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.
ANVISA, die brasilianische Gesundheitsbehörde, verfügt für dieses Werk über ein gültiges Good Manufacturing Practice-Zertifikat, das biologisch aktive pharmazeutische Inhaltsstoffe abdeckt und bis zum 11.09.2027 gültig ist. Das Zertifikat wird nach einer Inspektion des Werks selbst ausgestellt, weshalb eine ausländische Aufsichtsbehörde diesen Standort nennt: Hier hergestellte Waren dürfen auf den brasilianischen Markt gelangen. Prozessnummer 25351381203202331.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Israel
- Categories
- Pharmazeutische Produktion
- Markets
- Israel, Brasilien
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.