延安必康(002411.SZ)：2批次地塞米松磷酸鈉注射液抽檢不合格
格隆匯10月29日丨延安必康(002411.SZ)公佈，近日，國家藥監局發佈的《國家藥監局關於83批次藥品不符合規定的通告》(2019年第75號)稱：經南京市食品藥品監督檢驗院檢驗，公司全資孫公司必康製藥新沂集團控股有限公司(“必康新沂”)生產的2批次地塞米松磷酸鈉注射液不符合規定，不符合規定項目分別為有關物質、可見異物。
該2批次產品批量較少，共計37.62萬支已全部銷售，實現銷售收入人民幣3.57萬元。必康新沂獲悉抽檢結果後，已及時通知經銷企業及使用單位停止以上2批次產品的銷售和使用，並及時啟動了問題批次產品的召回程序。截至10月29日，2批次產品均已銷售使用完畢，同時根據對2批次產品已使用地區的監測，未收到相關藥品的不良反應信息反饋。經必康新沂對2批次產品的留樣檢測及相鄰批次的留樣檢測，結果均為合格。
地塞米松磷酸鈉注射液是腎上腺皮質激素藥，由地塞米松磷酸鈉、亞硫酸氫鈉、丙二醇及適量的注射用水配製而成。根據該產品生產工藝特點，在生產過程中需進行充氮保護，因此必康新沂對2批次產品生產全過程從“人、機、料、法、環”全方位進行了細緻調查，確認2批次產品不合格原因是由於充氮機偶發故障，導致充氮不均，造成2批次產品在儲存期間出現“有關物質”不合格，同時2批次產品不合格系設備故障原因且不涉及其他批次。
必康新沂主要從事氨基酸注射液系列和小容量注射液的生產與銷售。截至10月29日，必康新沂註冊資本為3.48億元人民幣，系公司全資孫公司。
地塞米松磷酸鈉注射液2018年度、2019年上半年的銷售收入分別約為人民幣142.11萬元、人民幣4.62萬元，分別佔同期公司營業收入的0.017%、0.001%。問題批次產品所涉品種“地塞米松磷酸鈉注射液”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。
問題批次產品時間發生後，公司管理層高度重視，已要求必康新沂就產品生產過程進行全面複查並及時完成整改。公司將以此次事件為戒，嚴格按藥品生產質量管理規範要求，進一步加強藥品生產質量的全過程管理，排查可能造成藥品質量風險的隱患，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，從而確保產品質量，保證患者用藥的安全有效。截至目前，必康新沂已根據相關要求完成整改。
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