Chloroprocaine

As an upgraded alternative to amide local anesthetics, chloroprocaine reversibly blocks sodium channels in nerve cell membranes and inhibits the generation and conduction of nerve impulses, achieving a rapid and reversible local anesthetic effect in short surgeries. Its metabolic pathway is independent of the liver, and it is mainly rapidly hydrolyzed by plasma pseudocholinesterase. The anesthetic onset time is only 6-12 minutes, and the duration of action is 30-60 minutes, with no accumulation risk after surgery. It is particularly suitable for epidural anesthesia, infiltration anesthesia, nerve block anesthesia, as well as the anesthesia needs of patients with hepatic insufficiency, elderly populations and outpatient day surgery. Its clinical safety is significantly better than that of traditional local anesthetics.

In 2022, the domestic local anesthetic market size had exceeded 7.5 billion yuan, among which the short-acting local anesthetic segment had a compound annual growth rate of 8.2%, higher than the growth rate of the overall local anesthetic market. With the clinical advantages of rapid onset and rapid metabolism, the market share of chloroprocaine has been increasing year by year. At present, nearly 10 domestic enterprises have obtained preparation approvals. Against the background of centralized procurement, the demand for API continues to expand. In 2023, the domestic consumption of chloroprocaine API increased by 17% year-on-year, and the competitive landscape is concentrated in the top 3 API manufacturers.

The original research enterprise of chloroprocaine is Hospira Inc., with the original brand name Nesacaine, and the core compound patent expired in 2001. The main dosage form of the original product is injection, including two specifications of 20ml:400mg and 30ml:600mg, which have been included in the FDA Orange Book Reference Listed Drug Catalog. At present, the chloroprocaine APIs of many domestic enterprises have been registered with CDE, among which there are more than 5 registration numbers in Status A. Chloroprocaine hydrochloride injection and chloroprocaine hydrochloride powder for injection have both been approved for domestic marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for chloroprocaine API, and most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the full-process needs of API enterprises in quality research, impurity control, registration and declaration, etc.