Unichem Lab gets USFDA nod for Aripiprazole tablets

The pharma company announce that it has received US drug regulator's approval for Aripiprazole tablets.

Unichem Laboratories has received abbreviated new drug application (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).

The product is a generic version of Abilify tablets of Otsuka Pharmaceutical Company.

Aripiraprazole tablets are indicated for schizophrenia and irritability associated with autistic disorder. The product will be commercialized from the company's Ghaziabad plant.

Unichem Laboratories reported a consolidated net loss of Rs 12.82 crore in Q2 FY22 as compared to a net profit of Rs 8.74 crore in Q2 FY21. Net sales during the quarter decreased 8.5% Y-o-Y (year-on-year) to Rs 290.66 crore.

Unichem Lab 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.

Shares of Unichem Laboratories jumped 5.96% to close at Rs 223.25 on BSE yesterday, 2 December 2021.

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