USFDA nod to Zydus Cadila’s Generic Schizophrenia Drug

Zydus Cadila, a pharmaceutical company, said on Friday that it has acquired clearance from the US Food and Drug Administration to manufacture generic Cariprazine pills, which are used to treat schizophrenia.
The US Food and Drug Administration (USFDA) has given provisional clearance to the company’s subsidiary for Cariprazine capsules in the strengths of 1.5 mg, 3 mg, 4.5 mg, and 6 mg, according to the drug firm.

Cariprazine is an atypical antipsychotic medication used for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder.

The drug production will be done at the group’s formulation manufacturing facility in the Special Economic Zone (SEZ), Ahmedabad.

The group now has 325 approvals and has so far filed over 400 ANDAs (Abbreviated New Drug Applications) since the commencement of the filing process in FY 2003-04, the drug maker noted.