WHO 将 Apitoria Pharma 生产的多替拉韦钠原料药列入预认证名单

Active Pharmaceutical Ingredient (API) Prequalified

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WHO 已将 M/s. Apitoria Pharma Private Limited 生产的多替拉韦钠原料药列入预认证名单。WHO 说明原料药预认证由两部分组成，即评估原料药主文件以核实是否符合 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。含多替拉韦钠的制剂用于 HIV/AIDS 治疗领域。

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22 June, 2026 - 00:12 (CEST)

Announcement

Dolutegravir (sodium) manufactured by M/s. Apitoria Pharma 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 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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