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諾泰生物(688076.SH):新建口服固體制劑車間幹混懸劑及顆粒劑生產線通過藥品GMP符合性檢查
格隆匯 01-20 16:43

格隆匯1月20日丨諾泰生物(688076.SH)公佈,公司中華藥港廠區203車間按照FDA/EMA標準設計,引進Glatt濕法制粒線、KILIAN雙出料壓片機、SYNTEGON膠囊填充機、Glatt包衣機、CAM自動化包裝線等國際一線品牌設備,設計年產能:片劑&硬膠囊劑45億片/粒、口服幹混懸劑&顆粒劑(瓶裝)3600萬瓶、顆粒劑(袋裝)/散劑4.5億袋,該車間已完成竣工驗收。其中,該車間的幹混懸劑生產線及顆粒劑生產線於近日收到江蘇省藥品監督管理局簽發的《藥品GMP符合性檢查吿知書》(蘇藥監藥生吿知[2025]037號、[2025]038號),通過藥品GMP符合性檢查。

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