Granisetron

Chemotherapy-induced nausea and vomiting is one of the most common adverse reactions during tumor treatment, which severely affects patients' treatment compliance and quality of life. The advent of 5-hydroxytryptamine 3 (5-HT3) receptor antagonists has greatly reduced the incidence of such adverse reactions. As a second-generation highly selective 5-HT3 receptor antagonist, granisetron blocks 5-HT3 receptors in the peripheral and central nervous systems, inhibits the release of 5-HT from enterochromaffin cells in the small intestine induced by chemotherapeutic drugs or radiotherapy, and then blocks the conduction pathway of the vomiting reflex. It is clinically mainly used for the prevention and treatment of nausea and vomiting caused by tumor radiotherapy and chemotherapy as well as surgery, and is applicable to adults and pediatric patients over 2 years old. Compared with the first-generation products of the same category, it has stronger antiemetic effect, milder adverse reactions, and no additional side effects such as extrapyramidal reactions.

The global market size of antiemetics has exceeded 3 billion US dollars, among which 5-HT3 receptor antagonists account for nearly 40%. Granisetron, with clear clinical positioning and outstanding cost-effectiveness, has an increasing year-on-year share in primary medical and postoperative antiemetic scenarios. In terms of the domestic market, the overall market size of granisetron is approximately 800 million yuan, and the compound annual growth rate in the recent 3 years has remained at around 5%. It has now been included in the national centralized procurement catalog. After the centralized procurement, generic drugs account for more than 90% of the market, domestic enterprises have become the main force of market supply by virtue of cost advantages, and the market share of the original research product is less than 5%.

The original research enterprise of granisetron is Roche Pharmaceuticals of Switzerland, and the original brand name is "Kytril/康泉". The core compound patent expired in the United States in 1998, and the Chinese compound patent expired in 1999. The dosage forms approved for the original research product include tablets, injections and transdermal patches, and the common specifications are 1 mg for tablets and 3 ml:3 mg for injections. The original research injection has been included in the Reference Listed Drug Catalog of Chemical Medicines of China NMPA, and is also included in the FDA Reference Listed Drug Catalog. In terms of domestic API registration, as of now, more than 20 enterprises have obtained CDE registration numbers (status A) for granisetron APIs, and more than 30 enterprises have obtained marketing approval for granisetron oral and injection preparations. (Data 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 granisetron API, covering all categories such as synthesis process impurities, degradation impurities and enantiomers. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in API R&D, quality research, routine production inspection and other aspects.