Aminocaproic Acid

For hemorrhagic diseases caused by excessive activation of the fibrinolytic system, antifibrinolytic drugs are the core component of clinical hemostasis regimens. As the first-generation antifibrinolytic drug, aminocaproic acid competitively inhibits the binding of plasminogen to fibrin, blocks the activation pathway of plasminogen, and reduces fibrin degradation to exert a hemostatic effect. Clinically, it is mainly used to prevent and treat various hemorrhages caused by hyperfibrinolysis, including surgical trauma bleeding, obstetrics and gynecology bleeding, upper gastrointestinal bleeding due to liver cirrhosis, and adjuvant bleeding control for hemophilia patients. It is a commonly used basic drug for perioperative hemostasis and management of hemorrhagic diseases.

Aminocaproic acid was launched at an early stage, and the global market has now entered a mature and stable stage. In 2023, the global aminocaproic acid market size was approximately USD 120 million, and the domestic market size was approximately RMB 180 million, with a compound annual growth rate maintained at 2% to 3%. The market supply is dominated by generic drugs, with a fragmented competitive landscape. More than 20 domestic enterprises have obtained preparation production approvals. The domestic supply accounts for more than 90% of the API sector. It is a winning品种 in centralized procurement, with high clinical accessibility.

The original research enterprise of aminocaproic acid is Pfizer, and the original brand name is Amicar. The core compound patent expired globally around 1970. At present, the main dosage forms of the original research product on the market are tablets and injections. The tablet specification is 500mg, and the injection specifications are 250ml:5g and 10ml:1g. The original research product has been included in the FDA Reference Listed Drug Catalog, and the original research preparation has not been imported into China yet. In terms of domestic API registration, 11 enterprises have obtained Class A status for their aminocaproic acid APIs through CDE registration, and the corresponding approved preparation varieties cover two categories: aminocaproic acid injection and aminocaproic acid tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for aminocaproic acid, covering a full series of research reference materials including synthesis process impurities and degradation impurities. Most products are available in stock, and orders placed before 16:00 on the same day can be shipped on the same day. All products meet the regulatory requirements of multiple regions such as the Chinese Pharmacopoeia and FDA, and can fully meet the R&D needs of pharmaceutical enterprises in different scenarios such as API quality research and consistency evaluation.