Unichem Labs bags USFDA nod for chronic angina drug Ranolazine Extended Release

Mumbai: Unichem Laboratories Limited has announced that the company has received ANDA approval for its Ranolazine Extended-Release Tablets, 500 mg and 1000 mg from the United States Food and Drug Administration (USFDA).

The product is a generic version of Ranexa (ranolazine extended-release tablets) 500 mg and 1000 mg, of Gilead Sciences Inc.

Ranolazine Extended-Release Tablets, 500 mg, and 1000 mg are indicated for the treatment of chronic angina. Chronic angina is a prevalent manifestation of cardiovascular disease. It is most commonly due to insufficient oxygen supply from fixed epicardial lesions in the coronary arteries.

The product will be commercialized from Unichem’s Goa Plant.

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Headquartered in Mumbai, Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. The company was founded in 1944 by Padmabhushan Late Mr. Amrut V Mody. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world. 

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