Glenmark Pharmaceuticals receives tentative ANDA approval for Fingolimod Capsules, 0.5 mg
MUMBAI, India, March 20, 2017 – Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya® Capsules of Novartis Pharmaceuticals Corp.
According to IMS Health sales data for the 12 month period ending January 2017, Gilenya® Capsules, 0.5 mg achieved annual sales of approximately $2.03 billion*.
Glenmark’s current portfolio consists of 112 products authorized for distribution in the U.S. marketplace and approximately 65 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.
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1Market includes brand and all available therapeutic equivalents
*IMS Health National Sales Perspectives: Retail & Non-Retail, January 2017
About Glenmark Pharmaceuticals Ltd:
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2016). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation [asthma/COPD, rheumatoid arthritis etc.] and Pain [neuropathic pain and inflammatory pain]. The company has a significant presence in the branded generics markets across emerging economies including India. GPL along with its subsidiaries operate 17 manufacturing facilities across four countries and has five R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries including the US, EU, South America and India.
For further information, please contact:
Ramkumar Uppara/Shibani Shah
Glenmark, Mumbai, India
Tel: [+91 22] 4018 9984/9348