Xianju Pharmaceutical's subsidiary passes FDA inspection
Zhejiang Xianju Pharmaceutical (SZSE:002332) announced that its wholly-owned subsidiary, Taizhou Xianju Pharmaceutical, successfully completed an inspection by the U.S. Food and Drug Administration (FDA) from November 11-15, 2024. According to the announcement, the FDA issued an Establishment Inspection Report (EIR), confirming that the inspection is closed and Taizhou Xianju has passed the inspection. The inspection covered the production of raw materials, including rocuronium bromide, vecuronium bromide, prednisone, and hydrocortisone. The FDA indicated "No Action Indicated" (NAI). The successful inspection demonstrates that Taizhou Xianju's quality system meets FDA requirements. This will provide a solid guarantee for the company's continued expansion in the international market and enhance the international market competitiveness of the company's raw materials. The company cautioned that the international raw material pharmaceutical business is subject to market changes, industry policies, and supply and demand relationships.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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