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嘉應制藥(002198.SZ):國家藥監局修訂接骨七釐片/膠囊處方標準
格隆匯 11-11 17:38

格隆匯 11 月 11日丨嘉應制藥(002198.SZ)公佈,公司下屬全資子公司湖南金沙藥業有限責任公司(“金沙藥業”)收到藥監局下發的《國家藥品標準(修訂)頒佈件》(批件號ZGB2020-18、ZGB2020-19),藥監局根據《藥品管理法》及其有關規定,對金沙藥業主要產品接骨七釐片/膠囊的處方標準進行修訂,將標準中處方項下“龍血竭”恢復為“血竭”,刪除龍血竭的TLC鑑別,該標準過渡期為自標準頒佈之日起12個月。

藥品名稱:接骨七釐片、接骨七釐膠囊;劑型:片劑、膠囊劑;標準依據:局頒標準;標準號:WS3-B-3488-98-2011-2020、WS3-424(Z-72)-2010Z-2020;審定單位:國家藥典委員會;修訂內容與結論:根據《藥品管理法》及其有關規定,經審查,同意修訂接骨七釐片/膠囊的藥品標準,將質量標準中處方項下“龍血竭”恢復為“血竭”:刪除龍血竭的TLC鑑別。

金沙藥業生產的接骨七釐片/膠囊已依法依規取得國家生產批文,在2004年即成為《國家基本藥物目錄》的品種,且獲得了“湖南省產品質量獎”、“湖南名牌產品”稱號。二十多年來,該產品深得廣大患者認可,療效確切,價格合理,未發現不良反應。接骨七釐片/膠囊2019年度銷售收入為人民幣3.43億元,佔公司2019年度營業總收入的比重為68.52%。

此次藥監局修訂該產品處方標準後,金沙藥業在該標準實施之日起必須按照該標準生產藥品,並按照該標準檢驗,同時停止使用原標準,即將處方中一種主要成分“龍血竭”替換成“血竭”。原材料“血竭”資源較為匱乏、價格較高。在配方中採用“血竭”,將增加上述產品的生產成本,極大影響金沙藥業業績,對公司未來的淨利潤造成負面影響。

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