Nafamostat

In the fields of acute pancreatitis, disseminated intravascular coagulation (DIC) and anticoagulant therapy for blood purification, nafamostat is a classic clinical option with both broad-spectrum protease inhibitory effect and high safety. As a synthetic serine protease inhibitor, it can simultaneously inhibit the activities of various proteases such as thrombin, plasmin, trypsin and kallikrein. It can block the coagulation cascade to exert an anticoagulant effect, inhibit trypsin autodigestion to alleviate the progression of pancreatitis, and reduce the occurrence of coagulation events during hemodialysis and extracorporeal membrane oxygenation (ECMO). Its clinically applicable population covers patients with acute pancreatitis, patients with DIC, and critically ill patients who require extracorporeal circulation anticoagulation support.

At present, the global nafamostat market size maintains a steady growth. In 2023, the overall market size has exceeded USD 230 million, and the compound annual growth rate is maintained at around 4.7%. As one of the core application markets of nafamostat, China accounts for more than 35% of the global market share. At present, the domestic preparation market is dominated by generic drugs, and more than 10 enterprises have obtained preparation approvals. After the implementation of the centralized procurement policy, the price of preparations has dropped by more than 60%, and the cost control and supply stability of upstream API have become the core competitive elements for downstream enterprises.

The original developer of nafamostat is Torii Pharmaceutical Co., Ltd. of Japan, with the original brand name "Futhan". Its core compound patent expired globally in 2001. The main dosage form approved for the original drug is injection, with specifications of 10mg and 50mg. The original preparation has been included in the China Listed Drug Catalogue as a reference preparation. As of now, there are a total of 16 nafamostat API registration entries on the China CDE API Registration Platform, among which 11 are in the "A" status and can be marketed and sold in China, and more than 15 product specifications of supporting preparations have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the needs of nafamostat quality research and compliance declaration, CATO can provide a full set of impurity reference standards for this API. Most products support spot supply, and spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmacopoeias of various countries and regulatory authorities such as Chinese Pharmacopoeia and FDA, and can provide reliable reference standard support for API and preparation enterprises in quality research, stability investigation and registration declaration.