Carbuterol

As a highly selective β₂ adrenoceptor agonist, carbuterol can effectively relax bronchial smooth muscles and inhibit the release of inflammatory mediators by activating β₂ receptors on airway smooth muscles, and has the characteristics of mild onset and long duration of action. It is mainly used clinically for symptom control of respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease (COPD) and asthmatic bronchitis, and is suitable for adult and adolescent patients over 12 years old who need long-term maintenance of airway dilation and reduction of the frequency of acute attacks. Compared with short-acting β₂ agonists, it can significantly reduce the risk of nocturnal attacks and improve the quality of life of patients.

At present, the global market size of respiratory disease drugs continues to expand, and the annual compound growth rate of long-acting β₂ agonist API is maintained at about 4.2%. Due to its clear clinical positioning, the market demand for carbuterol is rising steadily, but its overall commercialization degree is still in the rising period. At present, the global API production capacity is mainly concentrated in a small number of compliant enterprises in Europe, India and China. The development of domestic generic drugs is still in its infancy, and there are no publicly verifiable statistical data on the segmented market size.

The original research enterprise of carbuterol is Orion Corporation of Finland, and the original trade name is Bexol. Its core compound patent expired in Europe in 2018, and the core patent in the US market expired in 2019. The main dosage form approved by the original research is oral tablet, with a conventional specification of 2mg per tablet, and this original research tablet has been included in the EU reference preparation catalog. As of the current retrieval time, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China has not publicly announced the carbuterol API that has obtained the A-status registration number, and no carbuterol preparation has been approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for carbuterol, and most products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of reference standards in the whole process of generic drug development, quality research and registration application for pharmaceutical enterprises.