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海利生物(603718.SH):控股子公司通過生物安全三級防護標準驗收並獲得《獸藥生產許可證》、《獸藥GMP證書》
格隆匯 11-23 16:44

格隆匯 11 月 23日丨海利生物(603718.SH)公佈,公司控股子公司楊凌金海生物技術有限公司(“楊凌金海”)於近日通過獸用疫苗生產企業生物安全三級防護標準驗收和獸藥GMP(2020年修訂)驗收,並獲得陝西省農業農村廳頒發的《獸藥生產許可證》、《獸藥GMP證書》和楊凌金海符合《獸用疫苗生產企業生物安全三級防護標準》相關規定説明文件。

《獸藥生產許可證》:證號:(2020)獸藥生產證字27048號;企業名稱:楊凌金海生物技術有限公司;註冊地址:陝西省楊淩示範區東環北路31號;生產範圍:口蹄疫細胞懸浮培養滅活疫苗;生產地址:陝西省楊淩示範區東環北路31號;有效期:2020年11月19日至2025年11月18日

《獸藥GMP證書》:證號:(2020)獸藥GMP證字27005號;企業名稱:楊凌金海生物技術有限公司;生產地址:陝西省楊淩示範區東環北路31號;驗收範圍:口蹄疫細胞懸浮培養滅活疫苗;有效期:2020年11月19日至2025年11月18日

楊凌金海現有口蹄疫細胞懸浮培養滅活疫苗生產車間、檢驗動物房等生產、檢驗車間及配套公共設施,設計產能4億頭份口蹄疫疫苗,此次獸藥GMP驗收是在原基礎上的複驗,並對生產車間和檢驗動物房進行升級改造,使之符合《獸藥生產質量管理規範》(2020年修訂)和《獸用疫苗生產企業生物安全三級防護標準》(農業部公告第2573號)的有關標準要求,相關改造累計投入近2300萬元。

楊凌金海作為公司控股子公司,此次獲得《獸藥生產許可證》《獸藥GMP證書》和符合《獸用疫苗生產企業生物安全三級防護標準》相關規定説明文件,有效地説明了楊凌金海已滿足《獸藥生產質量管理規範》(2020年修訂)、《口蹄疫、高致病性禽流感疫苗生產企業設置規劃》(農醫發【2016】37號)和《獸用疫苗生產企業生物安全三級防護標準》(農業部公告第2573號)的相關規定和要求,並且通過技術改造使得相關產品生產達到更高的質量標準和安全標準,也提高了生產效率,有利於公司繼續保持穩定的生產能力,滿足市場需求。

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