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普洛藥業(000739.SZ)子公司獲得獸藥生產許可證和獸藥GMP證書
格隆匯 08-19 16:41

格隆匯8月19日丨普洛藥業(000739.SZ)公佈,近日,公司全資子公司浙江普洛康裕製藥有限公司收到了浙江省農業農村廳頒發的KY-FBZ和馬波沙星原料藥的《獸藥生產許可證》和《獸藥GMP證書》。

《獸藥生產許可證》生產範圍:非無菌原料藥(KY-FBZ、馬波沙星);有效期至:2019年8月5日至2024年8月4日。

《獸藥GMP證書》驗收範圍:非無菌原料藥(KY-FBZ、馬波沙星);有效期至:2019年8月5日至2024年8月4日。

此前,公司馬波沙星原料藥已通過歐盟COS認證;KY-FBZ原料藥為公司CDMO項目。此次為公司以上兩個產品生產線在國內首次GMP認證通過,其中,馬波沙星原料藥之前主要銷往海外市場。按照《獸藥管理條例》、《獸藥產品批准文號管理辦法》等相關規定,獸藥原料藥在國內市場銷售前尚需取得獸藥產品批准文號,公司將積極開展相關注冊工作,進一步拓展和完善公司獸藥業務領域。

通過此次認證,公司在獸藥原料藥的 GMP規範和產品認證方面有了進一步的經驗積累,對進一步拓展獸藥領域相關其他產品具有一定積極作用。

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