Bromisoval

For people with sleep disorders, drugs with dual effects of sedative-hypnotic and muscle relaxation are important clinical options for improving sleep quality. Bromisoval belongs to carbamate sedative-hypnotics, which exerts its effects by inhibiting synaptic transmission in the central nervous system and reducing neuronal excitability. It can not only shorten sleep latency and reduce the number of night awakenings, but also relieve anxiety insomnia accompanied by muscle tension, and is widely used in the short-term treatment of insomnia in adults and as an adjuvant drug for preoperative sedation.At present, the global market size of sedative-hypnotics has exceeded 45 billion US dollars, among which the annual compound growth rate of non-benzodiazepine and heterocyclic hypnotic drugs reaches 6.2%. Bromisoval maintains a steady growth in the segmented track by virtue of its advantages of low incidence of adverse reactions and low risk of addiction. The domestic market is still dominated by imported API supplies at the current stage, and 3 enterprises have submitted applications for generic preparations. With the continuous release of clinical demand, the space for domestic substitution is gradually expanding.The original research enterprise of bromisoval is Bayer AG in Germany, and the original brand name is Bromisovalum. The core compound patent expired globally in the 1970s. At present, the mainstream dosage form is tablet, with a conventional specification of 300 mg per tablet, and the original research preparation has been included in the reference preparation catalog of the EU EMA. No original research preparation has been approved for marketing in China yet. Up to now, the CDE API Registration Platform has not received the A-status registration number of bromisoval, and only 1 enterprise has submitted the I-status application. The domestic marketing progress of preparations needs to be promoted. (Data as of October 2024, please refer to the official CDE website for the latest information)CATO provides a full set of bromisoval impurity reference standards, most of which 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 provide stable reference standard support for API R&D, quality research and consistency evaluation work.

目前全球镇静催眠药市场规模已超450亿美元，其中非苯二氮䓬类及杂环类催眠药物年复合增长率达6.2%，溴米索伐凭借不良反应发生率低、成瘾风险小的优势，在细分赛道保持稳定增长。国内市场现阶段仍以进口原料药供应为主，已有3家企业提交仿制制剂申报，随着临床需求的持续释放，国产化替代空间逐步扩大。

溴米索伐的原研企业为德国拜耳公司，原研商品名为Bromisovalum，核心化合物专利已于20世纪70年代全球到期。目前主流剂型为片剂，常规规格为300mg/片，原研制剂已被列入欧盟EMA参比制剂目录。国内尚未有原研制剂获批上市，截至当前CDE原料药登记平台暂未收到溴米索伐的A状态登记号，仅1家企业提交I状态申报，国内制剂上市进度有待推进。（数据截至2024年10月，最新请以CDE官网为准）

CATO/佳途科技提供溴米索伐全套杂质标准品，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，为原料药研发、质量研究及一致性评价工作提供稳定的对照品支持。