Breathgreen Pharmaceutical’s Indacaterol Maleate API Approved By NMPA

Indacaterol Maleate (Registration No. Y20240000321) has received the NMPA’s Approval on July 20, 2026. It marks the addition of one more flagship product to our company's inhalation API arsenal.

Indacaterol Maleate is a long-acting β₂-adrenoceptor agonist indicated for COPD（chronic obstructive pulmonary disease） in adults.

 

Manufactured by our company, Indacaterol Maleate meets the process requirements of relevant powder for inhalation pharmaceutical products. Using coarse API that are crystallized from the final synthesized step as primary particle in large size, we manipulate the powder property as required from clients. Our proprietary GMP-compliant micronization technology better ensures the safety and efficacy of both generic and innovative formulations, providing enhanced support for pharmaceutical registration applications.

 

As a global supplier covering all categories of APIs and excipients for inhalation formulations, our company has 19 respiratory API products in four categories under global registration. Several projects have been successfully approved. Please refer to the API registration progress table below for detailed registration status.