康寧傑瑞製藥-B(09966.HK)完成I期生產基地建設
格隆匯12月17日丨康寧傑瑞製藥-B(09966.HK)公告,公司新生產基地I期建設已於2019年12月完成。I期生產基地位於中國江蘇省蘇州市蘇州工業園區方洲路175號,產能為4,000L(2x2,000L)。I期生產基地目前正在調試和驗證中,並即將開始生產試運行。
公司正在蘇州建造自有的製造及研發設施,旨在符合國家藥品監督管理局及歐盟╱美國食品藥品監督管理局現行藥品優良製造規範的規定,預期產能超過30,000L。新基地I期的商業產能為4,000L(2x2,000L),規劃建築面積為53,867平方米。新生產基地由全面的內部質量管理系統提供支持。本公司已為其大規模生產配備先進的技術平台、CMC流程及技術知識。
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