Zydus Cadila's U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the USFDA to market Cariprazine Capsules in the strengths of 1.5 mg, 3 mg and 4.5 mg, and 6 mg (US RLD: VRAYLAR ). Cariprazine is an atypical antipsychotic.
Zydus' Cariprazine Capsules are indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
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