健友股份(603707.SH):獲得美國鹽酸吉西他濱注射液藥品註冊批件
格隆匯 12 月 14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”)簽發的鹽酸吉西他濱注射液,200mg/5.26mL,1g/26.3mL,2g/52.6mL的ANDA批准通知(ANDA號:212129)。
公司於2020年12月12日獲得美國FDA的通知,公司向美國FDA申報的鹽酸吉西他濱注射液,規格為200mg/5.26mL,1g/26.3mL,2g/52.6mL單劑量的ANDA申請獲得批准。
鹽酸吉西他濱注射液原研產品為Hospira, Inc.持有,商品名為GEMCITABINE HYDROCHLORIDE,於2011年08月04日獲得美國FDA批准上市。
當前,美國境內,鹽酸吉西他濱注射液的主要生產廠商有Hospira, Inc.、Sun Pharmaceutical Industries, Inc.、Fresenius Kabi USA, LLC、Mylan InstitutionalLLC、Dr.Reddy's Laboratories Limited 等。
截至目前,公司在鹽酸吉西他濱注射液研發項目上已投入研發費用約人民幣473.30萬元。
新批准產品近期也將安排在美國上市銷售,有望對公司經營業績產生積極影響。
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