Zydus Lifesciences wins USFDA nod for Chlorpromazine Hydrochloride Injection for certain mental disorders

The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara (India).

Written By :  Susmita Roy
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-03-14 10:30 GMT   |   Update On 2024-03-20 09:38 GMT
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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 (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.
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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.

Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA to manufacture and market Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 15 mg, and 20 mg (USRLD: Zyprexa Zydis Orally Disintegrating Tablets).

Read also: Zydus bags USFDA nod for Olanzapine Orally Disintegrating Tablets to treat certain mental conditions

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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