復宏漢霖(02696.HK)鬆江基地通過藥品GMP符合性檢查
復宏漢霖(02696.HK)公佈,全資子公司上海復宏漢霖生物醫藥近日收到上海市藥品監督管理局簽發的《藥品生產現場檢查結果告知書》,集團位於上海市鬆江區的生物藥生產基地中,用於生產產品「漢曲優(R)」的原液生產西線和東線、製劑(DP)生產線及包裝線,已通過上海市藥品監督管理局組織開展的藥品生產質量管理規範符合性檢查(藥品GMP符合性檢查)。
公司表示,是次通過檢查,標誌着其已具備符合中國GMP法規要求的質量管理體系,待漢曲優生產工藝及生產場地變更等的補充申請(sNDA)獲NMPA批準後,鬆江基地方可開展漢曲優中國境內的商業化生產。
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