Ilaprazole

Addressing the clinical pain point of recurrent acid-related diseases such as reflux esophagitis and peptic ulcer, the research and development of a new generation of proton pump inhibitors (PPIs) has long been a key direction in the field of gastroenterology. Ilaprazole is a benzimidazole PPI that selectively inhibits the activity of H+/K+-ATPase in gastric parietal cells, blocking the final step of gastric acid secretion at the source. Compared with traditional PPIs, it has the advantages of a longer half-life, more stable acid suppression effect, and less individual variation. It is mainly used clinically to treat duodenal ulcer and reflux esophagitis, and can also be used in combination therapy to eradicate *Helicobacter pylori*. Its applicable population covers adult patients with acid-related diseases, especially those who respond poorly to traditional PPIs.

At present, the overall domestic market size of ilaprazole has exceeded 2.5 billion yuan, with a compound annual growth rate of around 12% in the past three years, making it one of the single products with a leading growth rate in the gastroenterology field. Its oral preparations have been included in the National Medical Insurance Catalog. With the advancement of the volume-based procurement policy, the penetration rate of generic drugs has gradually increased, and the market demand for the active pharmaceutical ingredient (API) has expanded simultaneously. Currently, the core API production capacity of this variety is mainly concentrated in leading domestic pharmaceutical enterprises. After the patent expiration, the number of applications from downstream generic pharmaceutical enterprises has continued to increase, and the demand for APIs with high compliance and complete impurity profiles as well as supporting reference standards has continued to rise.

CATO can provide a complete set of impurity reference standards for ilaprazole API. All series of products meet the quality requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support API registration and declaration, quality research, and routine quality control testing. In addition, the full product line has sufficient stock in place, which can quickly respond to various procurement needs of downstream pharmaceutical enterprises and R&D institutions, helping customers shorten project cycles and reduce compliance risks.