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立方製藥(003020.SZ):“鹽酸哌甲酯”原料藥註冊申請通過CDE審批
格隆匯 07-29 17:01

格隆匯7月29日丨立方製藥(003020.SZ)宣佈,近日,公司在國家藥監局藥品審評中心(CDE)“原料藥、藥用輔料和藥包材登記信息公示”平台查詢獲悉,公司提交的“鹽酸哌甲酯”原料藥註冊申請通過了CDE審批。

鹽酸哌甲酯為苯丙胺類中樞精神興奮劑,屬於第一類精神藥品,其製劑用於治療6歲以上兒童注意缺陷多動障礙(Attention Deficit Hyperactivity Disorder,ADHD)。

截至該公吿日,國產和進口藥品均有鹽酸哌甲酯製劑批准文號,在國家藥監局平台未查詢到鹽酸哌甲酯原料藥國產批准文號和進口批准文號,在“原料藥、藥用輔料和藥包材登記信息公示”平台也未查到其他與製劑共同審評審批結果為“A”的鹽酸哌甲酯原料藥。

公司鹽酸哌甲酯原料藥通過CDE審批,表明該原料藥符合中國相關藥品審評技術標準,已批准在國內上市制劑中使用,有利於公司拓展產品銷售。

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