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華潤醫藥(03320.HK)附屬「賽洛多辛」化學原料藥上市申請獲批
阿思達克 09-19 12:21
華潤醫藥(03320.HK)公布,旗下雙鶴藥業(商丘)研發的賽洛多辛原料藥,近日獲國家藥監局批發《化學原料藥上市申請批准通知書》。 公司指,賽洛多辛主要用於治療良性前列腺增生症(BPH)引起的症狀和體征,在CDE原輔包登記信息平台上顯示狀態為「A」,預期是次獲批是表明該原料藥已符合國家相關藥品審評技術標準,待通過GMP符合性檢查後可生產銷售至內地市場,有利於進一步豐富公司的產品線,提升市場競爭力。
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