WHO 将 Arene Life Sciences 生产的贝达喹啉（富马酸盐）原料药列入预认证
Active Pharmaceutical Ingredient (API) Prequalified
WHO 于 2026 年 9 月 16 日宣布，Arene Life Sciences Private Limited 生产的贝达喹啉（富马酸盐）原料药已通过其原料药预认证程序。
材料说明 WHO 原料药预认证由 API 主文件评估与生产场地 GMP 评估两部分组成，可帮助理解该项预认证的评审构成。
News
16 September, 2026 - 12:12 (CEST)
Announcement
Bedaquiline (fumarate) manufactured by Arene Life Sciences Private Limited 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.
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来源：WHO 药品预认证与检查动态 · extranet.who.int