Iomeprol

Contrast-induced nephropathy is a common iatrogenic cause of renal injury in clinical contrast procedures. Non-ionic contrast agents with low osmotic pressure and low viscosity provide a core solution to reduce such risks. Iomeprol is a third-generation non-ionic monomeric iodine contrast agent. By introducing hydrophilic groups onto the benzene ring, it significantly reduces chemical toxicity and osmotic pressure while ensuring high contrast. Its osmotic pressure is close to that of human plasma, and its irritation to vascular endothelium and renal tubules is much lower than that of traditional ionic contrast agents. It is mainly used in various imaging examinations such as intravenous urography, cerebral angiography, coronary angiography, and CT enhanced scan in clinical practice, and is also suitable for contrast procedures in high-risk groups such as elderly patients, patients with mild renal impairment, and patients with diabetes.

At present, the global market size of iodine contrast agents has exceeded 5 billion US dollars, with a compound annual growth rate of about 4.2%, among which low-osmolar non-ionic contrast agents account for more than 70%. China is the fastest-growing market for iodine contrast agents. In 2023, its market size exceeded 13 billion yuan, with an annual growth rate of 8.7%. In terms of competitive landscape, original research products account for about 35% of the market share, and domestic generic drugs continue to replace them with cost advantages. At present, more than 10 domestic enterprises have obtained production approvals for iomeprol preparations. After the volume-based procurement, the terminal price of the product has dropped by about 46%, and the accessibility has been greatly improved.

The original research enterprise of iomeprol is Bracco S.p.A. from Italy, and the original trade name is Iomeron. Its core compound patent expired globally in 2010. At present, the original dosage forms approved in China are mainly injections, with specifications covering 100ml:30g(I), 100ml:35g(I), 100ml:40g(I), etc. The original product has been included in the Catalogue of Listed Drugs of China as the reference preparation, and is also included in the FDA Reference Listed Drug Directory. In terms of API registration, as of now, 6 domestic enterprises have obtained A-status registration numbers for iomeprol APIs after approval by the CDE, and the registration numbers of another 3 enterprises are under review. A number of domestic iomeprol injection varieties have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of iomeprol 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. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the use needs of reference standards for pharmaceutical enterprises in the whole process of API R&D, quality research, consistency evaluation, etc.