Glenmark Gets FDA OK for First Generic at New NC Mfg Site

Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, has received approval of its first abbreviated new drug application by the US Food & Drug Administration (FDA) made at the company’s new manufacturing facility in Monroe, North Carolina.

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, for treating malaria.

The Monroe, North Carolina facility is Glenmark’s first manufacturing site in the US and is designed to manufacture a variety of fixed-dose pharmaceutical formulations. Glenmark invested more than $100 million into the facility and has plans for further expansion in the coming years, according to the company. At peak capacity, the company says the site is anticipated to produce 300 million to 400 million tablets and capsules, 20 million to 25 million vials and prefilled syringes and 25 million to 30 million ampuls for inhaled formulations. Globally, Glenmark has 16 manufacturing facilities in Europe, India and the US, which operate under GMP.

Source: Glenmark Pharmaceuticals

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