Iopromide

As a second-generation non-ionic low-osmolar contrast agent, iopromide greatly improves the safety of intravascular administration by reducing the osmotic pressure of the contrast agent and minimizing adverse reactions caused by ionic dissociation. At present, it is widely used in clinical examination scenarios such as CT enhanced scan, angiography and urography, and can also be used for body cavity imaging such as articular cavity and fistula imaging. Its applicable population covers adult patients and children in need of imaging examinations, making it one of the iodine-containing contrast agent varieties with the highest clinical use frequency at present.Currently, the global market size of iopromide exceeds USD 1.2 billion, with the Chinese market accounting for approximately 24%, and the compound annual growth rate remains at 4.2%, which is mainly driven by the expansion of demand for imaging examinations under hierarchical diagnosis and treatment and the increase in the volume of CT examinations in physical examination centers of public hospitals. In terms of the competitive landscape, the original research drug still occupies 68% of the market share in the domestic market. Domestic generic drugs have successively passed the consistency evaluation since 2021, and 7 local enterprises have obtained approval for the preparation so far. After the centralized procurement, the winning bid price has dropped by up to 72% compared with that of the original research drug, and the process of domestic substitution continues to accelerate.The original research enterprise of iopromide is Bayer Healthcare, and the trade name of the original research drug is "Ultravist". Its core compound patent expired in China in 2006, and the preparation patent expired in 2016. The main dosage form approved for the original research drug is injection, with four specifications including 10ml:3g, 50ml:15g, 100ml:30g and 100ml:37g. It has been included in the Reference Listed Drug Catalogue of China Listed Medicines and is also included in the FDA Reference Listed Drug Catalogue. Up to now, there are 14 registration entries of iopromide on the API Registration Platform of CDE, among which 9 have passed the status of joint review and approval with preparations (Status A), and 11 generic varieties of iopromide injection have been approved for marketing in China. (Data as of September 2025, please refer to the official CDE website for the latest information)In response to the R&D and quality control needs of iopromide, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the relevant needs of pharmaceutical enterprises in R&D, registration and declaration, and daily quality testing.

目前全球碘普罗胺市场规模超12亿美元，中国市场约占24%，年复合增长率保持在4.2%，主要受分级诊疗下影像检查需求扩容、公立医院体检中心CT检查量上升驱动。竞争格局方面，国内市场原研仍占据68%的市场份额，国产仿制药自2021年起陆续通过一致性评价，目前已有7家本土企业获批制剂，集采后中标价格较原研最高下降72%，国产替代进程持续加速。

碘普罗胺原研企业为拜耳医药，原研商品名为“优维显”，其核心化合物专利在我国已于2006年到期，制剂专利于2016年到期。原研获批的主要剂型为注射剂，规格包括10ml:3g、50ml:15g、100ml:30g、100ml:37g四种，已列入中国上市药品目录集参比制剂，同时收载于FDA参比制剂目录。截至当前，CDE原料药登记平台共有14条碘普罗胺登记信息，其中9条已通过与制剂共同审评审批状态（A状态），国内已有11个碘普罗胺注射液仿制药品种获批上市。（数据截至2025年9月，最新请以CDE官网为准）

针对碘普罗胺的研发与质量控制需求，CATO/佳途科技可提供该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，所有产品均符合中国药典、FDA等多法规体系的合规要求，可充分满足药企研发、注册申报及日常质量检测的相关需求。