Shares of Glenmark Pharma rose 3% as the company received the USFDA’s approval for its Monroe facility.
The US Food & Drug Administration (USFDA) provided its first supplemental abbreviated new drug application (sANDA) approval for the company’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.
Robert Matsuk, President, North America & Global API at Glenmark Pharmaceuticals said, “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.”
The Monroe, North Carolina facility is company’s first manufacturing site in the US, designed to manufacture a variety of fixed dose pharmaceutical formulations.
The company has invested more than USD 100 million into the facility with plans for further expansion in the coming years.