US FDA Nod for Glenmark's Manufacturing Facility in North Carolina

Glenmark Pharmaceuticals has announced that the US FDA has 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) Tablets.

“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,” said Mr. Robert Matsuk, President, North America & Global API at Glenmark Pharmaceuticals. “Additionally, we are pleased that the investment we’ve made in our site will continue to create new, high-quality jobs in the Monroe community, where we have a commitment to long-term growth and expansion.”

The Monroe, North Carolina facility is Glenmark’s first manufacturing site in the US, designed to manufacture a variety of fixed dose pharmaceutical formulations. Glenmark has invested more than $100-mn in the facility with plans for further expansion in coming years. At peak capacity, the site is anticipated to produce 300-400 mn tablets and capsules, 20-25 mn vials and pre- filled syringes and 25-30 mn ampoules for inhaled formulations.