Ondansetron

Chemotherapy-, radiotherapy- and surgery-induced nausea and vomiting are common clinically relevant treatment-related adverse reactions, which can lead to electrolyte disorders and decreased treatment compliance in patients in severe cases. The advent of 5-hydroxytryptamine 3 (5-HT3) receptor antagonists has greatly improved this clinical dilemma. As the first marketed highly selective 5-HT3 receptor antagonist, ondansetron blocks 5-HT3 receptors in the peripheral and central nervous systems to inhibit the signal transduction of the vomiting reflex, and is a basic drug for current antiemetic therapy. It is indicated for nausea and vomiting caused by cytotoxic drug chemotherapy and radiotherapy in adult and pediatric patients, and can also be used for the prevention and treatment of postoperative nausea and vomiting.

As a core antiemetic variety with rigid clinical demand, the global market size of ondansetron is stable at around USD 1.6 billion, and the annual sales volume at the terminal of Chinese public medical institutions exceeds RMB 2 billion. In recent years, with the growth of the volume of day surgery, the demand has maintained a steady annual increase of around 5%. At present, the domestic preparation market has formed a pattern where the original research drug and generic drugs coexist. Generic drugs from more than 30 enterprises have passed the consistency evaluation, and multiple dosage forms have been included in the scope of national centralized procurement, with the price of winning bids dropping by more than 80%. The expansion of downstream preparation production capacity has directly driven the continuous release of demand for active pharmaceutical ingredients (APIs).

The original research enterprise of ondansetron is GlaxoSmithKline, with the original brand name "Zofran". Its core compound patent expired in the United States in 2006, and the Chinese patent has also expired and become invalid. The main dosage forms of the original research marketed products include tablets, injections and orally disintegrating tablets, with common specifications of 4mg and 8mg. The original research preparations have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. Up to now, there are more than 40 registration records of ondansetron APIs on the API registration platform of China's Center for Drug Evaluation (CDE), most of which are in status A and can be used for associated review. Multiple dosage forms of ondansetron preparations have been approved for marketing in China. (Data is as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for ondansetron API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use requirements in the processes of API R&D, quality research and registration declaration.