Glenmark gets USFDA nod for generic Pradaxa capsules

Pradaxa capsules 75 mg, 110 mg, and 150 mg

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Medicine Capsule
Picture: Pixabay

Last Updated on December 23, 2020 by The Health Master

Glenmark Pharmaceuticals Ltd has received tentative approval by the United States Food & Drug Administration (USFDA) 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, Inc.

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 US$ 550.9 million.

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

In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.


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