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）的格隆溴铵的《化学原料药上市申请批准通知书》（登记号Y20240000443）。我司获批上市全品类吸入制剂用API又新增一重磅产品。 格隆溴铵（Glycopyrronium Bromide）是抗胆碱药，具有支气管扩张作用，用于成人慢性阻塞性肺炎的维持性对症治疗。
我司生产的格隆溴铵（Glycopyrronium Bromide），可满足吸入气雾剂和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 Glycopyrronium Bromide API Approved By NMPA
Glycopyrronium Bromide (Registration No. Y20240000443) 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.
Glycopyrronium Bromide is an anticholinergic agent with a bronchodilatory effect, indicated for COPD（chronic obstructive pulmonary disease） in adults.
Manufactured by our company, Glycopyrronium Bromide 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.
