2025年12月04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（无水合物）的《化学原料药上市申请批准通知书》（登记号Y20240000273）。我司获批上市全品类吸入制剂用API又新增一重磅产品。
糠酸莫米松（Mometasone furoate）是一种局部应用的中效糖皮质激素。它的核心作用是抗炎、抗过敏、抗增生和止痒。用于预防和治疗季节过敏性或常年性鼻炎，也可用于对皮质激素治疗有效的皮肤病。
糠酸莫米松原料药可用于多种剂型：主要有鼻喷雾剂、乳膏、凝胶剂、吸入粉雾剂等。我司生产的糠酸莫米松（Mometasone furoate），满足多种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 API Approved By NMPA
On December 4, 2025, Breathgreen Pharmaceutical Co., Ltd. (Shandong) received the Chemical Active Pharmaceutical Ingredient (API) Market Authorization Approval Notice for Mometasone Furoate (anhydrous) from the National Medical Products Administration (NMPA) (Registration No. Y20240000273). This approval marks a significant milestone for the company, adding a high-value product to its portfolio of API offerings for inhalation formulations.
Registration No. |
Product Name |
Company Name |
Address |
Update Date |
Approval Result |
Y20240000273 |
Mometasone Furoate |
Breathgreen Pharmaceutical Co., Ltd. |
No. 18 Huashan Road East, Chemical Industry Park, Eshan Town, Yicheng District, Zaozhuang City, Shandong Province, China. |
2025-12-04 |
A |
Mometasone Furoate is a medium-potency corticosteroid for topical use, primarily known for its anti-inflammatory, anti-allergic, anti-proliferative, and anti-pruritic properties. It is used in the prevention and treatment of seasonal and perennial allergic rhinitis and can also be applied in the management of dermatological conditions responsive to corticosteroid therapy.
The Mometasone Furoate API produced by our company is suitable for various dosage forms, including nasal sprays, creams, gels and dry powder inhalers (DPIs). Our advanced GMP-compliant micronization technology ensures that our product meets the stringent quality requirements of both generic and innovative formulations, providing a reliable foundation for the safety and efficacy of these treatments. This technology also supports regulatory filing and submission for drug registration, further enhancing the development of high-quality pharmaceutical products.
