Glenmark Pharma rose over 3.5% today to hit an intra day high at Rs.603.35 and continues to remain firmly in the green.
The company today announced that the U.S. Food & Drug Administration provided its first supplemental Abbreviated New Drug Application (sANDA) approval for the company’s 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.
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. Glenmark 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. Globally, Glenmark has 16 manufacturing facilities in Europe, India and the U.S., operating under Good Manufacturing Practices (GMP) to ensure quality and safety.