Aurobindo Pharma said Friday the company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Aripiprazole tablets, 2mg, 5mg, 10mg, 15mg, 20mg and 30mg (ANDA 203908). The product is ready for launch, it said.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Abilify tablets 2mg, 5mg, 10mg, 15mg, 20mg and 30mg of Otsuka Pharmaceutical Company, (Otsuka), the company.

Aripiprazole tablets are atypical antipsychotic indicated in the treatment symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). The approved product has an estimated market size of USD 7.3 billion for the twelve months ending August 2015 according to IMS.

Further the company said, "This is the 48th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 215 ANDA approvals (187 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA."

Shares of the company gained Rs 14.45, or 1.93%, to trade at Rs 765.00. The total volume of shares traded was 48,162 at the BSE (10.09 a.m., Friday).