ST諾泰(688076.SH):司美格魯肽、利拉魯肽原料藥生產線通過巴西衛生監督局cGMP現場檢查
格隆匯8月5日丨ST諾泰(688076.SH)公佈,近日收到PIC/S成員巴西國家衛生監督局(ANVISA)簽發的《藥品生產質量管理規範證書》CBPF-GMP證書。本次檢查覆蓋公司連雲港工廠cGMP系統,產品包括原料藥司美格魯肽及利拉魯肽。PIC/S(PharmaceuticalInspectionCo-operationScheme)是一個旨在促進藥品生產質量全球統一標準的國際組織,成員遍佈歐洲、美洲、亞洲、大洋洲等地區。
公司本次司美格魯肽、利拉魯肽原料藥生產線通過巴西衛生監督局cGMP現場檢查,是繼美國食品藥品監督管理局(FDA)、韓國食品藥品安全部(MFDS)後通過的又一海外官方合規檢查。標誌着公司擁有符合國際法規市場標準的生產質量管理體系,將進一步推進公司產品在海外市場的銷售和推廣。
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