Zydus receives Final Approval from the USFDA for Chlorpromazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/2 mL (25 mg/mL), Single-Dose Vials

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Chlorpromazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/2 mL (25 mg/mL), Single-Dose Vials, (RLD: Thorazine Injection).

Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders (such as schizophrenia, psychotic disorders, manic phase of bipolar disorder, severe behavioral problems in children). It is also used to control nausea/vomiting, relieve prolonged hiccups, relieve restlessness/anxiety before surgery, treat a certain liver problem (porphyria), and help treat tetanus. The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara (India).

Chlorpromazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/2 mL (25 mg/mL), Single-Dose Vials, had annual sales of USD 12.5 mn. in the United States (IQVIA MAT Jan24). The group now has 391 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 968.70 as compared to the previous close of Rs. 987.50. The total number of shares traded during the day was 30456 in over 1926 trades.

The stock hit an intraday high of Rs. 996.60 and intraday low of 960.85. The net turnover during the day was Rs. 29613026.00.

(*as of 31st December 2023)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 USFDA FinalApproval ChlorpromazineHydrochloride Injection