Bavarian Nordic A/S

Kvistgaard, DenmarkFEI 3008318564API manufacture registered

Bavarian Nordic A/S is a drug establishment in Kvistgaard, Denmark, registered with the US FDA under FEI 3008318564. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 8 EU/UK GMP certificates are matched to this site, 8 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 (8)

DocumentAuthorityInspectionSource
DK H 10001386
GMP certificate
Competent authority of Denmark9 Oct 2025
within 3-year review window
EudraGMDP
DK IMP 10001387
GMP certificate
Competent authority of Denmark9 Oct 2025
within 3-year review window
EudraGMDP
DK API-H 10001173
GMP certificate
Competent authority of Denmark24 Jan 2025
within 3-year review window
EudraGMDP
DK IMP 10001162
GMP certificate
Competent authority of Denmark24 Jan 2025
within 3-year review window
EudraGMDP
DK H 10001161
GMP certificate
Competent authority of Denmark24 Jan 2025
within 3-year review window
EudraGMDP
DK H 10000980
GMP certificate
Competent authority of Denmark19 Apr 2024
within 3-year review window
EudraGMDP
DK IMP 10000981
GMP certificate
Competent authority of Denmark19 Apr 2024
within 3-year review window
EudraGMDP
DK API-H 10000979
GMP certificate
Competent authority of Denmark19 Apr 2024
within 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.

Other sites registered by the same company