Etamsylate

In the clinical prevention and treatment of perioperative bleeding and various hemorrhagic diseases, the rational application of hemostatic drugs is the core link to reduce patients' risks. Etamsylate, a commonly used procoagulant hemostatic drug in clinical practice, can reduce capillary permeability, enhance platelet aggregation and adhesion, promote the release of coagulation active substances, and shorten coagulation time. It is widely used in the prevention and treatment of bleeding before and after surgery, and can also be used for bleeding caused by poor platelet function and increased vascular fragility, such as cerebral hemorrhage, gastrointestinal bleeding, urinary tract bleeding, fundus hemorrhage, gingival bleeding, epistaxis, etc. It is one of the basic drugs in hemostatic regimens of multiple departments including surgery, internal medicine, and otorhinolaryngology.At present, the overall domestic market size of hemostatic API exceeds 3 billion yuan, among which the procoagulant subcategory accounts for nearly 45%. As a mature hemostatic variety with rigid clinical demand, etamsylate has an annual market size of around 300 million yuan, with a compound annual growth rate of about 4% in the past three years, and the demand for downstream preparations is highly rigid. In terms of the competitive landscape, the concentration of domestic etamsylate API manufacturers is high, with the top 3 enterprises accounting for more than 85% of the market share. This variety has been included in the centralized procurement catalogs of multiple provinces, and enterprises with stable production capacity, compliant impurity control, and outstanding cost advantages have stronger competitiveness on the supply side.Etamsylate is an early marketed hemostatic drug with no clear original research enterprise. At present, there are more than 20 A-status registration numbers for domestically produced etamsylate API, and the approved preparations include injection, tablets, etamsylate for injection, etc. Among them, etamsylate injection is a variety in the National Essential Drug List and also a commonly selected reference preparation in clinical practice, and the preparation of this variety from multiple domestic enterprises has passed the consistency evaluation. (Data as of June 2025, please refer to the official website of CDE for the latest information)CATO provides a full set of impurity reference standards for etamsylate API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products are compliant with multiple regulations including the Chinese Pharmacopoeia and FDA, which can fully meet the demand for impurity reference standards in various stages such as API R&D, quality research, and consistency evaluation, and provide stable technical and product support for the construction of enterprises' quality control systems.

现阶段国内止血类原料药整体市场规模超过30亿元，其中促凝血亚类占比接近45%。酚磺乙胺作为临床刚需的成熟止血品种，年市场规模稳定在3亿元左右，近三年复合增长率维持在4%左右，下游制剂需求刚性较强。竞争格局方面，国内酚磺乙胺原料药生产企业集中度较高，头部3家企业占据超过85%的市场份额，目前该品种已被纳入多省集采目录，产能稳定、杂质控制达标、成本优势突出的企业在供应端具备更强竞争力。

酚磺乙胺为较早上市的止血药物，无明确原研企业，国内生产的酚磺乙胺原料药目前已有超过20条A状态登记号，获批制剂包括注射液、片剂及注射用酚磺乙胺等，其中酚磺乙胺注射液是国家基本药物目录品种，也是临床常用的参比制剂选择，国内多家企业的该品种制剂已通过一致性评价。（数据截至2025年6月，最新请以CDE官网为准）

CATO/佳途科技提供酚磺乙胺API全套杂质标准品，大部分产品现货供应、现货产品16:00前下单当天发货、中国药典/FDA多法规合规，可充分满足原料药研发、质量研究、一致性评价等各阶段的杂质对照品需求，为企业的质量控制体系搭建提供稳定的技术与产品支撑。