Active Pharmaceutical Ingredients
Pharmaceutical ingredients represents the beginning of the pharmaceutical industry's production chain. They are the "raw materials" used in the production of medicines. The active pharmaceutical ingredient, also known as API, is one of these raw materials. It is the substance that gives the medicine its pharmaceutical characteristic, is what makes a certain medicine work. To ensure quality in the production of medicines, Anvisa is responsible for inspecting companies and for the sanitary control of active pharmaceutical ingredients.
In 2020, Anvisa published a new framework for Active Pharmaceutical ingredients (APIs). Since then, Anvisa has issued the Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA) for APIs used in the manufacture of new, innovator, generic and similar drug products, in accordance with RDC 359/2020.