WHO 预认证江西迪赛诺制药生产的拉米夫定原料药

Active Pharmaceutical Ingredient (API) Prequalified

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WHO 药品预认证团队按原料药预认证程序，将江西迪赛诺制药有限公司生产的拉米夫定原料药列入预认证名单，公告日期为 2026 年 9 月 17 日。原料药预认证包括对原料药主文件（APIMF）的评估，以及对原料药生产场地的 WHO GMP 符合性评估两部分。含拉米夫定的制剂用于 HIV/AIDS 治疗领域。

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17 September, 2026 - 12:12 (CEST)

Announcement

Lamivudine manufactured by Jiangxi Desano 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 Lamivudine 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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