Glenmark Pharmaceuticals’ arm gets USFDA’s nod for Fingolimod Capsules

20 Mar 2017 Evaluate

Glenmark Pharmaceuticals’ arm - Glenmark Pharmaceuticals Inc., USA, has received tentative approval by the United States Food & Drug Administration (USFDA) 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 around $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 USFDA. 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.

Glenmark Pharmaceuticals is a global innovative pharmaceutical company with operations in more than 80 countries. It has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of oncology, respiratory disease, and dermatology.


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