MUMBAI / RAJKOT - In a regulatory update as submitted to the Indian Stock Exchanges, Mumbai headquartered pharmaceutical products manufacturing company Glenmark Pharmaceuticals Ltd said of having got a final nod from USFDA to sell medicine to treat cough and cold.
In a press-release titled, "Glenmark Pharmaceuticals receives ANDA approval for Fingolimod Capsules, 0.5 mg" as attached and enclosed with the regulatory filing as submitted by the company to the Indian Bourses, it further read that, Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya®1 Capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation.
According to IQVIA™ 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*.
Glenmark’s current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 44 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.
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