Protalix Ltd.
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
A ANVISA, órgão regulador sanitário brasileiro, possui certificado de Boas Práticas de Fabricação válido para esta planta, abrangendo insumos farmacêuticos ativos biológicos, válido até 11/09/2027. O certificado é emitido após inspeção na própria fábrica, por isso um órgão regulador estrangeiro batiza este site: produtos fabricados aqui são permitidos no mercado brasileiro. Número do processo 25351381203202331.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Israel
- Categories
- Fabricação farmacêutica
- Markets
- Israel, Brasil
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 1 official record from 1 official source is on file. 2 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-09-02. OpenSanctions
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-09-02. OpenSanctions
- GMP certificate from a medicines agency (record type: gmp-certified) [official record; status green] A medicines regulator inspected the site and confirmed it may manufacture medicines. checked 2026-10-03. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
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)
Check independently
Before a first order, ask for the legal entity's registration number and country, then check it in the official register.