Enalapril

Cardiovascular diseases are chronic diseases with high incidence globally, and the long-term management of hypertension and heart failure has always been the core demand of clinical attention. As a second-generation angiotensin-converting enzyme inhibitor (ACEI) drug, enalapril exerts the effects of dilating blood vessels, lowering blood pressure, and improving ventricular remodeling by inhibiting the activity of angiotensin-converting enzyme, reducing the production of angiotensin Ⅱ, and inhibiting the degradation of bradykinin at the same time. It is clinically mainly used for the treatment of primary hypertension at all stages, renovascular hypertension, and heart failure at all levels. It can also be used to prevent symptomatic heart failure and reduce the risk of myocardial infarction. The applicable population covers adult hypertensive patients and patients with combined cardiac insufficiency, and it is a first-line antihypertensive and heart failure treatment drug recommended by guidelines of many countries.

Enalapril is one of the most widely used ACEI drugs in clinical practice worldwide. Its global market size has remained above US$300 million for a long time, and the annual sales volume at the terminal of domestic public hospitals is stable in the range of RMB 800 million to RMB 1 billion. Due to the early expiration of the patent, the current global market is dominated by generic drug supply. In China, there are more than 60 enterprises holding approval documents for enalapril preparations, and more than 20 API manufacturers, so the domestic supply system is mature. As a selected品种 in the first batch of national centralized drug procurement, the clinical accessibility of enalapril has been greatly improved, and the price of selected preparations has dropped by more than 90%, driving the continuous and stable growth of demand for APIs.

The original research enterprise of enalapril is Merck Sharp & Dohme, and the original research trade name is VASOTEC (悦宁定). Its core compound patent expired in the United States in 1999. The main dosage forms approved by the original research are tablets, with specifications including 2.5mg, 5mg, 10mg and 20mg. The original research tablets have been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs*. At present, there are more than 30 domestic registration numbers for enalapril APIs, most of which are in status A and can be used for associated declaration. Multiple domestic manufacturers have obtained approval for the marketing of enalapril tablets and capsules. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of enalapril 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. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can meet the full-process needs of API enterprises in R&D, quality research and compliance declaration.