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Glenmark gets tentative USFDA nod for anti-coagulant drug

Press Trust of India  |  New Delhi 

Glenmark Pharmaceuticals has received tentative nod from the US health regulator for anti-coagulant medication Dabigatran Etexilate capsules.

"Glenmark Pharmaceuticals Inc, 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 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.

The company's current portfolio consists of 114 products authorised for distribution in the US marketplace and 65 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.

of the company were trading up 0.33 per cent at Rs 895.20 on

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, April 19 2017. 11:42 IST
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