Zydus Lifesciences gains FDA aproval for Chlorpromazine Hydrochloride Injection

In a notable development for the pharmaceutical industry, Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has received final approval from the United States Food and Drug Administration (USFDA) for the manufacture and market of Chlorpromazine Hydrochloride Injection USP. The approval encompasses two formulations: 25 mg/mL and 50 mg/2 mL (25 mg/mL) in Single-Dose Vials, with Thorazine Injection serving as the reference listed drug (RLD). This medication is primarily used to treat a variety of mental and mood disorders, including schizophrenia, psychotic disorders, the manic phase of bipolar disorder, and severe behavioral problems in children. Additionally, it serves to control nausea and vomiting, relieve prolonged hiccups, alleviate restlessness and anxiety before surgery, treat certain liver problems (porphyria), and assist in the treatment of tetanus.

The approved drug will be produced at Zydus’s injectable manufacturing facility located in Jarod, near Vadodara, India. This facility is pivotal in the group’s efforts to supply high-quality medications across the globe. The Chlorpromazine Hydrochloride Injection has reported annual sales of USD 12.5 million in the United States, according to IQVIA MAT January 2024 data. This approval further expands Zydus Lifesciences Limited’s robust portfolio, which now boasts 391 approvals and includes over 460 Abbreviated New Drug Applications (ANDAs) filed since FY 2003-04.

This USFDA approval marks a significant achievement for Zydus Lifesciences Limited, highlighting its commitment to providing effective and essential medications for mental health conditions. It also underscores the company’s capability in adhering to the stringent regulatory standards of the USFDA, reinforcing its position as a leading player in the global pharmaceutical industry.

The USFDA’s approval of Zydus Lifesciences Limited’s Chlorpromazine Hydrochloride Injection signifies a crucial advancement in the treatment options available for severe mental and mood disorders. This approval not only reflects the company’s dedication to meeting the high-quality standards required for such critical medications but also its ongoing commitment to addressing the complex needs of patients suffering from mental health issues. By manufacturing the drug at its state-of-the-art facility in India, Zydus demonstrates its role in the global healthcare ecosystem, ensuring that patients in the United States and beyond have access to essential treatments. This development is a testament to the importance of innovation and regulation working hand in hand to improve patient care in the mental health sector.