普萊柯(603566.SH):南京子公司獲得三個獸藥產品批准文號
格隆匯12月16日丨普萊柯(603566.SH)公佈,根據《獸藥管理條例》和《獸藥產品批准文號管理辦法》的規定,經農業農村部審查,准予公司全資子公司普萊柯(南京)生物技術有限公司(以下簡稱“普萊柯南京公司”)生產高致病性禽流感相關產品,並核發獸藥產品批准文號。
產品名稱為“重組禽流感病毒(H5+H7)三價滅活疫苗(H5N1Re-11株+Re-12株,H7N9H7-Re3株)“、“重組禽流感病毒滅活疫苗(H5N1亞型,Re-5株)”、”重組禽流感病毒滅活疫苗(H5N1亞型,Re-6株)“。
按照《口蹄疫、高致病性禽流感疫苗生產企業設置規劃》相關規定,上述三個產品批准文號是在普萊柯南京公司生產線通過生物安全三級防護標準驗收,並取得江蘇省農業農村廳發放的《獸藥生產許可證》、《獸藥GMP證書》等資質文件的基礎上,履行產品批准文號更換程序所取得的產品批准文號。
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