A CADIFA is a letter from Anvisa meaning that a certain drug master file (DMF) was evaluated by the agency and considered to be approved.


A CADIFA can only be requested by the DIFA holder, which is the company that possesses the knowledge about the entire manufacturing process of the API and is responsible for this process from the introduction of the starting material.

The DIFA holder may or may not be the API manufacturer. There is no fee to obtain a CADIFA, the only fee needed is to request for the GMP certificate to be issued by Anvisa, and the cGMP also needs renewal. Moreover, the company requesting it must be legally established in Brazil.

If a company is only a trader, and not part of the same group as the API manufacturer, this trader cannot be the DIFA holder, hence it cannot request a CADIFA.

Situations when a CADIFA can be requested:

  • Anvisa will prioritize CADIFA requests associated with a MAH application, which can be a new submission or a post-approval variation.
  • Expression of interest.
  • Invitation by Dicol
  • Independent of the situation, the DIFA holder will submit its DIFA to Anvisa, which could be an electronic or non-electronic submission.


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