Zydus receives USFDA final approval for chlorpromazine hydrochloride injection

Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders

Zydus Lifesciences Limited 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.