Droperidol

Perioperative nausea and vomiting (PONV) is a common postoperative complication of surgical procedures, with an incidence rate of 20% to 30%, and even over 80% in high-risk groups. It not only increases patients' discomfort, but also may cause severe complications such as wound dehiscence and electrolyte imbalance. Droperidol belongs to butyrophenone antipsychotics. It exerts a potent antiemetic effect through the antagonistic action on central dopamine D2 receptors and 5-hydroxytryptamine receptors, and also has a mild sedative effect, making it a first-line drug for the prevention of PONV at present. In addition to perioperative application, it can also be used to control the excited and restless state of schizophrenia and mania. It is also often used as an anesthetic adjuvant in combination with analgesics for ICU sedation, endoscopic examination and other scenarios.According to public data, the market size of antiemetic APIs in China was approximately RMB 1.87 billion in 2023, among which dopamine receptor antagonists accounted for nearly 22%. As a classic antiemetic, droperidol has maintained a compound annual growth rate of market demand of around 7.2% in the recent 3 years, and the main driving factors come from the steady increase in the surgical volume of tertiary hospitals and the promotion of day surgery and outpatient surgery. At present, the domestic supply of droperidol API is dominated by generic pharmaceutical companies, and no API from original research manufacturers is marketed in China. A total of 3 enterprises have completed API registration through CDE, and the market competition pattern is relatively concentrated.The original research manufacturer of droperidol is Janssen Pharmaceuticals, with the original brand name Inapsine. The core compound patent in the US market expired in 1980, and there is no valid compound patent in China. The main dosage form approved by the original research manufacturer is injection, with two specifications of 2.5mg/ml and 5mg/ml. The original research injection has not been approved for marketing in mainland China. Currently, all droperidol injections marketed in China are domestic generics. The reference preparation is included in the FDA Orange Book, and there is no imported reference preparation filed in China. As of October 2024, there are 3 A-status registration numbers for droperidol on the CDE API registration platform, all held by domestic enterprises. (Data as of October 2024, please refer to the official CDE website for the latest information)CATO provides a full set of impurity reference standards for droperidol API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and fully adapt to the full-process R&D and production quality control needs of pharmaceutical companies such as generic drug consistency evaluation, quality research, and stability testing.

据公开数据显示，2023年中国止吐类原料药市场规模约18.7亿元，其中多巴胺受体拮抗剂类占比接近22%，氟哌利多作为经典止吐药，近3年市场需求量年复合增长率保持在7.2%左右，主要驱动因素来自三级医院手术量的稳步提升及日间手术、门诊手术的推广。目前国内氟哌利多原料药供应以仿制药企为主，暂无原研企业原料药在国内上市，已通过CDE原料药登记的企业共3家，市场竞争格局相对集中。

氟哌利多的原研企业为杨森制药，原研商品名为Inapsine，美国市场核心化合物专利于1980年到期，中国境内无有效化合物专利。原研获批的主要剂型为注射剂，规格有2.5mg/ml、5mg/ml两种，原研注射剂未在中国大陆地区获批上市，目前国内上市的氟哌利多注射液均为国产仿制药，参比制剂收载于FDA橙皮书，国内暂无进口参比制剂备案。截至2024年10月，CDE原料药登记平台共有3条氟哌利多A状态登记号，均为国内企业持有。（数据截至2024年10月，最新请以CDE官网为准）

CATO/佳途科技提供氟哌利多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，可满足中国药典、FDA等多法规合规要求，充分适配药企仿制药一致性评价、质量研究、稳定性试验等全流程研发及生产质控需求。