Zydus gets USFDA’s final approval for Chlorpromazine Hydrochloride Injection, Single-Dose Vials

14 Mar 2024 Evaluate

Zydus Lifesciences 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 $12.5 million 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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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