哈藥股份(600664.SH):哈藥總廠藥品注射用頭孢唑林鈉兩個規格通過仿製藥一致性評價
格隆匯12月31日丨哈藥股份(600664.SH)公佈,近日,公司分公司哈藥集團製藥總廠(“哈藥總廠”)收到國家藥品監督管理局頒發的關於注射用頭孢唑林鈉兩個規格的《藥品補充申請批准通知書》(編號:2021B04909和2021B04910),該兩個規格的藥品通過仿製藥質量和療效一致性評價。規格:0.5g、1.0g。
頭孢唑林為第1代頭孢菌素,抗菌譜主要為對頭孢唑林敏感的葡萄球菌、鏈球菌、肺炎鏈球菌、大腸桿菌、肺炎克雷伯菌、變形桿菌等菌屬。用於治療呼吸道感染、尿路感染、皮膚及軟組織感染、骨和關節感染、敗血症、感染性心內膜炎、肝膽系統感染、生殖系統感染、圍手術期預防感染。
中國化學制藥工業協會數據顯示,2020年注射用頭孢唑林鈉(摺合0.5g)全國總產量為22,198.16萬支,其中哈藥總廠產量為1529.27萬支,約佔全國總產量的6.89%。
截至公吿日,哈藥總廠針對該藥品仿製藥質量和療效一致性評價已投入研發費用約442萬元人民幣(未經審計)。
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