Unichem Labs gets USFDA nod for Aripiprazole Tablets

Mumbai: Unichem Laboratories Limited has recently announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its schizophrenia pill Aripiprazole Tablets.

Aripiraprazole tablets are indicated for schizophrenia and irritability associated with autistic disorders.

"Unichem Laboratories 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 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," the company said in a statement.

The product will be commercialised 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.