Budesonide

As highly prevalent chronic respiratory diseases, bronchial asthma and chronic obstructive pulmonary disease (COPD) require long-term reliance on glucocorticoid drugs to control the progression of inflammation. Budesonide is exactly the most widely used representative inhaled glucocorticoid in clinical application among such drugs. It exerts its effects by inhibiting the release of inflammatory mediators and reducing airway mucosal edema and hyperresponsiveness. It is not only used for the long-term maintenance treatment of asthma in adults and children, but also can alleviate the risk of acute exacerbation in COPD patients. Due to its strong local anti-inflammatory effect and low systemic adverse reactions, it is listed as a first-line drug for respiratory diseases in the diagnosis and treatment guidelines of many countries.

At present, the global market size of budesonide API has exceeded 400 million US dollars, with an annual compound growth rate maintained at around 5%. The core driving factors come from the rising prevalence of respiratory diseases and the continuous release of demand for children's asthma medication. The competitive landscape of the domestic market is relatively concentrated, with the supply of generic drugs accounting for more than 85%. With the normalized implementation of centralized procurement after the expiration of the original research patent, the demand of winning bidders for high-quality APIs and supporting impurity research resources has increased significantly, and there is still an obvious gap in the compliant supply of relevant impurity reference standards at the current stage.

CATO can provide a full set of impurity reference standards for budesonide API. All products meet the quality requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, with sufficient spot reserves. They can directly meet the full-process use needs of enterprises such as registration and declaration, quality research, and batch release, without additional waiting for customized production cycles, helping relevant pharmaceutical companies to efficiently promote product R&D and commercialization.