中國醫藥(600056.SH)：子公司兩批次注射用奧扎格雷鈉的[可見異物]項目均不符合規定 收到行政處罰決定書
格隆匯12月31日丨中國醫藥(600056.SH)公佈，近日，公司下屬子公司海南通用康力製藥有限公司(“通用康力”)收到海南省藥品監督管理局下發的《行政處罰決定書》(瓊藥監罰[2021]36號)。
海南省藥品檢驗所對通用康力生產的兩批次注射用奧扎格雷鈉(批號:21911021、21911022)進行抽樣，經上海市食品藥品檢驗所檢驗，兩批次藥品的[可見異物]項目均不符合規定。屬於《中華人民共和國藥品管理法》第九十八條第三款第七項所規定的藥品。
鑑於通用康力屬於初次違法，在收到藥品不合格檢驗報吿後積極主動召回藥品24804瓶，儘可能的消除和減輕違法行為造成的危害後果。調查過程中，通用康力積極配合調查，如實交代並提供相關證據材料。依據《海南省藥品監督管理局行使行政處罰裁量權適用規則》第十條第(二)項、第十一條第(一)、(三)項，具有從輕或減輕處罰情形。
依據《海南省藥品監督管理局行使行政處罰裁量權適用規則》第十五條規定，通用康力的行為為一般(較輕)裁量階次。依據《中華人民共和國藥品管理法》第一百一十七條第一款規定，決定處罰如下：1.沒收涉案注射用奧扎格雷鈉24744瓶(其中21911021批次11168瓶，21911022批次13576瓶)；2.沒收違法所得23.66萬元；3.處貨值金額14倍罰款433.47萬元。上述罰沒款合計457.13萬元。
事件發生後，公司高度重視，通用康力及時採取相關控制措施，立即主動召回了相關藥品，並收集不良反應報吿，截止目前，通用康力未收到相關批次產品的嚴重不良反應報吿的反饋。公司將引以為戒，吸取教訓，並持續加強對下屬子公司的管控和監督，在今後的生產經營中嚴格按照相關法律法規的要求加強藥品生產質量的全過程管理，確保患者用藥安全，更好地履行社會責任。目前，通用康力生產經營情況正常。
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.
