Pharmaceutical & API manufacturing sites in Brazil
30 drug establishments in Brazil are registered with the US FDA; 11 (37%) list API manufacture among their operations. 27 registrant companies are identified, 1 of them with more than one API site here; sites whose registrant is not resolved to a company profile are not counted. 3 published sites are matched to an EU or UK GMP certificate inspected within the last three years.
Counts are physical site addresses in the FDA's current establishment register (US-facing sites only), not headquarters and not production volume. Methodology
- FDA-registered sites
- 30
- Registered for API manufacture
- 11
- Identified registrants
- 27
- Current EU/UK GMP match
- 3
Registered operations
| Analytical testing | 18 |
| API manufacture | 11 |
| Drug manufacture | 9 |
| Labelling | 7 |
| Packaging | 6 |
| Sterilisation | 2 |
| Medicated animal feed | 2 |
| Relabelling | 2 |
| Repackaging | 1 |
A site can register several operations, so these do not add up to the site total.
Companies headquartered in BrazilAPI manufacturing sites (11)
- Antibioticos do Brasil LtdaCosm�polisGMP match
- Ajinomoto do Brasil Industria e Comercio de Alimentos Ltda.Limeira
- Anidro Do Brasil Extracoes SAParnaiba
- H&N Homeopatia E Produtos NaturaisSao Paulo
- ITF CHEMICAL LTDACama�ari
- Kobo Brasil LtdaITUPEVA
- Nortec Quimica SADuque de Caxias
- Nutriplant Industria e Comercio S/ABarueri
- Phibro Saude Animal Internacional LtdaGUARULHOS (VILA SANT ANNA )
- Phibro Sa�de e Nutri��o Animal LtdaBRAGANCA PAULISTA (CIDADE PLANEJADA II )
- Sourcetech Quimica LtdaPINDAMONHANGABA
Other sites with EU/UK GMP documents (2)
Only sites registered with the US FDA appear, so manufacturing that serves only other markets is missing and these figures understate national capacity. A GMP match requires the certificate address to name the site's street and its city or postcode; an unmatched site is not an uncertified site.