江蘇吳中(600200.SH):蘇藥廠生產的注射用硫酸阿米卡星抽檢不合格
格隆匯 7 月 3日丨江蘇吳中(600200.SH)公佈,2020年7月3日,公司所屬江蘇吳中醫藥集團有限公司蘇州製藥廠(“蘇藥廠”)收到《中國食品藥品檢定研究院檢驗報告》,蘇藥廠生產的注射用硫酸阿米卡星抽檢不合格。問題批次產品基本信息如下:
產品名稱:注射用硫酸阿米卡星;批號:1910094、1910124、1912044、1912054、1912064、1912074、1912094、1912104;規格:0.2g;檢驗項目:溶液的澄清度與顏色;生產單位:江蘇吳中醫藥集團有限公司蘇州製藥廠;檢驗結果:溶液濃於1號濁度標準液,淺於黃色3號標準比色液;不符合規定。
蘇藥廠已暫停生產並主動召回該藥品,可能產生的損失、賠償等情況暫不明確。問題批次產品事件發生後,公司管理層高度重視,立即啟動召回程序,發出召回通知。並要求蘇藥廠就產品生產過程進行全面複查並及時完成整改;同時也督促各成員企業以此次事件為戒,進一步加強藥品生產質量的全過程管理,持續提升產品全生命週期的質量風險管理水平,防止此類情況再次發生。
2019年度,蘇藥廠生產的注射用硫酸阿米卡星(0.2g)銷售收入887.13萬元,佔公司2019年度營業收入0.42%。問題批次產品所涉品種“注射用硫酸阿米卡星(0.2g)”的銷售收入佔公司整體營業收入比重較小,對公司的正常生產經營未造成實質性影響。
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