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  •     華益藥業科技(安徽)有限公司是安徽省首家通過歐盟認證,專注于為中國和歐盟市場提供片劑/膠囊CMO服務的企業。公司于2010年8月通過英國藥品和保健品監督管理局(MHRA)的審計并獲頒歐盟GMP證書,已先后三次通過歐盟官方審計,并已通過Teva、KrKa、Novartis等跨國公司的質量審計。

        高水平的質量管理是公司賴以生存和發展的基礎。自成立之日起,公司就嚴格按照歐盟GMP的要求進行建設和管理,建立了高標準的質量體系,將歐盟GMP的理念貫穿到了建設、研發、生產、檢驗、物流等各環節。并本著持續改進的理念,始終緊跟歐盟GMP法規的現行要求,不斷優化和提升,確保質量合規、確保持續穩定生產出符合要求的產品。






        華益可承接片劑、膠囊劑、口服液體制劑的委托研發(包括中歐雙報)、臨床批生產、商業化代工。自成立至今,已完成超過50個產品的研發和轉移,為客戶在歐盟成功注冊10余個產品的藥證,均實現商業化代工生產。公司現有產能30億片,可擴至50億片,2018年生產量達16億片。同時正在建設普通激素、口服液體制劑車間,并規劃建設性激素、抗癌制劑車間。

        華益的目標是為客戶提供從藥品研發到商業化生產的一站式服務,堅持“以責任打造品質,以品質謀求共贏”的企業價值觀,為客戶實現高效、高質、成本可控的仿制藥研發和生產服務,為百姓用得起好藥盡綿薄之力。

        發展中的華益熱忱期待與國內外伙伴在仿制藥研發、臨床批生產、商業化代工、中歐雙報等領域建立形式多樣的合作關系,共同開拓國際和國內醫藥市場。



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