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仙琚製藥(002332.SZ)獲得《藥品GMP證書》
格隆匯 12-13 11:56

格隆匯12月13日丨仙琚製藥(002332.SZ)公佈,公司於近日收到浙江省藥品監督管理局核准簽發的中華人民共和國《藥品GMP證書》。認證範圍包括原料藥(十一酸睾酮、丙酸睾酮、雌二醇、苯甲酸雌二醇、鹽酸羅哌卡因、甲磺酸羅哌卡因);片劑(激素類)、小容量注射劑(激素類)。

此次獲得的《藥品GMP證書》所涉及公司6只原料藥品種,系在公司位於浙江省台州市仙居縣福應街道現代工業集聚區豐溪西路15號的原料藥新廠區生產線首次認證取得,表明上述原料藥產品生產線符合中華人民共和國《藥品生產質量管理規範》要求。公司上述品種轉移到原料藥新廠區生產有利於公司生產和質量管理體系的提升,為公司原料藥發展奠定堅實基礎。

此次獲得的《藥品GMP證書》所涉及的小容量注射劑(激素類)生產線為到期再認證,片劑(激素類)生產線為新增生產線首次認證,該片劑(激素類)生產線通過認證後可豐富片劑的種類及產能。

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