Otsuka Pharmaceutical Co., Ltd, Saga Plant - B001203
Pianta certificata dall'ente regolatore sanitario brasiliano (ANVISA)
ANVISA, l'ente regolatore sanitario brasiliano, detiene un certificato di buona pratica di fabbricazione valido per questa pianta, che copre i principi farmaceutici attivi, valido fino al 30/10/2027. Il certificato viene rilasciato dopo un'ispezione dello stabilimento stesso, motivo per cui un regolatore straniero nomina questo sito: le merci prodotte qui sono ammesse sul mercato brasiliano. Numero di processo 25351568266202309.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Japan
- Categories
- Produzione farmaceutica
- Markets
- Giappone, Brasile
Listed in a source registry
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- gmp-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- debarment-clear (green), checked 2026-09-02 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- sanctions-clear (green), checked 2026-09-02 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
Import rules for these goods
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)