Glenmark Pharmaceuticals receives ANDA approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg

MUMBAI, India, Oct. 7, 2020 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) 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 Tecfidera¹ Delayed-Release Capsules, 120 mg and 240 mg, of Biogen, Inc.

According to IQVIATM sales data for the 12 month period ending August, the Tecfidera Delayed-Release Capsules, 120 mg and 240 mg market² 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. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

About Glenmark Pharmaceuticals Ltd

Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). For more information, visit www.glenmarkpharma.com

^1. All brand names and trademarks are the property of their respective owners.
^2. Market includes brand and all available therapeutic equivalents
^*IQVIATM National Sales Perspectives: Retail & Non-Retail, August 2020

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