Glenmark Pharma gets ANDA tentative approval for Dabigatran Etexilate Capsules

expresspharmaDecember 22, 2020

Tag: Glenmark , Dabigatran Etexilate Capsules , ANDA , Pradaxa Capsules , FDA

Glenmark Pharmaceuticals has received tentative approval by the United States Food & Drug Administration (US FDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg, the generic version of Pradaxa Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim Pharmaceuticals.

According to IQVIA sales data for the 12 month period ending October 2020, the Pradaxa Capsules, 75 mg, 110 mg, and 150 mg market achieved annual sales of approximately $550.9 million.

Glenmark’s current portfolio consists of 166 products authorised for distribution in the US marketplace and 45 ANDA’s pending approval with the US FDA.