WHO 将 Qidong Dongyue Pharmaceutical Co., Ltd 生产的利托那韦原料药列入预认证
Active Pharmaceutical Ingredient (API) Prequalified
WHO 预认证团队宣布，由 Qidong Dongyue Pharmaceutical Co., Ltd 生产的利托那韦（Ritonavir）原料药已通过 WHO 原料药预认证程序。该程序包括评估原料药主文件（APIMF）以核查是否符合 WHO 规范与标准，以及评估原料药生产场地是否符合 WHO GMP 要求。含利托那韦的制剂用于 HIV/AIDS 治疗领域。
材料说明 WHO 原料药预认证由主文件评估与生产场地 GMP 评估两部分构成，可帮助读者理解该项资格认定的组成。
News
31 July, 2026 - 12:12 (CEST)
Announcement
Ritonavir manufactured by Qidong Dongyue Pharmaceutical Co., Ltd has been prequalified by the WHO Prequalification Team medicines under its API prequalification procedure.
Good-quality APIs are vital to the production of good-quality medicines. WHO prequalification of APIs facilitates production of quality medicines by identifying such APIs for use by manufacturers of finished pharmaceutical products (FPPs). FPPs containing Ritonavir are used in the therapeutic area of HIV/AIDS.
API prequalification consists of a comprehensive evaluation procedure that has two components: assessment of the API master file (APIMF) to verify compliance with WHO norms and standards, and evaluation of the sites of API manufacture to verify compliance with WHO Good Manufacturing Practice requirements.
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来源：WHO 药品预认证与检查动态 · extranet.who.int