Budesonide

The long-term control of chronic respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) has always been the core clinical demand in the respiratory field. As a glucocorticoid anti-inflammatory active pharmaceutical ingredient, budesonide binds to glucocorticoid receptors to inhibit the release of inflammatory mediators and reduce airway mucosal edema and hyperresponsiveness. It is currently a representative inhaled corticosteroid with the strongest local anti-inflammatory activity and relatively low systemic adverse reactions. It is not only used for the long-term maintenance treatment of asthma in adults and children, but also can be formulated into nasal dosage forms to relieve allergic rhinitis. Some of its dosage forms are also used for the intervention of autoimmune inflammations such as Crohn's disease, making it one of the basic varieties in the medication system for respiratory diseases.

The global market size of budesonide has been stably above USD 3 billion for many years. The growth rate of the Chinese market has remained at 7%–9% in recent years, and the domestic terminal sales exceeded RMB 6 billion in 2023. In terms of the competitive landscape, the original research product has long dominated the mid-to-high-end market. With the expiration of patents, domestic generic drug companies have accelerated their layout. At present, more than 20 enterprises have obtained marketing approval for budesonide preparations. The inhaled solution has been included in the national centralized procurement, and the winning bid price has dropped by more than 80% compared with the original research product, which has greatly improved the medication accessibility for primary-level patients.

The original research enterprise of budesonide is AstraZeneca, and the original brand name is "Pulmicort". The core compound patent of the original research product expired globally as early as 2008, and the core preparation patent in China expired in 2021. The main marketed dosage forms of the original research product include inhaled suspension (0.5mg/2ml, 1mg/2ml), nasal spray (32μg/spray, 64μg/spray), and aerosol, etc. All relevant dosage forms have been included in the FDA Reference Listed Drug Catalog, and also included in the China Catalog of Reference Preparations for Chemical Drugs. In terms of API registration, more than 30 registration entries of budesonide API can be queried on the CDE platform at present, among which domestic registration numbers account for more than 70%, and a number of domestic generic drug preparations have been approved for marketing after passing the consistency evaluation. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for budesonide API. Most products are in stock, and 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 provide stable reference standard support for pharmaceutical enterprises in the whole process of API R&D, quality research and registration.