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

Written By : Susmita Roy |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-14T16:00:31+05:30 | Updated On 20 March 2024 3:08 PM IST

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

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.

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.

Read also: Zydus Healthcare gets CDSCO Panel Nod To study FDC Empagliflozin plus Metoprolol Succinate

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).

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.

zydus lifescienceszydus lifesciences newsUSFDAchlorpromazine hydrochloride injectionmood disordershiccupstetanus

Susmita Roy

Mpharm (Pharmacology)

Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751