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仙琚製藥(002332.SZ):楊府廠區原料藥產品通過日本GMP符合性檢查
格隆匯 12-13 17:17

格隆匯12月13日丨仙琚製藥(002332.SZ)公佈,近日,公司收到日本獨立行政法人醫藥品及醫療器械綜合機構(PMDA)簽發的《醫藥品適合性調查結果通知書》,公司楊府原料藥廠區的潑尼松龍原料藥通過日本GMP符合性檢查。該次通過日本GMP符合性檢查的潑尼松龍原料藥,是公司楊府廠區原料藥產品首次通過日本藥品監管部門審查。

潑尼松龍是一種強效糖皮質激素,其為前藥潑尼松的活性代謝物,廣泛用於抗炎和免疫抑制,潑尼松龍已被列入WHO基本藥物清單。潑尼松龍在治療各種急性和慢性疾病,包括哮喘、肝炎、關節炎、系統性紅斑狼瘡和過敏性皮膚病中表現出更高的抗炎活性和更低的鈉瀦留。

此次通過日本PMDA的GMP認證,標誌着公司楊府原料藥廠區的潑尼松龍原料藥獲得日本市場的准入資格,將對公司拓展日本及其他海外原料藥規範市場帶來積極影響。公司將保持穩定的生產管理和質量保證體系,更好地滿足全球客户需求,保障公司可持續發展。

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