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舒泰神(300204.SZ):通過藥品GMP符合性檢查,利於提高複方聚乙二醇(3350)電解質口服溶液的生產產能
格隆匯 04-13 17:49

格隆匯4月13日丨舒泰神(300204.SZ)公佈,公司於近日收到北京市藥品監督管理局頒發的《藥品GMP符合性檢查結果通知書》。

生產地址和生產範圍:北京市北京經濟技術開發區經海二路36號:片劑、硬膠囊劑、散劑、口服溶液劑、治療用生物製品***北京市大興區瑞合西一路67號(北京昭衍生物技術有限公司):治療用生物製品***南京市江北新區科創大道18號(南京海納製藥有限公司):口服乳劑***

檢查範圍:口服溶液劑(口服溶液車間、口服溶液劑生產線),品種為複方聚乙二醇(3350)電解質口服溶液(25ml/袋;國藥準字:H20223679)

檢查時間:2023年01月10日至01月13日、2023年03月24日至03月24日。

此次GMP現場檢查的順利通過有利於提高公司產品複方聚乙二醇(3350)電解質口服溶液的生產產能,也提升了產品的生產管理能力和質量管制體系,可以更好的滿足市場需求,持續保障公司經營。此次獲得《藥品GMP符合性檢查結果通知書》不會對公司業績產生重大影響。

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