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博騰股份(300363.SZ):重慶長壽生產基地通過WHO GMP認證
格隆匯 12-07 20:45

格隆匯 12 月 7日丨博騰股份(300363.SZ)公佈,近日,公司收到WHO簽發的GMP(藥品生產質量管理規範)檢查結果通知,WHO對公司重慶長壽生產基地GMP體系提供的生產質量文件、記錄和報告進行了詳細書面檢查審核,得到滿意的結論,認定公司重慶長壽生產基地GMP體系符合WHO原料藥生產質量管理規範標準,此次GMP符合性認證有效期至2021年12月31日。

公司重慶長壽生產基地此次順利通過WHO的GMP認證,是繼其通過美國FDA(美國食品藥品監督管理局)、日本PMDA(日本獨立行政法人醫藥品醫療器械綜合機構)、歐盟EMA(歐盟藥品管理局)、中國NMPA(國家藥品監督管理局)等藥政當局GMP認證後又一次良好的認證記錄,是公司地瑞那韋原料藥(Darunavir API)可自主銷售至楊森授權的其他100多個指定國家和地區的又一重要里程碑,為公司進一步拓展海外市場奠定了基礎。鑑於公司地瑞那韋原料藥(Darunavir API)在相關國家和地區商業化銷售前還須取得WHO等相關機構的批准或資質,相關工作仍需要一定時間週期。公司後續將根據該事項的進展情況及時履行信息披露義務。

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