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First sANDA (Supplemental Abbreviated New Drug Application) approved by USFDA for Glenmark Pharmaceuticals Manufacturing Facility In Monroe, North Carolina

Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with presence in more than 50 countries and has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology.

The Monroe, North Carolina facility is Glenmark's first manufacturing site in the U.S., wherein Glenmark has invested more than $100 million into the facility and is designed to manufacture a variety of fixed dose pharmaceutical formulations such as 300-400 million tablets and capsules, 20-25 million vials and pre-filled syringes and 25-30 million ampoules for inhaled formulations. The U.S. Food & Drug Administration provided its first supplemental Abbreviated New Drug Application (sANDA) approval to this facility for 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.

According to Robert Matsuk, President, North America & Global API at Glenmark Pharmaceuticals, “the approval is significant from the point of view that Monroe, N.C. site will expand company’s portfolio by providing the manufacturing foundation for future product approvals and also the investment made in the site will continue to create new, high-quality jobs in the Monroe community, where the company has a commitment to long-term growth and expansion."