Glenmark gets USFDA approval for Dimethyl Fumarate Delayed-Release Capsules
Mumbai: Glenmark Pharmaceuticals Inc., USA today announced that the company has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg.
The product is a generic version of Tecfidera Delayed-Release Capsules, 120 mg and 240 mg, of Biogen, Inc.
According to IQVIATM sales data for the 12 month period ending August, the Tecfidera Delayed-Release Capsules, 120 mg and 240 mg market achieved annual sales of approximately $3.8 billion*.
Glenmark's current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 46 ANDA's pending approval with the U.S. 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, " the release stated
Glenmark Pharmaceuticals Ltd. (GPL) is a global pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.