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 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 Ahmedabad, India, March 14, 2024 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 US P, 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, seve re 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 Jan- 24). The group now has 3 91 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04. (*as of 31st December 2023) ###

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