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中國同輻(01763.HK):治療用碘[131I]化鈉膠囊等品線通過藥品GMP符合性檢查
格隆匯 09-14 17:56

格隆匯9月14日丨中國同輻(01763.HK)發佈公吿,近日,原子高科(以下簡稱“公司”)體內放射性藥品[(膠囊劑、治療用碘[131I]化鈉膠囊)(體內放射性藥品生產車間);(小容量注射劑、氟[18F]脱氧葡糖注射液)(氟[18F]標記藥物生產車間)]通過北京市藥品監督管理局藥品GMP符合性檢查,本次檢查結果符合《藥品生產質量管理規範(2010年修訂)》標準。

本次檢查是治療用碘[131I]化鈉膠囊品種取得註冊文號後首次通過藥品GMP符合性檢查,標誌着公司治療用碘[131I]化鈉膠囊具備了投產上市能力,將為國內臨牀甲癌及甲亢的治療提供一種新選擇。治療用碘[131I]化鈉膠囊在臨牀應用上的不斷推廣,將有利於提高甲癌及甲亢患者的生活質量。同時,治療用碘[131I]化鈉膠囊可直接到達患者胃部,避免了放射性碘[131I]易粘附在患者口腔、鼻腔、食道等部位而引起的副作用和揮發性放射性污染,對醫院的放射性污染水平和輻射防護條件將有明顯改善。公司下一步將加大市場推廣力度,力爭早日實現社會效益與經濟效益雙豐收。

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