近日，我司旗下的糠酸氟替卡松原料藥順利通過日本藥品和醫(yī)療器械管理局（PMDA）技術(shù)審評，助力制劑客戶成功獲批！
此前，該產(chǎn)品已于 2025 年 8 月底圓滿通過 PMDA 現(xiàn)場審計，此次獲批是對公司研發(fā)實力、規(guī)模化生產(chǎn)能力、GMP 合規(guī)管理水平、國際注冊及全球供應能力的權(quán)威認證。
作為吸入性糖皮質(zhì)激素（ICS）類藥物之一，糠酸氟替卡松憑借其17α-糠酸基團結(jié)構(gòu)，具有更強的受體親和力與抗炎活性，適用于過敏性鼻炎、哮喘及慢性阻塞性肺疾病（COPD）的治療。
博澤格霖深耕吸入制劑用原料藥領(lǐng)域，可供應全品系吸入原料及粉體定制化服務，始終以 “國際化品質(zhì)” 為核心戰(zhàn)略；目前，公司產(chǎn)品已獲中國、歐洲、日本等主流市場批準，為制劑客戶提供更廣闊的市場布局支持。
未來，公司將持續(xù)精進技術(shù)與服務，堅守國際標準，穩(wěn)定供應高品質(zhì)原料藥，與全球制劑企業(yè)攜手拓展國際市場，豐富優(yōu)質(zhì)用藥選擇。Good News! Breathgreen’s Fluticasone Furoate API Approved by Japan PMDA
Recently, the fluticasone furoate active pharmaceutical ingredient (API) under our company has successfully passed the technical review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), supporting our formulation customers in securing approval!
Previously, this product had passed the PMDA on-site audit at the end of August 2025, and this approval serves as authoritative recognition of our company’s R&D capabilities, large-scale production capacity, GMP compliance, international registration, and global supply capabilities.
As one of the inhaled corticosteroid (ICS) drugs, fluticasone furoate, with its 17α-furoate group structure, exhibits stronger receptor affinity and anti-inflammatory activity, making it suitable for the treatment of allergic rhinitis, asthma, and chronic obstructive pulmonary disease (COPD).
Breathgreen specializes in APIs for inhalation preparations, supplying a full range of inhalation-grade raw materials and customized powder services, always adhering to “international quality” as its core strategy. Currently our products have been approved in major markets including China, Europe, and Japan, supporting formulation customers in achieving broader market expansion.
In the future, we will continue to refine our technology and services, adhere to international standards, ensure a stable supply of high-quality APIs. We look forward to collaborating with global formulation enterprises to expand into international markets and offer more high-quality medication options.
