同仁堂(600085.SH)所屬製藥廠收到《藥品GMP檢查結果通知》
格隆匯6月3日丨同仁堂(600085.SH)公佈,公司所屬北京同仁堂股份有限公司同仁堂製藥廠(以下簡稱制藥廠)有關生產基地及生產車間經過現場檢查,符合《藥品生產質量管理規範(2010年修訂)》要求,收到北京市藥品監督管理局簽發的《藥品GMP檢查結果通知》。
此次認證生產線範圍為:丸劑(蜜丸)[丸劑二車間(蜜丸生產線107)];中藥前處理[粉碎車間(中藥前處理生產線)]、中藥提取[提取車間(中藥提取生產線)];中藥前處理[安國前處理(中藥前處理生產線)]。
各中藥前處理生產線為公司製藥過程中實施的蒸、炒、炙、煅、濃縮提取等炮製工序,屬於公司生產鏈條的中間程序,不形成產成品,亦無法與市場同類產品進行比較;各中藥前處理生產線本次現場檢查為按照藥監部門的規定與有關製劑生產線進行聯動認證。
丸劑生產線為公司新設立的生產線,本次藥品GMP現場檢查結果表明本公司有關生產線符合GMP要求,有助於公司完善產業鏈條,保證持續穩定的生產能力,更好的滿足市場需求,對公司未來發展產生積極作用,對當期業績無重大影響。
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