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復星醫藥(02196.HK):江蘇萬邦通過美國FDA現場檢查

格隆匯1月12日丨復星醫藥(02196.HK)發佈公吿,近日,公司控股子公司江蘇萬邦生化醫藥集團有限責任公司(以下簡稱“江蘇萬邦”)收到美國FDA(即美國食品藥品監督管理局)出具的現場檢查報吿(即EIR)。

本次為該注射劑生產線首次通過美國FDA現場檢查。截至該公吿日,江蘇萬邦該注射劑生產線所涉產品肝素鈉注射液已獲得美國FDA新增產線補充申請批准,江蘇萬邦已具備向美國市場供應該注射劑生產線所涉產品肝素鈉注射液的資格。

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