WHO 预认证 Shanghai Neo-Leading Pharma Tech 生产的富马酸贝达喹啉原料药
Active Pharmaceutical Ingredient (API) Prequalified
WHO 药品预认证团队将 Shanghai Neo-Leading Pharma Tech Co., Ltd. 生产的富马酸贝达喹啉原料药列入原料药预认证，公告日期为 2026 年 10 月 13 日。预认证评估包含两部分，即审评原料药主文件（APIMF）以核实是否符合 WHO 规范和标准，以及评估原料药生产场地是否符合 WHO GMP 要求。含富马酸贝达喹啉的成品制剂用于结核病治疗领域。
材料列出该原料药通过 WHO 预认证的两项评估环节，可供了解原料药预认证程序的具体构成。
News
13 October, 2026 - 00:12 (CEST)
Announcement
Bedaquiline fumarate manufactured by Shanghai Neo-Leading Pharma Tech 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 bedaquiline fumarate are used in the therapeutic area of Tuberculosis.
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.
Links
来源：WHO 药品预认证与检查动态 · extranet.who.int