Unichem Labs gets ANDA approval for schizophrenia medicine

Unichem Labs gets ANDA approval for schizophrenia medicine

By: IPP Bureau

Last updated : December 03, 2021 7:02 am



The product will be commercialized from Unichem's Ghaziabad plant


Unichem Laboratories has announced that it has received ANDA approval for its Aripiprazole tablets USP, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Abilify Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Otsuka Pharmaceutical Company, Ltd.

Aripiraprazole tablets are indicated for Schizophrenia and Irritability associated with Autistic Disorder. The product will be commercialized from Unichem's Ghaziabad Plant.

Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world. In India, The company is known for its product development, process chemistry and manufacturing complex API as well as dosage forms.

Unichem Laboratories ANDA USFDA

First Published : December 03, 2021 12:00 am