drugset / Press release

Glenmark Pharmaceuticals receives ANDA approval for Fingolimod Capsules, 0.5 mg

2020-06-19 · Glenmark Pharmaceuticals Ltd. India · original glenmarkpharma.com ↗

Press Release For Immediate Release Glenmark Pharmaceuticals receives ANDA approval for Fingolimod Capsules, 0.5 mg Mumbai, India; June 19, 2020: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya®1 Capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation. According to IQVIATM sales data for the 12 month period ending April 2020, the Gilenya® Capsules, 0.5 mg market2 achieved annual sales of approximately $2.1 billion*. Glenmark’s current portfolio consists of 164 products authorized for distributio n in the U.S. marketplace and 44 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. —End— 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 201 9). For more information, visit www.glenmarkpharma.com For more information: Glenmark Media Contact Madhurima Gupta Jain Glenmark Pharmaceuticals, Mumbai, India Tel: +91 22 4018 9606 Email: [email protected] 1All brand names and trademarks are the property of their respective owners. 2Market includes brand and all available therapeutic equivalents *IQVIATM National Sales Perspectives: Retail & Non-Retail, April 2020

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