Pharmaceutical company Glenmark Pharmaceuticals reported on Monday the receipt of approval from the US Food & Drug Administration for its first supplemental Abbreviated New Drug Application (sANDA) for its manufacturing facility in Monroe, North Carolina.

The company added the US FDA approval covers Atovaquone and Proguanil Hydrochloride Tablets in 250 MG/100 MG and 62.5 MG/25 MG, which is the generic version of GlaxoSmithKline's Malarone (atovaquone and proguanil hydrochloride) Tablets1.

In the US, the Monroe facility is its first manufacturing site that is designed to manufacture a variety of fixed dose pharmaceutical formulations. It has invested more than USD100m into the facility, with plans for further expansion in the coming years, according to the company.

At peak capacity, the the Monroe facility is expected to produce 300-400m tablets and capsules in 20-25m vials and pre-filled syringes as well as 25-30m ampoules for inhaled formulations, stated the company.

Additionally, the company has 16 manufacturing facilities in Europe, India and the US operating under Good Manufacturing Practices (GMP) to ensure quality and safety.