AGC Biologics A/S

Soeborg, DenmarkFEI 3004708748API manufacture registered

AGC Biologics A/S is a drug establishment in Soeborg, Denmark, registered with the US FDA under FEI 3004708748. Its registered operations are: Analytical testing, API manufacture. 8 EU/UK GMP certificates are matched to this site, 4 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 manufacture

GMP documents matched to this site (8)

DocumentAuthorityInspectionSource
DK H 10001485
GMP certificate
Competent authority of Denmark19 Feb 2026
within 3-year review window
EudraGMDP
DK IMP 10001474
GMP certificate
Competent authority of Denmark19 Feb 2026
within 3-year review window
EudraGMDP
DK H 10001473
GMP certificate
Competent authority of Denmark19 Feb 2026
within 3-year review window
EudraGMDP
DK API-H 10001475
GMP certificate
Competent authority of Denmark19 Feb 2026
within 3-year review window
EudraGMDP
DK H 10000842
GMP certificate
Competent authority of Denmark29 Jun 2023
outside 3-year review window
EudraGMDP
DK API-H 10000840
GMP certificate
Competent authority of DENMARK29 Jun 2023
outside 3-year review window
EudraGMDP
DK H 10000841
GMP certificate
Competent authority of Denmark29 Jun 2023
outside 3-year review window
EudraGMDP
DK IMP 10000843
GMP certificate
Competent authority of Denmark29 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.