羅欣藥業(002793.SZ):取得克林黴素磷酸酯注射液上市申請受理通知書
格隆匯 7 月 2日丨羅欣藥業(002793.SZ)公佈,近日,公司下屬子公司山東羅欣藥業集團股份有限公司(“山東羅欣”)收到國家藥品監督管理局下發的克林黴素磷酸酯注射液上市申請《受理通知書》。
克林黴素磷酸酯為克林黴素2位羥基磷脂化的衍生物,注射後在體內經鹼性水解酶水解,形成克林黴素而發揮抗菌活性。克林黴素通過抑制細菌蛋白質的合成而發揮抗菌效能,對大多數革蘭陽性菌和某些厭氧的革蘭陰性菌都有抗菌作用。
根據我國藥品註冊相關的法律法規要求,克林黴素磷酸酯注射液經國家藥品監督管理局藥品審評中心審評、審批通過後方可上市銷售。
根據Insight數據,截至公告披露日,克林黴素磷酸酯注射液國內暫無通過仿製藥一致性評價的生產廠家。山東羅欣此次就克林黴素磷酸酯注射液以化學藥品第3類仿製藥遞交上市申請,申請獲批後可直接上市銷售,視同通過仿製藥一致性評價,屆時將進一步豐富山東羅欣產品線,提升市場競爭力。
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