復宏漢霖(02696.HK)上海生產基地獲歐盟GMP證書
復宏漢霖-B(02696.HK)公布,近日,全資子公司上海復宏漢霖收到波蘭衛生監督機構Chief Pharmaceutical Inspector頒發的兩項GMP證書,分別為原液線(DS)與制劑線(DP)的認證。標誌公司位於上海市徐匯區的生物藥生產基地順利通過歐盟針對HLX02(注射用曲妥珠單抗)的原液(DS)及制劑(DP)的GMP核查,已符合歐盟GMP標準。
獲得GMP證書後,HLX02(注射用曲妥珠單抗)尚需獲得歐盟營銷授權申請(MAA)批准後方可於歐盟上市。
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