Perindopril

Cardiovascular diseases are a category of chronic diseases with high incidence worldwide. The excessive activation of the renin-angiotensin-aldosterone system (RAAS) is one of the core pathological mechanisms for the progression of diseases such as hypertension and heart failure. Perindopril is a third-generation angiotensin-converting enzyme inhibitor (ACEI). It reduces the production of angiotensin Ⅱ by competitively inhibiting the activity of ACE, and meanwhile inhibits the degradation of bradykinin, with the effects of dilating blood vessels, reducing peripheral resistance and improving ventricular remodeling. It is clinically used for the treatment of hypertension and congestive heart failure, and can also be used to reduce the risk of cardiovascular events in patients after acute myocardial infarction and patients with diabetes complicated with nephropathy. The applicable population covers adult hypertension patients and chronic disease patients with combined high cardiovascular risk factors.

At present, the global market size of perindopril-related preparations is approximately US$2.6 billion. Driven by the rising prevalence of chronic diseases and the popularization of primary-level medication, the compound annual growth rate is maintained at around 3.2%. In terms of the domestic market, with the implementation of requirements for improving the hypertension control rate, the sales of perindopril in public medical institutions exceeded RMB 1.8 billion in 2023, among which generic drugs accounted for 62%. In the fifth batch of national centralized drug procurement, the average winning bid price of perindopril tert-butylamine tablets decreased by 72% compared with that before the centralized procurement, which further promoted the accessibility of primary-level medication, and the domestic demand for API has been increasing year by year with the expansion of generic drug production capacity.

The original developer of perindopril is Servier in France, with the original brand name "Acertil". The core compound patent expired in 2004 in major markets such as Europe and the United States, and the Chinese compound patent expired in 2003. The main dosage form of the original drug is tablet, including three specifications of 2mg, 4mg and 8mg (calculated as perindopril tert-butylamine). The original preparation has been included in the *Catalogue of Reference Preparations of Chemical Drugs* in China, and is also a reference preparation recognized by the FDA. Up to now, there are 12 valid registration numbers related to perindopril on the API registration platform of China's CDE, among which 7 are in status A and can be supplied to domestic preparation manufacturers for use. 28 domestic enterprises have obtained approval for perindopril-related preparation varieties. (Data as of November 2024, please refer to the official CDE website for the latest data)

CATO can provide a full set of perindopril impurity reference standards, covering a total of 17 kinds of synthesis process impurities and degradation impurities. Most of the products 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 compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can meet the demands of the whole process such as registration and declaration, quality research and release testing.