, a generic version of GlaxoSmithKline’s Malarone (atovaquone and proguanil hydrochloride) Tablets.

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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