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人福醫藥(600079.SH):宜昌人福對乙酰氨基酚注射液申報生產獲受理
格隆匯 04-15 19:48

格隆匯4月15日丨人福醫藥(600079.SH)公佈,公司控股子公司宜昌人福藥業有限責任公司(簡稱“宜昌人福”,公司持有其80%的股權)近日收到國家藥品監督管理局核准簽發的對乙酰氨基酚注射液申報生產的《受理通知書》。

國內已獲批的對乙酰氨基酚相關製劑主要為口服和肌肉注射液。該次獲得受理的對乙酰氨基酚注射液可靜脈給藥,適用於治療輕度至中度疼痛,或與阿片類藥物聯用治療中度至重度疼痛,以及解熱。目前已上市的同類產品為江蘇恆瑞醫藥股份有限公司的對乙酰氨基酚甘露醇注射液,公司未從公開渠道獲知其市場銷售數據。截至目前,宜昌人福該項目累計投入約為3400萬元人民幣。

對乙酰氨基酚注射液申報生產被國家藥品監督管理局受理,標誌着該品種境內生產藥品註冊工作進入了審評階段,公司將積極推進後續相關工作,如順利通過審評審批,將豐富公司的產品線,有利於提升公司的市場競爭力。

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