Zydus receives Final Approvals from the USFDA for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") has received final approvals from the United States Food and Drug Administration (USFDA) to manufacture and market Pimavanserin Capsules, 34 mg (USRLD: Nuplazid® Capsules) and Pimavanserin Tablets, 10 mg (USRLD: Nuplazid® Tablets), respectively.

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis. Both the tablets and the capsules will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.

Pimavanserin Capsules, 34 mg had annual sales of USD 149 mn and Pimavanserin Tablets, 10 mg had annual sales of USD 10 mn in the United States (IQVIA Dec. Nov. 2023).

The group now has 384 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 709.40 as compared to the previous close of Rs. 706.20. The total number of shares traded during the day was 19962 in over 1237 trades.

The stock hit an intraday high of Rs. 710.95 and intraday low of 699.70. The net turnover during the day was Rs. 14082746.00.

(*as of 30th September 2023)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 USFDA FinalApprovals PImavanserinCapsules