2025年12月29日，博泽格霖（山东）药业有限公司（BREATHGREEN PHARMACEUTICAL CO., LTD.）收到国家药品监督管理局（NMPA）的醋酸茚达特罗的《化学原料药上市申请批准通知书》（登记号Y20240000320）。我司获批上市全品类吸入制剂用API又新增一重磅产品。
醋酸茚达特罗（Indacaterol Acetate）是长效β2-肾上腺受体激动剂，用于成人慢性肺阻塞性疾病（COPD）的维持治疗。
我司生产的醋酸茚达特罗（Indacaterol Acetate），可满足吸入粉雾剂制剂产品的工艺要求，特有的GMP微粉化技术可更好的保障仿制制剂及创新制剂安全性和有效性，为制剂注册申报提供更好的保障。
Breathgreen Pharmaceutical’s Indacaterol Acetate API Approved By NMPA
Indacaterol Acetate (Registration No. Y20240000320) has received the NMPA’s Approval on December 29, 2025. It marks the addition of one more flagship product to our company's inhalation API arsenal
Indacaterol Acetate is a long-acting β₂-adrenoceptor agonist indicated for COPD（chronic obstructive pulmonary disease） inadults
Manufactured by our company, Indacaterol Acetate 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.
