Formoterol

Asthma and chronic obstructive pulmonary disease (COPD) are highly prevalent chronic respiratory diseases, and long-term controlled treatment has always been a core clinical need. Formoterol is a long-acting β₂ receptor agonist for respiratory system use. It acts by highly selectively stimulating β₂ adrenergic receptors on airway smooth muscle, relaxing airway smooth muscle and inhibiting the release of inflammatory mediators such as those from mast cells. It has the dual advantages of rapid onset of action (onset within 3 minutes) and long duration of action (over 12 hours). It is a core basic medication in the clinical stepwise treatment of moderate to severe asthma and COPD. It is often formulated into a compound preparation with glucocorticoids for long-term maintenance treatment of adults and adolescents over 12 years old, which can significantly reduce the frequency of acute attacks and improve patients' lung function and quality of life.

In recent years, the global market for respiratory disease medications has expanded steadily. The global market size of formoterol-related preparations in 2023 was approximately USD 2.2 billion, and the market size in China exceeded RMB 1.8 billion, with a compound annual growth rate of around 7%. In the current domestic market, the original research product still accounts for nearly 60% of the market share. With the increase in the number of approved generic preparations after patent expiration, coupled with the successive inclusion of respiratory drugs in the centralized procurement scope, the market share of domestic preparations is increasing year by year, and the demand for high-quality compliant active pharmaceutical ingredients (APIs) continues to be released accordingly.

The original research enterprise of formoterol is AstraZeneca, with the original trade name "Oxis Turbuhaler". Its core compound patent expired in the European and American markets in 2019, and the compound patent in China expired in 2010. The main dosage form approved for the original research product is dry powder inhaler, with a specification of 4.5 μg per actuation. The original research formoterol powder for inhalation has been included in the China Listed Medicines Catalogue, and is the reference preparation for domestic preparation research and development. As of now, there are 17 registration entries of formoterol API on the CDE API registration platform, among which 9 have been activated with A status. Multiple domestic enterprises have obtained marketing approval for formoterol single-agent and compound inhalation preparations. (Data as of May 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for formoterol API, with most products available in stock. Orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process demands of API and preparation enterprises in research and development, production and quality control.