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Glenmark Pharmaceuticals gets sANDA approval for facility in Monroe, North California

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From USFDA

Glenmark Pharmaceuticals announced that the U.S. Food & Drug Administration provided its first supplemental Abbreviated New Drug Application (sANDA) approval for the company's manufacturing facility in Monroe, North Carolina. The 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) Tablets1.

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First Published: Jun 19 2018 | 8:51 AM IST

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