WHO 将 Anuh Pharma Ltd. 的阿莫地喹（盐酸盐）原料药列入预认证

Active Pharmaceutical Ingredient (API) Prequalified

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WHO 于 5 月 7 日公告，Anuh Pharma Ltd. 生产的阿莫地喹（盐酸盐）原料药已通过 WHO 原料药预认证。含该原料药的制剂用于疟疾治疗领域，预认证旨在为制剂生产商指明可用的高质量原料药来源。WHO 原料药预认证由两部分评估构成，即原料药主文件（APIMF）合规评估与原料药生产场地 GMP 合规评估。

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7 May, 2026 - 00:12 (CEST)

Announcement

Amodiaquine (hydrochloride) manufactured by Anuh Pharma 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 Amodiaquine (hydrochloride) are used in the therapeutic area of Malaria.

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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