福元醫藥(601089.SH):磷酸特地唑胺片獲得藥品註冊證書及原料藥通過CDE技術審評
格隆匯1月9日丨福元醫藥(601089.SH)公佈,近日,北京福元醫藥股份有限公司收到了國家藥品監督管理局頒發的磷酸特地唑胺片(規格:200mg)(簡稱“該藥品”)《藥品註冊證書》(證書編號:2022S01229),批准該藥品生產。同時原料藥磷酸特地唑胺也獲國家藥監局關聯審評通過,已批准在上市制劑中使用。
該藥品是一種噁唑烷酮類抗菌藥,用於治療急性細菌性皮膚及皮膚軟組織感染。截至公吿日,公司針對該藥品累計研發投入為人民幣2004.14萬元(含磷酸特地唑胺原料藥和磷酸特地唑胺片研發費用,未經審計)。
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