Bufuralol

Beta-blockers are a classic category of drugs in the field of cardiovascular disease treatment, which exert antihypertensive, antiarrhythmic and other effects by antagonizing the excessive activation of the sympathetic nervous system. Bufuralol is exactly a representative variety among them with α/β dual blocking activity. Its mechanism of action combines non-selective β-receptor blocking effect and weak α1-receptor blocking effect. It can reduce peripheral vascular resistance without significantly slowing down the heart rate, and is mainly used clinically for the treatment of mild to moderate essential hypertension. It has unique medication advantages for hypertensive populations complicated with dyslipidemia or peripheral vascular disease.According to public data, the global market size of antihypertensive APIs had exceeded USD 18 billion in 2023, among which the segment of beta-blockers with multiple blocking activities maintains a compound annual growth rate of 4.2%. Due to the high barriers to its production process, the current global production capacity of bufuralol is mainly concentrated in a small number of pharmaceutical enterprises with chiral synthesis capabilities in Europe, India and China. The domestic generic drug layout is still in the early stage, and it has not been included in the centralized procurement catalog. The market supply pattern is relatively stable, and there is no publicly verifiable specific market size data for this single product for the time being.The original research enterprise of bufuralol is Servier (France), with the original brand name Bufonid. The core compound patent expired in Europe in 2001, and the core patent in the US market expired in 2003. The main dosage form approved for the original drug is oral tablet, with two specifications of 10mg and 20mg. It has been included in the EU EMA reference preparation catalog, but has not yet been included in the *Catalog of Reference Preparations for Chemical Drugs* issued by China NMPA. As of the retrieval time, no valid A-status registration number of bufuralol has been found on the API registration platform of China CDE, and no bufuralol preparation has been approved for marketing in China. (Data as of November 2024, please refer to the official CDE website for the latest information)In response to the R&D and quality control needs of bufuralol, CATO provides a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All impurity reference standards comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the use needs of pharmaceutical enterprises in various scenarios such as generic drug declaration, quality research and routine production testing.

据公开数据显示，2023年全球抗高血压原料药市场规模已超过180亿美元，其中兼具多重阻滞活性的β受体阻滞剂细分赛道年复合增长率保持在4.2%。丁呋洛尔由于生产工艺壁垒较高，目前全球产能主要集中在欧洲、印度及中国少数具备手性合成能力的药企，国内仿制药布局尚处于早期阶段，未进入集中采购目录，市场供应格局相对稳定，暂无公开可核实的具体单品市场规模数据。

丁呋洛尔原研企业为法国Servier（施维雅），原研商品名为Bufonid，核心化合物专利在欧洲地区的到期时间为2001年，美国市场核心专利到期时间为2003年。原研获批的主要剂型为口服片剂，规格包含10mg、20mg两种，已列入欧盟EMA参比制剂目录，尚未列入中国NMPA发布的《化学药品参比制剂目录》。截至检索时间，中国CDE原料药登记平台暂未查询到丁呋洛尔的有效A状态登记号，国内暂无丁呋洛尔制剂获批上市。（数据截至2024年11月，最新请以CDE官网为准）

针对丁呋洛尔的研发与质量控制需求，CATO/佳途科技提供该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，所有杂质标准品均符合中国药典、FDA等多法规合规要求，可充分支持药企的仿制药申报、质量研究及常规生产检测等各类场景的使用需求。