濟川藥業(600566.SH):子公司琥珀酸普蘆卡必利片獲得藥品註冊證書
格隆匯12月7日丨濟川藥業(600566.SH)宣佈,近日,公司下屬全資子公司濟川有限收到國家藥監局核准簽發的琥珀酸普蘆卡必利片(1mg,2mg)《藥品註冊證書》。
琥珀酸普蘆卡必利是一種二氫苯並呋喃甲酰胺類化合物,為選擇性、高親和力的五羥色胺(5-HT4)受體激動劑,具有促腸動力活性。適應症為用於治療成年女性患者中通過輕瀉劑難以充分緩解的慢性便祕症狀。截至目前,該藥品累計研發支出約1200萬元(未經審計),均已費用化。
目前國內琥珀酸普蘆卡必利片通過及視同通過一致性評價的廠家有石家莊四藥有限公司、河北仁合益康藥業有限公司、江蘇豪森藥業集團有限公司以及濟川有限,共4家。
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