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華納藥廠(688799.SH):乙酰半胱氨酸獲得上市申請批准通知書
格隆匯 05-21 16:44

格隆匯5月21日丨華納藥廠(688799.SH)公佈,公司全資子公司湖南華納大藥廠手性藥物有限公司收到國家藥品監督管理局簽發的乙酰半胱氨酸《化學原料藥上市申請批准通知書》(通知書編號:2025YS00388),並在國家藥品監督管理局藥品審評中心(CDE)“原料藥、藥用輔料和藥包材登記信息公示”平台公示。

乙酰半胱氨酸是吸入用乙酰半胱氨酸溶液的原料藥。吸入用乙酰半胱氨酸溶液主要用於治療濃稠粘液分泌物過多的呼吸道疾病,如急性支氣管炎、慢性支氣管炎及其病情惡化者、肺氣腫、粘稠物阻塞症以及支氣管擴張症。

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