Zydus Lifesciences Receives USFDA Approval

Ahmedabad: Zydus Lifesciences Limited has announced that the Company 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, including:

• 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)
• 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 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.

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Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer-related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R & D.

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