聯環藥業(600513.SH):相關原料藥通過GMP符合性檢查
格隆匯5月11日丨聯環藥業(600513.SH)公佈,近日,江蘇聯環藥業股份有限公司從江蘇省藥品監督管理局網站獲悉藥品GMP符合性檢查結果公吿(2022年第40號)。
檢查範圍:原料藥硫酸黏菌素(在二車間C7和C8廠房生產,一般區為專用生產線,其中菌種傳代工序在C8廠房三層D級潔淨區生產,菌種培養、發酵、提取工序在C8廠房一層至三層生產,粗品製備工序在C7廠房四層生產,精製工序在7號C7廠房三層14號精烘包生產)、特非那定(在一車間C1和C3廠房生產,其中酯化、縮合、還原、格氏加成工序在C1廠房一層至四層生產,氫化工序在C3廠房南側二層生產,脱色精製工序在C1廠房五層生產,精製工序在1號精烘包生產)、巴洛沙星(在一車間C1和C2廠房生產,其中整合、取代、水解、一精工序在C2廠房一層至四層生產,精製工序在C1廠房五層2號精烘包生產)。
具體情況如下:

公司此次原料藥GMP符合性檢查是生產場地變更後恢復性生產所增加的品種認證,原料藥硫酸黏菌素生產線(部分工序與其他品種共線)總投入約為人民幣580萬元,原料藥特非那定生產線總投入約為人民幣1198萬元,原料藥巴洛沙星生產線(部分工序與其他品種共線)總投入約為人民幣1015萬元(以上未經審計)。
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