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衞信康(603676.SH):獲門冬氨酸鉀鎂注射液藥品註冊批件
格隆匯 01-03 16:22

格隆匯1月3日丨衞信康(603676.SH)公佈,公司)全資子公司內蒙古白醫製藥股份有限公司近日收到國家藥品監督管理局核准簽發的門冬氨酸鉀鎂注射液《藥品註冊批件》。

門冬氨酸鉀鎂注射液為電解質補充藥,可用於低鉀血癥,洋地黃中毒引起的心律失常(主要是室性心律失常)以及心肌炎後遺症、充血性心力衰竭、心肌梗塞的輔助治療。已被納入2019版國家醫保藥品目錄(乙類)。公司的產品是參考日本田邊三菱製藥株式會社的門冬氨酸鉀鎂注射液工藝,採用國家批准的合法原料藥門冬氨酸鉀及門冬氨酸鎂製備而成。

經查詢,國內已批准的門冬氨酸鉀鎂注射劑有門冬氨酸鉀鎂注射液、注射用門冬氨酸鉀鎂(凍乾粉針劑),生產廠商包括瑞陽製藥有限公司、匈牙利吉瑞大藥廠等51家。根據米內網數據統計,2018年門冬氨酸鉀鎂注射劑在我國城市、縣級、社區及鄉鎮三大終端公立醫療機構的銷售額約為5.51億元。

截至2019年12月31日,門冬氨酸鉀鎂注射液項目已投入研發費用約574.45萬元人民幣。

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