2025年12月04日，博澤格霖（山東）藥業有限公司（BREATHGREEN PHARMACEUTICAL CO., LTD.）收到國家藥品監督管理局（NMPA）的糠酸莫米松（無水合物）的《化學原料藥上市申請批準通知書》（登記號Y20240000273）。我司獲批上市全品類吸入制劑用API又新增一重磅產品。
糠酸莫米松（Mometasone furoate）是一種局部應用的中效糖皮質激素。它的核心作用是抗炎、抗過敏、抗增生和止癢。用于預防和治療季節過敏性或常年性鼻炎，也可用于對皮質激素治療有效的皮膚病。
糠酸莫米松原料藥可用于多種劑型：主要有鼻噴霧劑、乳膏、凝膠劑、吸入粉霧劑等。我司生產的糠酸莫米松（Mometasone furoate），滿足多種制劑產品的工藝要求，特有的GMP微粉化技術可更好的保障仿制制劑及創新制劑安全性和有效性，為制劑注冊申報提供更好的保障。
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.
