Unichem receives ANDA approval for Prasugrel Tablets

Unichem receives ANDA approval for Prasugrel Tablets

By: IPP Bureau

Last updated : August 31, 2023 8:01 am



Prasugrel tablets are indicated to reduce the rate of thrombotic CV events


Unichem Laboratories Limited has received ANDA approval for its Prasugrel Tablets USP, 5 mg and 10 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Effient® (Prasugrel) Tablets, 5 mg and 10 mg, of Cosette Pharmaceuticals, Inc.

Prasugrel tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome. The product will be commercialized from Unichem's Goa Plant.

Unichem Laboratories Limited ANDA

First Published : August 31, 2023 12:00 am