Benazepril

As one of the core medications for chronic hypertension management globally, benazepril belongs to the angiotensin-converting enzyme inhibitor (ACEI) class of drugs. It exerts the effects of dilating blood vessels and reducing peripheral vascular resistance by inhibiting the activity of angiotensin-converting enzyme, decreasing the production of angiotensin II, and suppressing the degradation of bradykinin. Clinically, in addition to being used for the treatment of primary hypertension at all stages, it can also improve ventricular remodeling in patients with congestive heart failure and reduce the incidence of adverse cardiovascular events. Its applicable population covers hypertension patients with comorbid diabetes and renal insufficiency (creatinine clearance ≥ 30ml/min), and it is a first-line therapeutic drug recommended by multiple domestic and foreign hypertension guidelines.

The global market size of benazepril-related preparations is approximately USD 1.3 billion. In recent years, with the continuous rise in the prevalence of hypertension, the market has maintained a compound annual growth rate of 2.3%. In terms of the domestic market, benazepril is one of the first batch of varieties included in the national centralized drug procurement. After the centralized procurement, the overall accessibility of the drug has been greatly improved. At present, the market share of domestic generic preparations has exceeded 75%, the demand for upstream API is stable, and domestic enterprises have formed large-scale supply advantages in API production.

The original developer of benazepril is Novartis, with the original brand name "Lotensin". Its core compound patent in China expired in 2011. The main marketed dosage form of the original drug is tablet, with specifications of 5mg and 10mg. The original tablet has been included in the China Listed Drug Catalogue as the reference listed drug. Up to now, more than 20 domestic enterprises have obtained CDE registration for benazepril API, and those with the registration status of A can be used in association with marketed drugs. The domestically approved benazepril preparations are mainly oral tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of benazepril 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 comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet the needs of API enterprises in quality research, consistency evaluation and impurity control in the production process.