Active Pharmaceutical Ingredients
This list contains sources of active pharmaceutical ingredients (APIs) that have been assessed by WHO and found to be acceptable, in principle, for use in manufacture of finished pharmaceutical products to be procured by UN agencies.
Prequalification of APIs generally involves evaluation of data relating to their quality, as well as inspection of the relevant manufacturing site(s).
The APIs listed are those for which the submitted data and information were found to meet — at the time of assessment — WHO norms and standards, and for which the relevant manufacturing sites were found to comply — at the time of inspection — with Good Manufacturing Practices.
Some of the APIs listed have been listed on the basis of assessment and inspection carried out by stringent regulatory authorities who are willing to share information with WHO.