Iodixanol

In the imaging diagnosis process of cardiovascular and cerebrovascular diseases and peripheral vascular diseases, the application of iso-osmolar contrast agents is one of the core strategies to reduce contrast-induced acute kidney injury and anaphylactoid reactions. Iodixanol is a third-generation non-ionic dimeric iso-osmolar X-ray contrast agent, whose osmotic pressure is completely equal to that of human blood. After entering the human body, it will not cause osmotic damage to vascular endothelial cells and red blood cells, and can be completely excreted in the original form through the kidneys. It is widely used clinically in coronary angiography, peripheral arteriography and intravenous urography in adults, as well as cardiovascular angiography and head and neck contrast-enhanced CT scans in children, and is especially suitable for high-risk contrast populations with diabetes mellitus and chronic renal insufficiency.

At present, the global market size of iodixanol is stable at more than 1.2 billion US dollars. As one of the markets with the fastest growing demand for imaging examinations, China maintains an annual growth rate of about 8%, and its domestic terminal market size exceeded 4 billion yuan in 2023. In terms of the competitive landscape, the original research product has long occupied more than 60% of the market share. With the advancement of the consistency evaluation of generic drugs, the market share of domestic generic drugs has increased to 45%. On the upstream API side, there are currently less than 10 domestic enterprises with large-scale supply capacity, and the overall supply concentration is relatively high. With the improvement of the penetration rate of CT examinations in primary medical institutions, there is still room for the continuous release of API demand.

The original research enterprise of iodixanol is GE Healthcare, and the original trade name is Visipaque. Its compound patent in China expired in 2018, and its preparation patent expired in 2021. The main dosage form approved for the original research product is injection, with specifications including 10ml:3.2g, 20ml:6.4g, 50ml:16g, 100ml:32g and other gradients. It has been included in the *Catalogue of Reference Preparations of Chemical Medicines* of China, and also included in the FDA Reference Preparations Catalogue. Up to now, more than 15 domestic enterprises have obtained Grade A status for their iodixanol APIs through CDE registration, and more than 20 domestic iodixanol injections have been approved for marketing and passed the consistency evaluation. (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 iodixanol API, covering all process impurities and degradation impurities that may be generated during the synthesis process. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can directly support API quality research, consistency evaluation and registration declaration work.