聖濟堂(600227.SH):聖濟堂製藥甲巰咪唑原料藥通過藥品GMP現場檢查
格隆匯12月14日丨聖濟堂(600227.SH)公佈,根據貴州省藥品監督管理局發佈的《貴州省藥品GMP現場檢查結果公告》,公司全資子公司聖濟堂製藥原料藥(甲巰咪唑)經現場檢查和綜合評定,符合藥品GMP要求。
甲巰咪唑(原料藥)適應症為甲狀腺功能亢進、甲狀腺增大,是國家短缺藥品目錄品種、國家醫保甲類品種,國家基本藥物目錄。根據國家藥品監督管理局南方所提供的數據,國內甲巰咪唑主要市場份額是外資企業默克雪蘭諾公司佔據96.75%(公立醫院),價格是0.53元/片,國內企業製劑生產文號15個,其中13個文號是每片5mg的批文,聖濟堂製藥甲巰咪唑腸溶片(10mg)是國內獨家規格的批文。
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