FDA approves sANDA for Glenmark Pharmaceuticals' Monroe facility - CDR

PARAMUS, N.J. — 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, N.C. 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 U.S. business, as the Monroe, N.C. site will expand our portfolio by providing the manufacturing foundation for future product approvals,” said 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, N.C. facility is Glenmark’s first manufacturing site in the U.S., designed to manufacture a variety of fixed dose pharmaceutical formulations. Glenmark has invested more than $100 million into the facility with plans for further expansion in the coming years. At peak capacity, the site is anticipated to produce 300-400 million tablets and capsules, 20-25 million vials and pre-filled syringes and 25-30 million ampoules for inhaled formulations. Globally, Glenmark has 16 manufacturing facilities in Europe, India and the U.S., operating under Good Manufacturing Practices to ensure quality and safety.