安成藥為第1家專注美國第4類(Paragraph IV)簡化新藥上市程序(Abbreviated New Drug Application, ANDA)及高技術門檻特殊學名藥的台灣藥廠,目前已有提出9項ANDA申請,其中有1項ANDA已獲得美國FDA的核准)以及1項獲得tentative approval(暫時性許可),預估產品在未來1-2年將陸續於美國市場上市銷售。
圖為安成藥董事長陳志明。資料照片
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