西藏藥業(600211.SH)子公司成都諾迪康通過藥品GMP現場檢查
格隆匯2月14日丨西藏藥業(600211.SH)公佈,2020年2月13日,公司全資子公司成都諾迪康生物製藥有限公司(“成都諾迪康”)收到四川省藥品監督管理局頒發的《藥品GMP現場檢查結果通知書》(編號:川2020027),檢查範圍:治療用生物製品(注射用重組人腦利鈉肽),檢查車間:基因車間A線、凍幹車間,檢查時間:2019年11月16日至2019年11月19日,檢查結論:根據此次檢查情況,經審查,該企業符合《藥品生產質量管理規範(2010年修訂)》和附錄要求。
此次檢查車間2個:基因車間A線、凍幹車間。上述基因車間A線、凍幹車間主要承擔公司產品新活素的生產任務。新活素系我公司的主要產品,此次檢查的生產線屬於新活素原有生產線。近年來,由於新活素銷量大幅提升,為了滿足市場需求,公司已完成了新生產線的擴建工作,新生產線目前處於註冊核查階段。
新活素作為治療急性心衰的基因工程藥物,能快速改善心衰患者的心衰症狀和體徵,提高患者的生存質量;我公司生產的新活素系國內獨家品種,填補了國內治療急性心衰的基因工程藥物的空白。
此次成都諾迪康獲得上述《藥品GMP現場檢查結果通知書》,表明成都諾迪康相關生產線符合GMP要求,有利於公司繼續保證產品質量和持續穩定的生產能力,更好的滿足市場需求,對公司未來發展產生積極作用,對當期業績無重大影響。
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