Tranexamic

As a classic representative of antifibrinolytic agents, tranexamic acid exerts a hemostatic effect by reversibly blocking the lysine binding sites on plasminogen and inhibiting plasmin-mediated fibrin degradation. It is widely used clinically for perioperative bleeding prevention in surgical procedures, treatment of postpartum hemorrhage, and control of hereditary angioedema attacks. It can also assist in alleviating pigmentation problems such as chloasma, and its applicable population covers patients in multiple departments including surgery, obstetrics and gynecology, and dermatology. It is a first-line hemostatic drug recommended by multiple clinical guidelines worldwide.At present, the global market size of tranexamic acid is stably above 1.2 billion US dollars, with a compound annual growth rate of approximately 3.8%, and the domestic market size is nearly 1.8 billion RMB. Due to its early launch time and mature preparation process, the competitive landscape of this variety is dominated by generic drugs. China is the world's largest producer and exporter of tranexamic acid API, with production capacity accounting for more than 70% of the total global supply. Domestic preparations have been included in the national centralized procurement, and the winning bid price has dropped by more than 80% compared with the previous level, which further drives the increase in clinical dosage, and the demand for upstream APIs continues to be stable.The original research enterprise of tranexamic acid is Daiichi Sankyo Co., Ltd. of Japan, with the original brand name "Transamin". Its core compound patent expired globally around 1980. The mainstream dosage forms of the original product include tablets (250mg, 500mg) and injections (10ml:1g), both of which have been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA reference preparation catalogue. In terms of the domestic market, more than 30 enterprises have completed the registration of tranexamic acid API with Class A status publicized on CDE at present, and the total number of domestic generic drug approvals for dosage forms such as tablets and injections exceeds 200, with sufficient clinical supply. (Data as of October 2024, please refer to the official CDE website for the latest information)CATO can provide a full range of tranexamic acid impurity reference standards. The products simultaneously meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most impurities are in stock, and spot orders placed before 16:00 can be shipped on the same day, which can fully meet the needs of API manufacturers in quality research, release testing and consistency evaluation.

目前全球氨甲环酸市场规模稳定在12亿美元以上，年复合增长率约3.8%，国内市场规模近18亿元人民币。由于上市时间早、制备工艺成熟，该品种竞争格局以仿制药为主，中国是全球最大的氨甲环酸原料药生产和出口国，产能占全球总供给的70%以上。国内制剂端已纳入国家集采，中标价格较前下降超80%，进一步带动临床用量提升，上游原料药需求持续稳定。

氨甲环酸原研企业为日本第一三共株式会社，原研商品名为“Transamin”，其核心化合物专利已在1980年前后全球范围到期。原研主流剂型包括片剂（250mg、500mg）与注射剂（10ml:1g），均已列入中国《化学药品参比制剂目录》及FDA参比制剂目录。国内方面，目前已有超30家企业的氨甲环酸原料药在CDE完成登记获得A状态公示，片剂、注射剂等剂型的国产仿制药批文合计超过200个，临床供给充足。（数据截至2024年10月，最新请以CDE官网为准）

CATO/佳途科技可提供氨甲环酸全系列杂质标准品，产品同时符合中国药典、FDA等多法规体系合规要求，大部分杂质均备有现货，16:00前完成下单的现货订单当日即可发出，可充分满足原料药生产企业的质量研究、放行检测及一致性评价相关需求。