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九洲藥業(603456.SH):瑞博蘇州沙庫巴曲纈沙坦鈉原料藥及中間體通過日本GMP符合性檢查
格隆匯 10-11 16:07

格隆匯10月11日丨九洲藥業(603456.SH)公佈,近日,公司全資子公司瑞博(蘇州)製藥有限公司(“瑞博蘇州”)收到日本PMDA簽發的《醫藥品符合性調查結果通知書》,瑞博蘇州沙庫巴曲纈沙坦鈉原料藥及中間體通過日本GMP符合性檢查。

本次通過日本GMP審查的是公司沙庫巴曲纈沙坦鈉原料藥及中間體產線,終端產品沙庫巴曲纈沙坦鈉(諾欣妥)適用於治療射血分數降低的慢性心力衰竭(NYHAⅡ-Ⅳ級,LVEF≤40%)成人患者,降低心血管死亡和心力衰竭住院的風險。經查詢,沙庫巴曲纈沙坦鈉(諾欣妥)主要生產廠家為NovartisPharmaSchweizAG(諾華集團)。

根據諾華集團2020年年度報吿統計,2020年沙庫巴曲纈沙坦鈉(諾欣妥)全球銷售額為24.97億美元。

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