Fujifilm Diosynth Biotechnologies Denmark Aps
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 27.05.2028 gültig ist. Das Zertifikat wird nach einer Inspektion des Werks selbst ausgestellt, weshalb eine ausländische Aufsichtsbehörde diesen Standort nennt: Hier hergestellte Waren sind auf dem brasilianischen Markt zugelassen. Prozessnummer 25351092634202083.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Denmark
- Categories
- Pharmazeutische Produktion
- Markets
- Dänemark, Brasilien
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 8 official records from 8 official sources are 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
- Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-08-23. GLEIF global LEI register (golden copy)
- Operating permit for the production site (record type: operating-permit; this record does not by itself establish manufacturing) [official record; status green] Shows an authority issued a permit for an installation at this site for the activity named in the record. A permit is not an inspection report and not an observation that production is running today. effective since 2026-08-08. Digital MiljoAdministration (DMA), Danish environmental register
- Listed in a source registry (record type: listed-in-registry) [official record; status amber] Listed in Erhvervsstyrelsen; entry number 26060702. Matched to this company by name only; no second anchor confirms it is the same legal entity.. Found in a named public register, not only on its own website. checked 2026-09-02. BRIS, EU business registers interconnection (e-justice.europa.eu)
- registry-activity (record type: registry-activity) [official record; status green] Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-09-23. Lægemiddelstyrelsen, virksomheder med tilladelse efter § 39 stk. 1
- Annual accounts filed with the register (record type: annual-accounts-filed) [official record; status green] Indicates the company still meets its reporting duties. checked 2026-09-23. Erhvervsstyrelsen, offentliggjorte årsrapporter (virk.dk)
- 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)
- 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. checked 2026-09-02. OpenSanctions
- 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. checked 2026-09-02. OpenSanctions
- Medicines manufacturing or import authorisation (MIA) (record type: medicines-mia-holder) [official record; status green] A medicines regulator authorises this company to manufacture and/or import medicinal products at the named site. The register lists the authorisation itself, not which products it covers, and it is not a record of trading. effective since 2026-08-15. EudraGMDP manufacturing and importation authorisation register (EMA)
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-10. GLEIF Global LEI record
Relationships
1 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Recorded in a source
- 26060702: Holds the site's permit, registry number 26060702. Digital MiljoAdministration (DMA), Danish environmental register
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)