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 USD 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 (Q,N,C,F)* continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
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Shares of the company declined Rs 11.4, or 1.29%, to trade at Rs 874.95. The total volume of shares traded was 12,617 at the BSE (10.38 a.m., Monday).