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Unichem Labs secures USFDA nod for Aripiprazole Tablets
Mumbai: Drugmaker, Unichem Laboratories Limited, has recently announced that the company has received tentative approval for Abbreviated New Drug Application (ANDA) of 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 (Aripiprazole Tablets) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg of Otsuka Pharmaceutical Co Ltd.
Aripiprazole Tablets are indicated for Schizophrenia, Irritability Associated with Autistic Disorder and treatment of Tourette's disorder.
"Product will be commercialized from Unichem's Ghaziabad Plant on receipt of full approval," the company stated.
Read also: Unichem Labs gets USFDA nod for Amitriptyline HCl Tablets
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.
Read also: Unichem Labs gets USFDA nod for hypertension drug Guanfacine
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751