我武生物(300357.SZ):公司藥品生產許可證增加生產範圍
格隆匯5月20日丨我武生物(300357.SZ)公佈,公司於近日收到浙江省藥品監督管理局的准予行政許可決定書,同意公司《藥品生產許可證》增加生產範圍。
同意在地址浙江省德清縣武康鎮志遠北路636號新增生產範圍:體內診斷試劑(黃花蒿花粉點刺液、白樺花粉點刺液、葎草花粉點刺液、豚草花粉點刺液、懸鈴木花粉點刺液、狗毛皮屑點刺液、貓毛皮屑點刺液、德國小蠊點刺液)(941原料處理車間、921點刺原液車間、133點刺成品車間及相應生產線)、體內診斷試劑(變應原皮膚點刺試驗對照液)(133點刺成品車間變應原皮膚點刺試驗對照液生產線)。相關事項載明在公司《藥品生產許可證》(副本)變更記錄頁中。
此次《藥品生產許可證》增加生產範圍有利於公司在過敏原體內診斷領域產品線的佈局,以更好滿足市場需求。
此次增加生產範圍的8項變應原皮膚點刺產品(黃花蒿花粉點刺液、白樺花粉點刺液、葎草花粉點刺液、豚草花粉點刺液、懸鈴木花粉點刺液、狗毛皮屑點刺液、貓毛皮屑點刺液、德國小蠊點刺液)以及變應原皮膚點刺試驗對照液,均處在III期臨牀試驗階段,上述點刺產品均屬於生物製品類體內診斷試劑,適應症為:用於點刺試驗,輔助診斷I型變態反應性疾病。截至公吿披露日,經查詢國家藥品監督管理局官網,尚無其他企業取得上述變應原皮膚點刺產品的藥品註冊證書。
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