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同仁堂(600085.SH)所屬製藥廠收到《藥品GMP檢查結果通知》
格隆匯 03-17 17:04

格隆匯3月17日丨同仁堂(600085.SH)公佈,公司獲悉,公司所屬北京同仁堂股份有限公司同仁堂製藥廠(製藥廠)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》。認證範圍:片劑、硬膠囊劑、顆粒劑、丸劑(蜜丸、水蜜丸、濃縮丸)、滴丸劑;中藥提取(集團內共用)、中藥前處理(集團內共用);中藥提取、中藥前處理;中藥前處理。

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此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。

此次藥品GMP現場檢查,是公司製藥廠原有《藥品GMP證書》到期的再認證。公司製藥廠收到《藥品GMP檢查結果通知》,檢查結果表明公司有關生產線符合GMP要求,有利於公司繼續保證產品質量和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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