普利製藥(300630.SZ):硝普鈉原料藥通過美國FDA的DMF審評
格隆匯 9 月 16日丨普利製藥(300630.SZ)公佈,公司於近日收到美國食品藥品監督管理局(“FDA”)簽發的硝普鈉原料藥已完成全面的科學審評、可以充分支持ANDA上市申請的通知函。
硝普鈉原料藥主要用於注射劑,其中硝普鈉注射液是一種血管擴張劑,主要用於:高血壓危象中立即降低成人和兒科患者的血壓;手術期間控制血壓以減少出血;治療急性充血性心力衰竭。
硝普鈉原料藥的獲批顯示了美國食品藥品監督管理局對公司該原料藥質量的肯定,體現了公司優秀的工藝研發和質量管控能力,為公司進一步拓展該品在國際市場的銷售提供了競爭基礎和優勢。本原料藥已用於支持我司生產的硝普鈉注射液(ANDA 214199)上市申請,該製劑已於8月獲得美國FDA批准。公司的硝普鈉原料藥其他市場的註冊工作仍在持續推進中。
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