吉藥控股(300108.SZ)：控股孫公司克勝藥業被收回滴眼劑GMP證書
格隆匯3月24日丨吉藥控股(300108.SZ)公佈，公司於2020年3月23日收到控股孫公司江蘇普華克勝藥業有限公司(“克勝藥業”)被江蘇省藥品監督管理局責令收回滴眼劑GMP證書(證書編號：JS20160590)和收到江蘇省藥品監督管理局編號藥生告誡2019004《江蘇省藥品監督管理局告誡信》相關事宜的通知。
公司於2018年12月26日完成長春普華製藥股份有限公司(普華製藥)的收購，作為普華製藥的控股子公司克勝藥業於2019年4月11日完成工商變更登記，原克勝藥業的董事長、法定代表人為楊華。根據江蘇省藥監局的相關飛行檢查和《告誡信》註明被收回GMP證書的原因為：克勝藥業2017年採購原料羥苄唑違規、文件管理、計算機系統管理、部分原料供應商檔案、倉儲台賬、原料追溯、不良反應直報、原料羥苄唑檢驗(測定硫痠軟骨素鈉批號JC170901)等八項問題和缺陷嚴重違反藥品管理法、嚴重違反藥品GMP相關規定。克勝藥業於2019年12月9日被江蘇省局收回滴眼劑GMP證書。根據現場檢查結論如下：
1、要求克勝藥業滴眼劑在收回藥品GMP證書期間，不得生產；
2、要求克勝藥業加強管理，及時完善生產質量管理體系；
3、要求克勝藥業按照省局規定的期限進行整改和風險評估，並及時將整改報告和風險評估報告報省局和鹽城分局，鹽城分局屆時進行現場核實，並將核實情況上報省局；
4、克勝藥業要充分履行第一責任人職責，提高風險防控意識，確保藥品生產質量安全。
公司知悉相關事件後，與現任負責人詳細核查此事，對該事項高度重視，及時召開相關管理層會議，並要求克勝藥業全面梳理檢查中存在的問題，深刻反省造成管理缺陷的根源，查找漏洞，嚴格實施和遵守《中華人民共和國藥品管理法》的管理規定，增加對GMP要求的理解，進一步完善生產風險管理體系，並立即制定整改方案，儘快將整改情況上報藥品監督管理部門。
此次克勝藥業被收回《藥品GMP證書》，將造成該企業滴眼劑停產。2019年1-9月克勝藥業銷售收入為3529.95萬元，淨利潤為-57.82萬元，對公司年度業績影響較小，敬請投資者注意投資風險。
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.
