Salbutamol

As a common chronic respiratory disease worldwide, bronchial asthma affects more than 300 million patients. Albuterol is a first-line short-acting β₂ receptor agonist for the treatment of such diseases. By selectively activating β₂ adrenoceptors on airway smooth muscle, it rapidly relaxes the smooth muscle and dilates the bronchi, usually relieving the symptoms of bronchospasm within a few minutes. In addition to being used for the control of acute attacks of bronchial asthma, it is also suitable for the treatment of diseases accompanied by airway spasm symptoms such as chronic obstructive pulmonary disease and asthmatic bronchitis, and is one of the core medications for emergency scenarios for asthma patients.

In recent years, the global albuterol market size has been stable at more than 3 billion US dollars. Driven by the rising prevalence of respiratory diseases and the improved accessibility of emergency medications in developing countries, the compound annual growth rate has remained at around 4%. In terms of the domestic market, albuterol aerosol has been included in the national centralized procurement. The winning bid price has dropped by more than 70% compared with the previous level, driving the continuous increase in medication coverage. At present, there are more than 30 domestic preparation manufacturers, and domestic enterprises have dominated the raw material supply side, with only a small number of high-end inhalation dosage form raw materials still dependent on imports.

The original developer of albuterol is GlaxoSmithKline, and the original brand name is "Ventolin". Its core compound patent expired globally in 1986. Currently, the marketed original dosage forms mainly include inhalation aerosol, inhalation solution and injection. Among them, the 100μg/puff inhalation aerosol and the 2.5ml:2.5mg inhalation solution have been included in the China Listed Drugs Catalog as reference preparations, and are also included in the FDA Reference Preparations List. In terms of domestic API registration, more than 20 enterprises have obtained approval for albuterol API through CDE registration, and there are more than 60 domestic preparation approvals, which can fully meet the domestic clinical medication demand. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of albuterol impurity reference standards. Most products are in stock. Orders placed before 16:00 can be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and preparation consistency evaluation.