Imidapril

Hypertension, as a high-prevalence chronic cardiovascular disease, continuously threatens the health of more than 1.2 billion patients worldwide. Angiotensin-converting enzyme inhibitors (ACEI) are one of the core categories of clinical antihypertensive treatment. Imidapril belongs to the third-generation ACEI drugs. It exerts a stable antihypertensive effect by inhibiting the activity of angiotensin-converting enzyme, reducing the production of angiotensin Ⅱ, and inhibiting the degradation of bradykinin, and has both cardiac and renal protective effects. In addition to essential hypertension, this drug can also be used to improve the prognosis of patients with hypertension complicated by chronic renal insufficiency and type 2 diabetes mellitus, and is suitable for adult patients who need long-term blood pressure control. The incidence of adverse reactions such as cough is significantly lower than that of the first-generation ACEI drugs.

At present, the global market size of imidapril is stable at around USD 120 million, with the Chinese market accounting for approximately 32%, and the compound annual growth rate in the past three years has maintained at 4.7%. Due to its clear clinical positioning and outstanding cost-effectiveness, the drug has been included in the National Medical Insurance Catalog (Class B), and the demand in the primary market continues to be released. In terms of competitive landscape, the domestic preparation market is still dominated by original research products. Three local enterprises have obtained marketing approvals for generic drugs, all of which have passed the consistency evaluation. With the advancement of the generic drug substitution process, the demand for active pharmaceutical ingredients will maintain steady growth in the future.

The original research enterprise of imidapril is Japan's Tanabe Mitsubishi Pharma Corporation, and the original brand name is "Tanaske". Its core compound patents in major markets such as Japan and the United States expired in 2007, and the relevant compound patents in China also expired in 2007. The dosage form approved by the original research is tablets, with specifications of 5mg and 10mg, and the tablets have been included in the *Reference Preparation Catalog of Chemical Drugs* issued by the National Medical Products Administration. Up to now, there are 4 pieces of imidapril API registration information on China's CDE API Registration Platform, 2 of which are in status A and can be supplied for domestic preparation production. A number of preparation varieties including original research and generic drugs have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for imidapril, most of which are available in stock. Orders placed before 16:00 can be shipped on the same day. All products comply with the regulatory requirements of drug regulatory authorities of multiple countries such as the Chinese Pharmacopoeia and FDA, and fully meet the full-process R&D and production needs of API and preparation enterprises in quality research, consistency evaluation and other aspects.