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博瑞醫藥(688166.SH):信泰製藥獲三張藥品GMP證書
格隆匯 12-18 17:31

格隆匯12月18日丨博瑞醫藥(688166.SH)公佈,公司子公司信泰製藥(蘇州)有限公司(下稱“信泰製藥”)於近日收到三張江蘇省藥品監督管理局簽發的中華人民共和國《藥品GMP證書》。

本次獲得的《藥品GMP證書》,涉及小容量注射劑(預灌封注射器)、凍乾粉針劑生產線,表明上述製劑產品生產線符合中華人民共和國《藥品生產質量管理規範》要求,標誌着信泰製藥位於蘇州工業園區星湖街218號C25樓、C26樓、C28樓的生產基地可以正式生產和銷售磺達肝癸鈉注射液和注射用艾司奧美拉唑鈉。

本次獲得的《藥品GMP證書》,涉及片劑生產線,表明上述製劑產品生產線符合中華人民共和國《藥品生產質量管理規範》要求,標誌着信泰製藥位於蘇州工業園區星湖街218號C25樓、C26樓、C28樓的生產基地可以正式生產和銷售恩替卡韋片。

本次獲得的《藥品GMP證書》,涉及公司原料藥產品米卡芬淨鈉,表明上述原料藥產品生產線符合中華人民共和國《藥品生產質量管理規範》要求。

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