九典制藥(300705.SZ):乙酰半胱氨酸顆粒獲得藥品註冊證書
格隆匯10月14日丨九典制藥(300705.SZ)公佈,公司於近日收到國家藥品監督管理局下發的《藥品註冊證書》。相關藥品為乙酰半胱氨酸顆粒。
酰半胱氨酸系粘液溶解劑,具有較強的粘痰溶解作用,適用於慢性支氣管炎等咳嗽有粘痰而不易咳出的患者。作為OTC祛痰藥,其療效顯著、安全性高,臨牀應用廣泛、市場需求量大。
乙酰半胱氨酸顆粒最早由ZAMBON製藥在瑞士上市,規格100mg、200mg,商品名為Fluimucil®,同步上市了泡騰片(規格600mg),後續推出了片劑(規格600mg)和顆粒劑(規格600mg)、注射劑(規格100mg/ml、200mg/ml),乙酰半胱氨酸顆粒相繼在意大利、中國等國家上市,原研顆粒劑地產化進入國內,商品名為富露施®。
截至公吿日,乙酰半胱氨酸顆粒國內共有3家(含公司和原研)企業取得了藥品註冊證書。公司該品種按照新註冊分類4申報,為國內第1家通過或視同通過仿製藥質量和療效一致性評價的企業。
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