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Zhejiang Xianju Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”) is pleased to announce that its wholly-owned subsidiary, Taizhou Xianju Pharmaceutical Co., Ltd. (hereinafter referred to as “Taizhou Xianju”), underwent a cGMP (Current Good Manufacturing Practice) on-site inspection by the U.S. Food and Drug Administration (hereinafter referred to as “FDA”) from November 11 to 15, 2024. Recently, Taizhou Xianju has received the Establishment Inspection Report (EIR) from the FDA, which confirms the conclusion of the inspection in accordance with the provisions of the U.S. Code of Federal Regulations Title 21 (21 CFR). Taizhou Xianju has successfully passed the inspection. The relevant information is hereby announced as follows:

 I. Information on the FDA On-site Inspection

•  Company Name: Taizhou Xianju  Pharmaceutical Co., Ltd.
•  Production Address: No. 3 Donghai Fourth Avenue, Zhejiang Toumen Port Economic Development Zone,Linhai City, Taizhou, Zhejiang, 317016, China
•  FDA FEI: 3012045665
•  Inspection Date: November 11-15, 2024
•  Type of Inspection: Routine Regulatory Inspection
•  Scope of Inspection: Active pharmaceutical ingredients (APIs) including Rocuronium Bromide, Vecuronium Bromide, Prednisone, and Hydrocortisone, etc
•  Inspection Result: NAI (No Action Indicated)

 The successful passing of this inspection indicates that Taizhou Xianju's quality system meets the requirements of the FDA. This achievement provides a solid foundation for the Company's continuous expansion into international markets, enhances the international competitiveness of its APIs, and positively contributes to the overall competitiveness and future development of the Company.