Lisinopril

Hypertension is one of the chronic cardiovascular diseases with the highest prevalence worldwide. In clinical antihypertensive regimens, angiotensin-converting enzyme inhibitors (ACEI) have always occupied a core position in medication due to their concurrent target organ protective effects. As a third-generation ACEI drug, lisinopril exerts a long-acting and stable antihypertensive effect by competitively inhibiting the activity of angiotensin-converting enzyme to reduce the production of angiotensin Ⅱ, and meanwhile inhibiting the degradation of bradykinin. Its clinical indications cover essential hypertension and renal hypertension, and it can also be used for the treatment of early-stage acute myocardial infarction and heart failure. It is suitable for hypertensive patients with complications such as diabetes mellitus and nephropathy, and its advantage of no adverse reactions related to hepatic metabolism makes it particularly suitable for people with abnormal liver function.

At present, the global market size of antihypertensive drugs has exceeded 50 billion US dollars, among which ACEI drugs account for approximately 12%. As a basic medication in ACEI category, lisinopril has a stable global market size of around 1.3 billion US dollars. Driven by the centralized drug procurement policy in the domestic lisinopril market, the substitution rate of generic drugs has exceeded 90%. In 2023, the terminal sales of domestic public medical institutions were approximately 320 million yuan, and the growth rate of volume expansion in the primary market remained above 11%. At present, the domestic supply of active pharmaceutical ingredients is dominated by local enterprises, with the top 3 enterprises accounting for more than 75% of the market share. The continuous promotion of consistency evaluation has also driven the increasing demand for high-purity active pharmaceutical ingredients and impurity research.

The original developer of lisinopril is AstraZeneca, with the original brand name "Zestril". The expiration time of its core compound patent in the United States and Europe was 2002, and the compound patent in China expired in 2001. The originally marketed dosage form is tablet, with specifications including 2.5mg, 5mg, 10mg and 20mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation listed by FDA. In China, lisinopril active pharmaceutical ingredients from more than 20 enterprises have obtained Grade A status through registration with the Center for Drug Evaluation (CDE), and more than 30 additional oral lisinopril preparations have been approved for marketing, among which more than 20 product specifications have passed the quality and efficacy consistency evaluation of generic drugs. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for lisinopril API, which can cover the needs of all research scenarios such as process impurities and degradation impurities. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. The products simultaneously meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for the quality research and consistency evaluation work of pharmaceutical enterprises.