華海藥業(600521.SH):公司收到FDA警告信
格隆匯6月9日丨華海藥業(600521.SH)公佈,公司於近日收到美國食品藥品監督管理局(以下簡稱“FDA”)發出的警告信,該警告信系基於2025年1月16日至1月24日期間FDA對公司位於臨海市汛橋鎮的藥品生產基地(以下簡稱“汛橋生產基地”)進行的現場檢查。警告信針對汛橋生產基地的製劑產品提出了相關檢查意見和改進建議,主要涉及部分口服固體生產設備清潔管理、無菌生產區域維護和壓片剔廢參數研究的充分性。
公司高度重視FDA的建議,已積極採取措施進行優化,並持續與FDA保持積極溝通。公司將持續提升質量管理體系,確保合規運營。
公司製劑生產基地主要有汛橋製劑生產基地(位於浙江省臨海市汛橋鎮)和子公司浙江華海製藥科技有限公司(位於臨海市江南街道)。本次警告信僅對涉及汛橋生產基地的ANDA新申請或補充申請的批準產生影響,不會對公司當期業績產生重大影響。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.