Acebutolol

β-blockers are a basic category of drugs for chronic cardiovascular diseases such as hypertension and arrhythmia. As a representative variety of selective β₁-adrenoceptor blockers, acebutolol has intrinsic sympathomimetic activity, which can reduce heart rate and myocardial contractility while rarely causing adverse reactions such as bradycardia and bronchial smooth muscle contraction. In clinical practice, it is suitable for the long-term control of primary hypertension at all stages, and can also be used for the intervention of arrhythmias such as ventricular premature beats and sinus tachycardia. For cardiovascular patients with bronchial asthma and chronic obstructive pulmonary disease, its medication safety is better than that of non-selective β-blockers, and it is one of the preferred treatment regimens for elderly patients and patients with underlying respiratory diseases.

The global market size of acebutolol is approximately USD 210 million, with a compound annual growth rate of 3.2% in the past three years. The growth momentum mainly comes from the improvement of the coverage of primary cardiovascular disease diagnosis and treatment and the steady release of demand for chronic disease management in the elderly. In terms of competitive landscape, Europe and India are the main production regions of active pharmaceutical ingredients (APIs), accounting for 68% of the global production capacity; the domestic market is still dominated by generic drug supply. Since 2020, provincial-level centralized procurement has gradually covered the broad category of β-blockers, the number of generic drug applications for acebutolol has increased, and the demand for localization of the API supply chain continues to expand.

The original research enterprise of acebutolol is Sanofi, with the original brand name Sectral, and the core compound patent expired globally in 1999. The main approved dosage forms of the original drug include tablets and capsules, with common specifications of 200mg and 400mg, which have been included in the FDA Reference Listed Drug Catalog. In China, at present, there is no publicly announced A-state registration number of acebutolol on the CDE API Registration Platform. Only the marketing applications for preparations submitted by 2 enterprises are under review, and there is no domestic acebutolol preparation product approved for marketing. (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 acebutolol, 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 multiple regulations including Chinese Pharmacopoeia and FDA, which can fully meet the full-process testing needs of API R&D, quality research and generic drug consistency evaluation.