FUJIFILM Diosynth Biotechnologies Denmark ApS

Hillerod, DenmarkFEI 3006339887API manufacture registered

FUJIFILM Diosynth Biotechnologies Denmark ApS is a drug establishment in Hillerod, Denmark, registered with the US FDA under FEI 3006339887. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 24 EU/UK GMP certificates are matched to this site, 21 inspected within the last three years.

Sources: FDA Drug Establishments Current Registration Site (checked 2 Nov 2026); EudraGMDP; MHRA GMDP. Methodology

Registered operations

Business operations this establishment declares in its FDA registration. Registration is not an approval and says nothing about EU or UK GMP status.

Analytical testingAPI manufactureLabellingDrug manufacturePackaging

GMP documents matched to this site (24)

DocumentAuthorityInspectionSource
DK H 10001511
GMP certificate
Competent authority of Denmark21 May 2026
within 3-year review window
EudraGMDP
DK API-H 10001510
GMP certificate
Competent authority of Denmark21 May 2026
within 3-year review window
EudraGMDP
DK IMP 10001540
GMP certificate
Competent authority of Denmark21 May 2026
within 3-year review window
EudraGMDP
DK API-H 10001538
GMP certificate
Competent authority of Denmark21 May 2026
within 3-year review window
EudraGMDP
DK IMP 10001512
GMP certificate
Competent authority of Denmark21 May 2026
within 3-year review window
EudraGMDP
DK H 10001539
GMP certificate
Competent authority of Denmark21 May 2026
within 3-year review window
EudraGMDP
DK H 10001414
GMP certificate
Competent authority of Denmark4 Mar 2026
within 3-year review window
EudraGMDP
DK IMP 10001415
GMP certificate
Competent authority of Denmark4 Mar 2026
within 3-year review window
EudraGMDP
DK H 10001468
GMP certificate
Competent authority of Denmark6 Feb 2026
within 3-year review window
EudraGMDP
DK IMP 10001469
GMP certificate
Competent authority of Denmark6 Feb 2026
within 3-year review window
EudraGMDP
DK IMP 10001268
GMP certificate
Competent authority of Denmark12 Jun 2025
within 3-year review window
EudraGMDP
DK API-H 10001266
GMP certificate
Competent authority of Denmark12 Jun 2025
within 3-year review window
EudraGMDP
DK H 10001269
GMP certificate
Competent authority of Denmark12 Jun 2025
within 3-year review window
EudraGMDP
DK API-H 10001234
GMP certificate
Competent authority of Denmark4 Feb 2025
within 3-year review window
EudraGMDP
DK IMP 10001236
GMP certificate
Competent authority of Denmark4 Feb 2025
within 3-year review window
EudraGMDP
DK H 10001235
GMP certificate
Competent authority of Denmark4 Feb 2025
within 3-year review window
EudraGMDP
DK H 10001233
GMP certificate
Competent authority of Denmark21 Jan 2025
within 3-year review window
EudraGMDP
DK API-H 10001232
GMP certificate
Competent authority of Denmark21 Jan 2025
within 3-year review window
EudraGMDP
DK IMP 10001237
GMP certificate
Competent authority of Denmark21 Jan 2025
within 3-year review window
EudraGMDP
DK H 10000994
GMP certificate
Competent authority of Denmark19 Jun 2024
within 3-year review window
EudraGMDP
DK IMP 10000995
GMP certificate
Competent authority of Denmark19 Jun 2024
within 3-year review window
EudraGMDP
DK H 10000769
GMP certificate
Competent authority of Denmark30 Jun 2023
outside 3-year review window
EudraGMDP
DK IMP 10000770
GMP certificate
Competent authority of Denmark30 Jun 2023
outside 3-year review window
EudraGMDP
DK API-H 10000771
GMP certificate
Competent authority of Denmark30 Jun 2023
outside 3-year review window
EudraGMDP

A GMP document is matched to this site when its address names the site's street and its city or postcode. In our latest internal review 59 of 60 sampled matches were the right site (not yet independently reviewed; measured match quality). Check the certificate's own address before relying on it. The three-year review window is the EMA guideline default after an inspection, not an official expiry date.

What this page does not show

  • Which substances are made here: DMFs and CEPs are filed by organisations, not sites, so we do not link substances to this site.
  • Capacity, scale, price or current availability: no regulator publishes these.
  • FDA inspection classifications for this site, which are not yet linked.