Bisacodyl

As a commonly used laxative in clinical practice, bisacodyl is a diphenylmethane-type stimulant laxative. It acts directly on the large intestinal mucosa, stimulates sensory nerve endings in the intestinal tract, promotes the contraction of smooth muscles in the intestinal wall, and meanwhile inhibits water absorption in the intestinal tract, softens feces and improves the efficiency of intestinal peristalsis. Its indications include acute and chronic constipation and habitual constipation. It can also be used for abdominal imaging examinations and preoperative bowel preparation. It is applicable to adults and children over 6 years old. Due to its precise action site and relatively mild onset of effect, it is one of the first-line drugs recommended by domestic and foreign constipation diagnosis and treatment guidelines.The global market size of bisacodyl preparations has exceeded USD 1.2 billion, with a compound annual growth rate of 4.2% in the past three years, among which household over-the-counter dosage forms account for more than 60%. In terms of the domestic market, as the prevalence rate of the constipation population has risen to 17.6%, the clinical demand for bisacodyl continues to expand. In 2023, the domestic terminal sales increased by 8.7% year-on-year. The current competitive landscape is dominated by generic drugs. Local enterprises, relying on their cost advantages, account for more than 80% of the domestic API supply share. In addition, a number of preparations have passed the consistency evaluation, and the winning bid price in the centralized procurement of public medical institutions has dropped by more than 65% compared with the original research drug, further improving the product accessibility.The original research enterprise of bisacodyl is Boehringer Ingelheim, and the original research brand name is Dulcolax. Its core compound patent expired globally in 1998. At present, the main dosage forms of the original research drug marketed globally include enteric-coated tablets, suppositories and enemas. The common specifications of enteric-coated tablets are 5mg and 10mg, and that of suppositories is 10mg. The original research enteric-coated tablets have been included in the FDA Reference Listed Drug Catalog, and are also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. Domestically, bisacodyl APIs from more than 30 enterprises have completed registration (Status A) at the CDE. The approved and marketed preparations cover multiple dosage forms such as enteric-coated tablets and suppositories, which can fully meet the demands of the clinical and OTC markets. (Data as of September 2024, please refer to the official CDE website for the latest information)CATO provides a full set of impurity reference standards for bisacodyl API, which can cover the whole-process quality control requirements from R&D to registration and declaration. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, which can effectively help R&D and production enterprises shorten the impurity research cycle and reduce the risk of registration and declaration.

全球比沙可啶制剂市场规模已突破12亿美元，近三年复合增长率维持在4.2%，其中家用非处方剂型占比超60%。国内市场方面，随着便秘人群患病率上升至17.6%，比沙可啶的临床需求持续扩容，2023年国内终端销售额同比增长8.7%。当前竞争格局以仿制药为主，本土企业凭借成本优势占据国内80%以上的原料药供应份额，且已有多款制剂通过一致性评价，在公立医疗机构集采中中标价格较原研下降超65%，进一步提升了产品可及性。

比沙可啶原研企业为勃林格殷格翰，原研商品名为Dulcolax（乐可舒），其核心化合物专利已于1998年全球到期。目前原研在全球上市的主要剂型包括肠溶片、栓剂、灌肠剂，肠溶片常见规格为5mg、10mg，栓剂为10mg。原研肠溶片已被列入FDA参比制剂目录，同时也收载于中国《化学药品参比制剂目录》。国内方面，已有超过30家企业的比沙可啶原料药在CDE完成登记（A状态），获批上市的制剂涵盖肠溶片、栓剂等多个剂型，可充分满足临床及OTC市场需求。（数据截至2024年9月，最新请以CDE官网为准）

CATO/佳途科技提供比沙可啶API全套杂质标准品，可覆盖从研发到注册申报的全流程质控需求。大部分产品现货供应，现货产品16:00前下单当天发货，所有标准品均符合中国药典、FDA等多法规合规要求，可帮助研发及生产企业有效缩短杂质研究周期，降低注册申报风险。