Operating Authorization (AFE)
1.32883-4
Authorized activities: import, store, distribute, dispatch and transport.
Documents that stand up to inspection
During an inspection, ANVISA looks at the process: where the API came from, who made it, what activities your supplier is authorized for. That is what we deliver with the batch.
Special Authorization (AE)
1.32878-8
For substances under special control (SVS/MS Ordinance No. 344/1998), including List C5.
Quality control
REBLAS-accredited laboratories
Quality control analysis of each batch is done in partnership with laboratories accredited by the Brazilian Network of Health Analytical Laboratories.
Authorizations checked in ANVISA’s public database on 21/09/2026. Check at consultas.anvisa.gov.br.
Per batch
What comes withthe batch
- Certificate of analysis (CoA) for the batch, issued by the manufacturer
- Import documents, with ANVISA approval
- Manufacturer and source plant details
- Invoice with batch and expiry date
Traceability
Traceability runs from the factory to your door: manufacturer qualified at the source, a certificate for every batch and analysis by an accredited laboratory.
