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Glenmark gets ANDA approval for Dimethyl Fumarate
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Glenmark gets ANDA approval for Dimethyl Fumarate

Agency News

Mumbai, Oct 9 : Pharma major Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, a generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc.

According to IQVIATM sales data for the 12 month period ending August 2019, the Tecfidera Capsules, 120 mg and 240 mg market2 achieved annual sales of approximately USD3.7 billion, the company said in a filing with BSE.

Glenmark's current portfolio consists of 161 products authorized for distribution in the U.S. marketplace and 49 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. (UNI)