健友股份(603707.SH):獲得美國肝素鈉注射液USP藥品註冊批件
格隆匯 7 月 16日丨健友股份(603707.SH)公佈,公司於近日收到美國食品藥品監督管理局(“美國FDA”)簽發的肝素鈉注射液USP ANDA批准通知(ANDA號:212061)。
公司於2020年7月15日獲得美國FDA的通知,公司向美國FDA申報的肝素鈉注射液USP(預充針)規格為5000 Units/mL,單劑量的ANDA申請獲得批準。
當前,美國境內,肝素鈉注射液USP的主要生產廠商有FRESENIUS KABI USA、PFIZER、SAGENT PHARM等。
截至目前,公司在肝素鈉注射液USP研發項目上已投入研發費用約人民幣2661.41萬元。
公司肝素鈉注射液USP(西林瓶)9個規格先前已全部獲得FDA批准並已在美國上市形成銷售,此次為預充針系列中的第二個規格獲批,新批准產品近期也將安排在美國上市銷售,有望對公司今年經營業績產生積極影響。
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