FDA gives Indian drugmaker Glenmark its first approval for generics produced at U.S. plant

The FDA gave Indian generic drugmaker Glenmark its first supplemental Abbreviated New Drug Application approval for its U.S. facility. (Glenmark)

The FDA gave Indian generic drugmaker Glenmark its first supplemental Abbreviated New Drug Application approval for its manufacturing facility in Monroe, North Carolina, the company said.

The regulatory agency’s approval is for the production of atovaquone and proguanil hydrochloride tablets, a generic version of GlaxoSmithKline's Malarone used to treat malaria.

"This approval is an important milestone for our U.S. business, as the Monroe, North Carolina, site will expand our portfolio by providing the manufacturing foundation for future product approvals," Robert Matsuk, Glenmark’s president for North America & Global API, said in a statement. "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."

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RELATED: Glenmark to build $100M plant in North America

Glenmark invested more than $100 million in the Monroe site, and has plans to expand the plant in the coming years. It is the company’s first plant in the U.S. and was designed to produce a variety of fixed dose pharmaceutical formulations. When operating at peak capacity, the plant is expected to produce 300-400 million tablets and capsules, 20-25 million vials and prefilled syringes and 25-30 million ampoules for inhaled formulations.

The company now has 16 manufacturing sites located in Europe, India and the U.S.


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