仁和藥業(000650.SZ):苯磺酸氨氯地平片通過仿製藥一致性評價
格隆匯1月21日丨仁和藥業(000650.SZ)公佈,近日,公司下屬子公司江西製藥有限責任公司收到國家藥品監督管理局核准簽發的關於苯磺酸氨氯地平片的《藥品補充申請批件》,該藥品通過仿製藥質量和療效一致性評價(“仿製藥一致性評價”)。
藥品名稱:苯磺酸氨氯地平片;劑型:片劑;規格:5mg(按C20H25CIN2O5計);註冊分類:化學藥品;受理號:CYHB1850425;批件號:2020B02002;原藥品批准文號:國藥準字H20083949審批結論:根據《中華人民共和國藥品管理法》《國務院關於改革藥品醫療器械審評審批制度的意見》(國發(2015)44號)和《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)的規定,經審查,本品通過仿製藥質量和療效一致性評價,同時同意本品變更處方、生產工藝、註冊標準等。本品質量標準按所附執行,有效期18個月。本品原料藥生產商為Cadila Pharmaceuticals Limited。今後商業化生產如進行批量變更,請注意開展相應的研究及驗證,必要時提出補充申請。
2018年12月14日,江西製藥有限責任公司向國家藥監局遞交的本品仿製藥一致性評價申請獲受理。苯磺酸氨氯地平片,適應症為:高血壓、冠心病、心絞痛。苯磺酸氨氯地平片商品名“絡活喜”(NORVASC?),原研廠家為輝瑞製藥有限公司(PfizerInc.)。
公司的苯磺酸氨氯地平片通過仿製藥一致性評價,有利於提升該藥品的市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了經驗。
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