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Glenmark Pharmaceuticals’ arm gets USFDA’s nod for Dimethyl Fumarate Delayed-Release Capsules

07 Oct 2020 Evaluate

Glenmark Pharmaceuticals’ subsidiary -- Glenmark Pharmaceuticals Inc., USA, has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, the generic version of Tecfidera Delayed-Release Capsules, 120 mg and 240 mg, of Biogen, Inc. Sales data for the 12 month period ending August, the Tecfidera Delayed-Release Capsules, 120 mg and 240 mg market achieved annual sales of approximately $3.8 billion.

Glenmark’s current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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