WHO 原料药预认证：Micro Labs Limited 的多替拉韦（钠）通过 API 预认证

Active Pharmaceutical Ingredient (API) Prequalified

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Micro Labs Limited 生产的多替拉韦（钠）已通过 WHO 药品预认证团队的原料药预认证程序。该预认证包括原料药主文件（APIMF）评估和原料药生产场地 GMP 符合性检查两部分。含多替拉韦（钠）的制剂用于 HIV/AIDS 治疗领域。

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27 October, 2026 - 12:12 (CET)

Announcement

Dolutegravir (sodium) manufactured by Micro Labs 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 Dolutegravir (sodium) 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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