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Glenmark gets ANDA approval for dimethyl fumarate delayed-release capsules

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MUMBAI, India — Glenmark Pharmaceuticals 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 generic version of Tecfidera1 Delayed-Release Capsules, 120 mg and 240 mg, of Biogen.

According to IQVIATM sales data for the 12 month period ending August, the Tecfidera Delayed-Release Capsules, 120 mg and 240 mg market2 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.


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