Active Pharmaceutical Ingredients
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, in Portuguese) for APIs used in the manufacture of new, innovative, generic, and similar medicinal products, in accordance with RDC 359/2020.
Supporting Materials
Normative
Guidance