First dexamethasone and dexamethasone sodium phosphate Active Pharmaceutical Ingredients (APIs) prequalified

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27 January, 2021 - 15:30 (CET)

Dexamethasone (WHOAPI-411) and dexamethasone sodium phosphate (WHOAPI-412) manufactured by Tianjin Tianyao Pharmaceuticals Co Ltd have been prequalified by the WHO Prequalification Unit - Medicines Team (PQT/MED) under its API prequalification procedure.

WHOAPI-411 - Dexamethasone - Tianjin Tianyao Pharmaceuticals Co Ltd - CHINA
WHOAPI-412 - Dexamethasone sodium phosphate - Tianjin Tianyao Pharmaceuticals Co Ltd - CHINA
- FPPs containing dexamethasone and dexamethasone sodium phosphate are used in the therapeutic area of COVID-19
These represent the first dexamethasone and dexamethasone sodium phosphate APIs to be prequalified

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).

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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