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博泽格霖药业糠酸莫米松(一水合物)原料药获批



     2026年3月6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)的糠酸莫米松(一水合物)的《化学原料药上市申请批准通知书》(登记号Y20240000274)。我司获批上市全品类吸入制剂用API又新增一重磅产品。




备注:品种名称“糠酸莫米松”实际为“糠酸莫米松一水合物”。 

    糠酸莫米松(一水合物)(Mometasone Furoate Monohydrate)是糖皮质激素类药物,具有抗炎抗过敏等作用,可以减少炎症介质,减轻机体对免疫复合物和迟发型超敏反应的应答。用于预防和治疗季节过敏性或常年性鼻炎。   

    我司生产的糠酸莫米松(一水合物)(Mometasone Furoate Monohydrate),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 Mometasone Furoate Monohydrate API Approved By NMPA

    Mometasone Furoate Monohydrate (Registration No. Y20240000274) has received the NMPA’s Approval on March 6, 2026. It marks the addition of one more flagship product to our company's inhalation API series.



    Note: The product name "Mometasone Furoate" actually refers to "Mometasone Furoate Monohydrate".
 
    Mometasone Furoate Monohydrate is aglucocorticoid preparations with anti-inflammatory and anti-allergic activities. They reduce inflammatory mediators and attenuate the body’s responses to immune complexes and delayed-type hypersensitivity reactions. They are indicated for the prophylaxis and treatment of seasonal and perennial allergic rhinitis.

    Manufactured by our company, Mometasone Furoate Monohydrate 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.


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