Unichem Laboratories has received Tentative Approval for 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) for a generic version of ABILIFY (Aripiprazole Tablets) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg of Otsuka Pharmaceutical Company.
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.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company.
