"Glenmark Pharmaceuticals Inc, USA has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg and 150 mg," Glenmark Pharmaceuticals said in a BSE filing.
The product is the generic version of Pradaxa capsules, 75 mg, 110 mg and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc., it added.
According to IMS Health sales data for the 12 months to February 2017, the approved product has achieved annual sales of around USD 913 million, Glenmark said.
Shares of the company were trading up 0.33 per cent at Rs 895.20 on BSE.
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