New Delhi: Glenmark Pharmaceuticals said the US health regulator has approved the first product from its Monroe, North Carolina based manufacturing facility.
The US Food and Drug Administration (USFDA) has provided its first supplemental Abbreviated New Drug Application(ANDA) approval for the company’s plant in Monroe, Glenmark said in a statement.
The approval covers Atovaquone and Proguanil Hydrochloride tablets, a generic version of GlaxoSmithKline’s Malarone tablets, it added.
“This approval is an important milestone for our US business, as the Monroe, NC site will expand our portfolio by providing the manufacturing foundation for future product approvals,” Glenmark Pharmaceuticals President, North America and Global API, Robert Matsuk said.
The Monroe facility is Glenmark’s first manufacturing site in the US, designed to manufacture a variety of fixed dose pharmaceutical formulations.
The Mumbai-based drug major has invested more than USD 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.
Glenmark has 16 manufacturing facilities in Europe, India and the US.