WHO 预认证 Viyash Scientific Limited 生产的阿巴卡韦（硫酸盐）原料药（WHOAPI-516）

Active Pharmaceutical Ingredient (API) Prequalified

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WHO 药品预认证团队依据原料药预认证程序，对 Viyash Scientific Limited 生产的阿巴卡韦（硫酸盐）（WHOAPI-516）作出预认证。该程序包括评估原料药主文件（APIMF）以核实是否符合 WHO 规范与标准，以及评估原料药生产场地以核实是否符合 WHO GMP 要求。含阿巴卡韦（硫酸盐）的制剂用于 HIV/AIDS 治疗领域。

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13 October, 2026 - 00:12 (CEST)

Announcement

Abacavir (sulfate) (WHOAPI-516) manufactured by Viyash Scientific 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 abacavir (sulfate) 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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