Glenmark Pharma gets UDFDA nod for first generic out of US facility

Glenmark Pharmaceuticals received a boost for its plans to manufacture drugs within the US, with the FDA approving the first generic manufacturing application from the facility.

The FDA approved the manufacturing of Atovaquone and Proguanil Hydrochloride Tablets at its Monroe, North Carolina facility via a supplementary ANDA (drug application).

“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.

The Monroe, North Carolina facility is Glenmark’s first manufacturing site in the U.S., designed to manufacture a variety of fixed dose pharmaceutical formulations.

The pharma company 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 prefilled syringes and 25-30 million ampoules for inhaled formulations, it added.

Glenmark has 16 manufacturing facilities in Europe, India and the U.S., operating under Good Manufacturing Practices.

Glenmark Pharmaceuticals is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drugand active pharmaceutical ingredient manufacturer; he named the company after his two sons.