Zydus Cadila gets USFDA’s nod for Aripiprazole Tablets

08 Jan 2019 Evaluate

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Aripiprazole Tablets USP (US RLD - Abilify) in the strengths of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

Aripiprazole is an antipsychotic drug (atypical type). It is used to treat mental/mood disorders such as bipolar disorder, schizophrenia, Tourette's disorder, and irritability associated with autistic disorder. It is also used in combination with other medications to treat depression. It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters).

The group now has 243 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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