Glenmark Pharmaceuticals’ arm receives USFDA’s approval for Fingolimod Capsules

19 Jun 2020 Evaluate

Glenmark Pharmaceuticals’ subsidiary -- Glenmark Pharmaceuticals Inc., USA, 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 IQVIATM sales data for the 12 month period ending April 2020, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately $2.1 billion.

The company’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.

Glenmark Pharmaceuticals (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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