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Glenmark gets USFDA’s tentative approval for Dimethyl Fumarate Delayed-Release Capsules

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) 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 IQVIA sales data for the 12 month period ending August 2019, the Tecfidera Capsules, 120 mg and 240 mg market achieved annual sales of approximately $3.7 billion. Glenmark’s current portfolio consists of 161 products authorized for distribution in the US marketplace and 49 ANDA’s pending approval with the USFDA.

Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).

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