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By EquityPandit

Glenmark Pharma gets USFDA nod for Monroe facility

June 19, 2018

The US Food & Drug Administration (USFDA) has given its first supplemental abbreviated new drug applications (ANDA) approval, to the Glenmark Pharma’s manufacturing facility in Monroe, North Carolina.

The said approval covers, 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.

Moreover, Robert Matsuk, President, North America & Global API at Glenmark Pharmaceuticals stated, “This approval is an important milestone for our US business, as the Monroe, N.C. site will expand our portfolio by providing the manufacturing foundation for future product approvals.”

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