What Is a CADIFA Application in Brazil?

A CADIFA — Carta de Adequação do Dossiê de Insumo Farmacêutico Ativo — is a Letter of Suitability issued by ANVISA confirming that an Active Pharmaceutical Ingredient dossier (DIFA) has been evaluated and meets Brazilian regulatory standards. It is not a GMP certificate. It is not a marketing authorization. It is a standalone regulatory instrument with its own submission process, its own evaluation lifecycle, and its own set of consequences if absent.

Who must obtain one

Any domestic or foreign company whose API is used in a drug product registered or to be registered in Brazil must hold a valid CADIFA. The obligation became mandatory in August 2020 under RDC 359/2020. Only the DIFA holder — the entity that owns the Drug Master File — can submit the DIFA and request the CADIFA. The marketing authorization holder cannot do this on behalf of the API manufacturer.

When to activate the process

Before the marketing authorization application. The CADIFA request is a prerequisite for MA submission. The CADIFA application must be submitted prior to and associated with the MA submission. ANVISA does not require the CADIFA to be fully issued before the MA can be filed, but it will prioritize the CADIFA review when a linked MA application is in place.

What happens through Solicita

All DIFA submissions and CADIFA-related petitions are processed exclusively through Solicita, ANVISA's regulatory information system. Foreign manufacturers without a Brazilian legal entity (CNPJ) must complete a Registry Form, submit it by email to ANVISA, and obtain an Authorized User Number (AUN) before any submission can be initiated. No Brazilian regulatory agent is required for this step.

What happens if you don't have one

No CADIFA, no marketing authorization. For companies with existing registrations that predate the August 2020 mandatory enforcement, any major post-approval change application involving the API will also require a valid CADIFA to be linked. The absence of a CADIFA is not a procedural gap — it is a submission blocker.

If you are assessing your CADIFA status as part of an ANVISA registration or post-approval strategy, speak with our regulatory team [link to contact form] to map the correct sequence for your case.