WHO 将 Resonance Specialities Limited 生产的吡嗪酰胺原料药列入预认证

Active Pharmaceutical Ingredient (API) Prequalified

AI 导读

WHO 预认证团队将 Resonance Specialities Limited 生产的吡嗪酰胺原料药列入预认证。含吡嗪酰胺的制剂用于结核病治疗领域。WHO 原料药预认证由两部分组成，评估原料药主文件 APIMF 是否符合 WHO 规范与标准，并评估原料药生产场地是否符合 WHO GMP 要求。

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24 August, 2026 - 00:12 (CEST)

Announcement

Pyrazinamide manufactured by Resonance Specialities 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 pyrazinamide 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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