近日，我司旗下的糠酸氟替卡松原料药顺利通过日本药品和医疗器械管理局（PMDA）技术审评，助力制剂客户成功获批！

此前，该产品已于 2025 年 8 月底圆满通过 PMDA 现场审计，此次获批是对公司研发实力、规模化生产能力、GMP 合规管理水平、国际注册及全球供应能力的权威认证。

 作为吸入性糖皮质激素（ICS）类药物之一，糠酸氟替卡松凭借其17α-糠酸基团结构，具有更强的受体亲和力与抗炎活性，适用于过敏性鼻炎、哮喘及慢性阻塞性肺疾病（COPD）的治疗。

博泽格霖深耕吸入制剂用原料药领域，可供应全品系吸入原料及粉体定制化服务，始终以 “国际化品质” 为核心战略；目前，公司产品已获中国、欧洲、日本等主流市场批准，为制剂客户提供更广阔的市场布局支持。

未来，公司将持续精进技术与服务，坚守国际标准，稳定供应高品质原料药，与全球制剂企业携手拓展国际市场，丰富优质用药选择。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.