Brazil: Overview of API registration

Regulatory Affairs in Latin America

In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, imported for manufacturing of drug products, or included in imported finished products, are registered with the agency.

This regulation has been put in place in 2009, and the implementation has been gradual: ANVISA created a scheme that includes the different API categories in different “waves” of implementation.

In the first implementation wave (deadlines to register in 2010) the following drug substances were included: Cyclosporine, Clozapine, Clindamycin Chlorhydrate, Ciclophosphamide, Ciprofloxacin, Methotrexate, Carbamazepine, Lithium Carbonate, Phenytoin, Sodium Phenytoin, Lamivudine, Penicillamine, Thiabendazole, Efavirenz, Nevirapine, Rifampicin, Ritonavir, Zidovudine, Acyclovir and Ampicillin.

In June 2013, the second implementation wave was announced, including the following substances: Azithromycin, Benzylpenicillin, Cabergoline, Carboplatin, Cephalexin, Cephalothin, Ceftazidime, Cisplatin, Clarithromycin, Ceftriaxone and their respective salts, esters, ethers and hydrates, and the salts, esters, ethers and hydrates of the APIs included in the first…

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