京新藥業(002020.SZ):通過德國GMP認證
格隆匯 12 月 17日丨京新藥業(002020.SZ)公佈,近日,公司通過EudraGMDP(歐盟檢查數據庫)查詢,公司已於2020年12月14日獲得德國官方GMP認證機構頒發的證書號“DE_BW_01_GMP_2020_0159”的生產商GMP符合性證書,證書有效期3年,標誌着公司第六次通過德國(歐盟)GMP認證。
2020年11月25日,德國官方GMP認證機構根據(EC)726/2004法規等規定對公司綜合固體制劑生產車間進行了遠程視頻審計檢查,確認公司非無菌產品:膠囊劑、片劑通過德國GMP認證。
此次通過德國GMP認證的綜合固體制劑生產車間包括公司2014 年度募集資金投資項目“浙江京新藥業股份有限公司年產20億粒固體制劑擴產項目”的製劑生產車間,該車間已於今年3月通過國內GMP符合性檢查。
公司再次獲得德國GMP認證證書,標誌着公司現有綜合固體制劑車間膠囊劑、片劑生產線整體通過德國(歐盟)GMP認證,將進一步擴大公司外貿產品的生產銷售,推動公司製劑外貿業務的增長。
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