Carvedilol

For the long-term management of chronic cardiovascular diseases such as hypertension and heart failure, treatment regimens with dual blocking effects on both α and β receptors have always been a key direction of clinical concern. As a third-generation β-blocker cardiovascular drug, carvedilol can non-selectively block β receptors and selectively block α1 receptors, while having additional effects such as antioxidant and anti-proliferation effects. It can not only lower blood pressure and slow down heart rate, but also improve ventricular remodeling. It is suitable for patients with essential hypertension and symptomatic congestive heart failure, and can also be used for people with left ventricular dysfunction after acute myocardial infarction. It is a first-line drug recommended by multiple domestic and foreign cardiovascular disease guidelines.

Driven by the continuous rise in the prevalence of cardiovascular diseases, the market demand for carvedilol maintains a steady growth trend. At present, the global market size is approximately USD 420 million, and the Chinese market size has exceeded RMB 900 million, with a compound annual growth rate maintained at around 4.7%. In terms of the competitive landscape, the original research product still accounts for about 32% of the high-end hospital market share. Domestic generic drugs, with their higher cost-effectiveness, have covered primary medical care and retail markets. At present, more than 20 domestic enterprises have obtained the production qualification of carvedilol preparations, and the domestic supply system for related APIs has been relatively mature. After the centralized procurement, the price of preparations has dropped by more than 70%, further improving the accessibility of drugs for patients.

The original research enterprise of carvedilol is Roche, and the original trade name is "Dilatrend". Its core compound patent in the United States expired in 2007, and the Chinese compound patent also expired in the same period. The main dosage forms approved for the original research product include tablets, with specifications of 6.25mg, 12.5mg and 25mg, which have been included in the Chinese *Catalogue of Chemical Reference Preparations* and the FDA Reference Preparation Catalogue. Up to now, there have been 17 registration entries of carvedilol APIs on the API registration platform of China CDE, among which 11 are in status A and can be legally supplied for preparation production. A number of preparation varieties such as carvedilol tablets and carvedilol capsules have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for carvedilol API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs in different stages such as API R&D, quality research and consistency evaluation.