Glenmark Receives US FDA Tentative Approval for Fingolimod Capsules

The United States Food & Drug Administration (FDA) has granted tentative approval for Glenmark Pharmaceuticals' fingolimod capsules, 0.5 mg, the generic version of Gilenya capsules of Novartis Pharmaceuticals. 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 US marketplace and approximately 65 ANDA's pending approval with the US 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. All brand names and trademarks are the property of their respective owners. 1Market includes brand and all available therapeutic equivalents IMS Health National Sales Perspectives: Retail & Non-Retail, January 2017

Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. It is ranked among the top 80 pharma and biotec companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2016).