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海普瑞(002399.SZ):新建制劑生產線獲得GMP證書
格隆匯 02-14 16:50

格隆匯2月14日丨海普瑞(002399.SZ)公佈,公司近日收到波蘭衞生監督機構(Chief Pharmaceutical Inspector)頒發的《Certificate of GMP Compliance of a Manufacturer》(簡稱“GMP證書”),該證書已在歐洲藥品管理局(EMA)網站公示。

海普瑞坪山園區新建預灌封製劑生產線項目於2022年正式啟動,首期新建三條預灌封生產線設計產能為3.3億支/年,按照中國、歐美藥品法規標準設計建造,用於生產依諾肝素鈉預灌封注射液。2024年該項目完成建設並首次通過歐盟GMP認證。根據歐盟成員國之間的GMP互認制度,本次通過GMP認證表明本次接受認證的生產線已符合歐盟GMP標準。

歐洲是海普瑞全球製劑業務的重要市場,近年來,公司旗下依諾肝素鈉製劑市場份額穩居歐洲前二,新建制劑生產線獲得GMP證書將為公司進一步推進製劑國際化戰略提供更加充足的產能保障,切實提高公司市場競爭力。

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