Glenmark Pharma receives ANDA approval for Fingolimod Capsules, 0.5 mg
Mumbai/UNI: Glenmark Pharmaceuticals Inc, USA 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 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 dollars, a company statement said on Friday.
Glenmark’s current portfolio consists of 164 products authorized for distribution in the US marketplace and 44 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.
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