Sevoflurane

The safety and controllability of inhalation anesthesia have always been the core focus of perioperative management in surgical procedures. As a new generation of halogenated inhalation anesthetics, sevoflurane has become the mainstream choice for clinical anesthesia with its unique advantages of low blood-gas partition coefficient, rapid induction and recovery, and low airway irritation. Its mechanism of action is to regulate the activity of γ-aminobutyric acid A receptors and N-methyl-D-aspartic acid receptors in the central nervous system and inhibit nerve signal transmission, which can meet the needs of induction and maintenance of general anesthesia for adults and children of all age groups. It is especially suitable for anesthesia in outpatient surgery, pediatric surgery and elderly patients, with mild impact on the circulatory system and low incidence of postoperative nausea and vomiting, and its clinical recognition continues to improve.

The global sevoflurane market size has stabilized at more than USD 1.2 billion in recent years, and the annual growth rate of the Chinese market has remained at around 6%. It is the variety with the highest proportion in the inhalation anesthetic segment, accounting for nearly 40%. The competitive landscape shows a parallel trend of original research drugs and generic drugs. Domestic generic drug enterprises have gradually realized import substitution by virtue of cost advantages. At present, more than 15 enterprises have obtained the approval documents for sevoflurane preparations. In addition to the original research manufacturers, more than 5 domestic enterprises have large-scale production capacity in the API supply side. After the implementation of volume-based procurement, the terminal price has dropped by more than 50%, and the accessibility of primary medical institutions has been greatly improved.

The original research enterprise of sevoflurane is Maruishi Pharmaceutical Co., Ltd. of Japan, and the original research trade name is "Sevofrane". Its core compound patent was first applied for in 1975, and the patents in major global markets expired successively in the 1990s. The main dosage form approved by the original research is inhalation solution, with specifications of 100ml and 250ml, which has been included in the Chinese *Catalogue of Chemical Reference Preparations* and the FDA Reference Preparation Catalogue. At present, more than 10 domestic enterprises have completed the CDE registration of sevoflurane API, most of which are in status A and can be used for associated review. More than 20 approval documents for the corresponding sevoflurane for inhalation preparations have been approved for marketing. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for sevoflurane API, and most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of the whole process of API R&D, quality research and declaration.