苑東生物(688513.SH):“重大疾病領域創新藥物系列產品產業化基地建設項目”取得階段性進展
格隆匯11月2日丨苑東生物(688513.SH)公佈,公司全資子公司成都碩德藥業有限公司(“碩德藥業”)正在建設的募投項目——“重大疾病領域創新藥物系列產品產業化基地建設項目”(“碩德藥業募投項目”)取得階段性進展,其新建生產車間的2條生產線經現場檢查符合相關法規要求,於近日收到四川省藥品監督管理局核發的《藥品生產許可證》。
公吿顯示,為進一步加快公司國際化戰略實施步伐,有效緩解公司固體制劑等的產能瓶頸,碩德藥業自 2018 年開始建設“重大疾病領域創新藥物系列產品產業化基地項目”。項目建設規劃用地面積131.6畝,計劃總投資6.2億,按照中國NMPA、美國FDA、歐洲EMA的標準設計,截止2021年9月底,項目已累計投資5.34億元,其中募集資金投資2.76億元。項目小容量注射劑(最終滅菌)、注射片劑生產線現已通過四川省藥品監督管理局的現場檢查,具備生產資格。
此次系全資子公司碩德藥業首次取得《藥品生產許可證》,標誌着碩德藥業募投項目取得關鍵階段性進展,並為公司國際化製劑產品獲得上市許可、進行商業化生產提供了生產保障。
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