白雲山(00874.HK)子公司通過澳大利亞TGA-GMP認證
格隆匯5月17日丨白雲山(00874.HK)發佈公吿,近日,公司全資子公司廣州白雲山中一藥業有限公司(以下簡稱“中一藥業”)收到澳大利亞藥物管理局(TGA)頒發的GMP證書,TGA是TherapeuticGoods Administration 的簡寫,全稱是澳大利亞藥物管理局。
中一藥業本次TGA-GMP認證生產線3條,為製造一部、製造二部、製造三部丸劑生產線和片劑生產線,以及製造四部中藥前處理生產線。本次認證累計投入費用約人民幣31萬元(未經審計)。
澳大利亞對藥物的生產和進口實施嚴格的管理,是世界上藥品管理嚴格、市場準入難度較高的國家之一。本次中一藥業通過TGA的GMP認證,表明其在質量體系和生產環境設施等方面得到TGA的認可。澳大利亞是國際藥品認證合作組織(PIC/S)的成員國,這將對公司在國際市場的開發起到積極的推動作用。
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