Zydus Cadila’s arm gets tentative approval from USFDA for Pimavanserin Capsules

31 Dec 2021 Evaluate

Zydus Cadila’s U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the USFDA to market Pimavanserin Capsules in the strength of 34 mg (USRLD: Nuplazid Capsules). Pimavanserin is an atypical antipsychotic and is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

The drug will be manufactured at the group’s formulation manufacturing facility at 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.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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