Captopril

Hypertension, the chronic cardiovascular disease with the highest prevalence globally, continues to drive the upgrade of clinical demand for angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs. As the first marketed ACEI drug, captopril competitively inhibits the activity of angiotensin-converting enzyme to reduce the production of angiotensin Ⅱ, and meanwhile inhibits the degradation of bradykinin. It has multiple effects of dilating blood vessels, reducing peripheral resistance and improving ventricular remodeling. Clinically, it is not only used as the first-line treatment for all types of hypertension, but also applicable to patients with heart failure and left ventricular dysfunction after acute myocardial infarction, especially for the hypertension population with concomitant diabetes and kidney diseases. It is a classic basic drug in the cardiovascular field.

As a mature antihypertensive product that has been on the market for more than 40 years, the current global market size of captopril is stable at around USD 320 million, of which generic drugs account for more than 95%. China is the core supplier of captopril active pharmaceutical ingredients (APIs), with its production capacity accounting for more than 75% of the total global production capacity. Driven by the centralized procurement policy in the domestic market, the terminal price of preparations has dropped by more than 90%, and the accessibility of medication has been greatly improved. In recent years, the annual growth rate of the consumption volume in the primary market has remained at around 8%, and the demand side of APIs shows stable and rigid characteristics.

The original research enterprise of captopril is Bristol-Myers Squibb, and the original trade name is Capoten®. The core compound patent expired globally in 1996. The main dosage form of the original drug is tablet, with specifications covering 12.5mg, 25mg and 50mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA Reference Preparation Catalogue. In terms of domestic API registration, currently captopril APIs from more than 20 enterprises have obtained A status through CDE registration, and more than 300 domestic approval documents for captopril oral preparations have been approved for marketing. The winning enterprises in centralized procurement are mainly domestic generic pharmaceutical enterprises. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of captopril 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. They meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can effectively support pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.