Alvotech Hf.
Plante certifiée par le régulateur brésilien de la santé (ANVISA)
ANVISA, le régulateur brésilien de la santé, détient un certificat de bonnes pratiques de fabrication valide pour cette plante, couvrant les ingrédients pharmaceutiques actifs biologiques, valable jusqu'au 2028-01-15. Le certificat est délivré après une inspection de l'usine elle-même, c'est pourquoi un régulateur étranger nomme ce site : les produits fabriqués ici sont autorisés sur le marché brésilien. Numéro de processus 25351117386202333.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Iceland
- Categories
- Production pharmaceutique
- Markets
- Islande, Brésil
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)
- registered-manufacturer (green), checked 2026-08-21 Superintendencia de Regulacion Sanitaria de El Salvador, listado de productos farmaceuticos con registro sanitario vigente
- debarment-clear (green), checked 2026-08-31 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- sanctions-clear (green), checked 2026-08-31 - 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)