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國藥現代(600420.SH):全資子公司原料藥通過藥品GMP符合性檢查
格隆匯 02-07 16:37

格隆匯2月7日丨國藥現代(600420.SH)公佈,近日,公司全資子公司國藥集團工業有限公司(以下簡稱“國工有限”)收到河北省藥品監督管理局《藥品GMP符合性檢查結果通知單》。檢查範圍:原料藥(富馬酸喹硫平,原料藥車間富馬酸喹硫平生產線;咪達唑侖,原料藥車間咪達唑侖生產線)。

本次GMP符合性檢查為國藥集團工業有限公司廊坊分公司原料藥車間新增富馬酸喹硫平生產線及咪達唑侖生產線,合計設備投入約98.80萬元。涉及相關產品均已通過國家藥品監督管理局藥品審評中心技術審評,在原料藥、藥用輔料和藥包材登記信息公示平台上顯示登記號轉為“A”狀態。

富馬酸喹硫平是非典型抗精神病藥物之一,主要用於精神分裂症。該原料藥國內生產企業除國工有限外,還有湖南洞庭藥業股份有限公司、福安藥業集團重慶博聖製藥有限公司、浙江蘇泊爾製藥有限公司等。

咪達唑侖臨牀上用於治療失眠症,亦可用於外科手術或診斷檢查時作誘導睡眠用。該原料藥國內生產企業除國工有限外,還有江蘇恩華藥業股份有限公司、浙江九旭藥業有限公司、宜昌人福藥業有限責任公司。

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