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普利製藥(300630.SZ):安徽普利通過美國FDA現場審計
格隆匯 11-23 18:56

格隆匯11月23日丨普利製藥(300630.SZ)公佈,公司的全資子公司安徽普利藥業有限公司(簡稱“安徽普利”)於2023年8月21日至2023年8月25日接受了美國食品藥品監督管理局(簡稱“美國FDA”)的cGMP(即現行藥品生產質量管理規範)現場檢查。近日,公司收到了美國FDA簽發的現場檢查報吿(EIR)。

釓特酸葡胺是一種新型的離子型大環類結構的釓類化合物,用於磁共振成像(MRI)的靜脈注射造影劑。

環磷酰胺(CTX)作為常用的抗腫瘤藥物,在各種腫瘤中廣泛應用,比如常用於惡性淋巴瘤、急性或慢性淋巴細胞白血病、多發性骨髓瘤。對乳腺癌、睾丸腫瘤、卵巢癌、肺癌、頭頸部鱗癌、鼻咽癌、神經母細胞瘤、橫紋肌肉瘤及骨肉瘤均有一定的療效。目前也常用於風濕性疾病和腎臟疾病。

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