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生物股份(600201.SH)子公司獲得《獸藥生產許可證》和《獸藥GMP證書》
格隆匯 02-18 16:43

格隆匯2月18日丨生物股份(600201.SH)公佈,公司全資子公司金宇保靈生物藥品有限公司(“金宇保靈”)於近日收到內蒙古自治區農牧廳核發的《獸藥生產許可證》和《獸藥 GMP 證書》。上述證書新增通過認證項目為金宇生物科技產業園區項目一期工程的口蹄疫細胞懸浮培養滅活疫苗生產線。

《獸藥生產許可證》:生產範圍:(1)鄂爾多斯西街:細菌活疫苗、細胞毒活疫苗、口蹄疫細胞懸浮培養滅活疫苗(3條)、豬瘟活疫苗生產線(兔源)(2)沙爾沁園區:細菌活疫苗、細菌滅活疫苗、細胞毒懸浮培養滅活疫苗、細胞毒活疫苗、口蹄疫細胞懸浮培養滅活疫苗。有效期:2016年7月5日至2021年7月4日。

《獸藥GMP證書》:驗收範圍:(1)鄂爾多斯西街:細菌活疫苗、細胞毒活疫苗、口蹄疫細胞懸浮培養滅活疫苗(3條)、豬瘟活疫苗生產線(兔源);(2)沙爾沁園區:細菌活疫苗、細菌滅活疫苗、細胞毒懸浮培養滅活疫苗、細胞毒活疫苗、口蹄疫細胞懸浮培養滅活疫苗。有效期:2016年7月5日至2021年7月4日

此次通過GMP認證的金宇生物科技產業園區項目一期工程的口蹄疫細胞懸浮培養滅活疫苗生產線,為新建生產線後進行的首次認證。

金宇生物科技產業園口蹄疫細胞懸浮培養滅活疫苗生產線通過認證並獲得GMP證書,標誌着上述生產線已滿足中華人民共和國農業農村部發布的《口蹄疫、高致病性禽流感疫苗生產企業設置規劃》等文件中關於生物安全三級防護的要求,實現了生產工藝流程智能化和產品全生命週期可追溯管控,有利於公司口蹄疫疫苗集約化生產,擴大現有產能,提升產品質量,滿足市場需求。

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