Novo Nordisk A/S

Kalundborg, DenmarkFEI 3002807751API manufacture registered

Novo Nordisk A/S is a drug establishment in Kalundborg, Denmark, registered with the US FDA under FEI 3002807751. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 11 EU/UK GMP certificates are matched to this site, 10 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 (11)

DocumentAuthorityInspectionSource
DK H 10001541
GMP certificate
Competent authority of Denmark18 Jun 2026
within 3-year review window
EudraGMDP
DK API-H 10001542
GMP certificate
Competent authority of Denmark18 Jun 2026
within 3-year review window
EudraGMDP
DK H 10001516
GMP certificate
Competent authority of Denmark15 Apr 2026
within 3-year review window
EudraGMDP
DK H 10001413
GMP certificate
Competent authority of Denmark15 Jan 2026
within 3-year review window
EudraGMDP
DK IMP 10001400
GMP certificate
Competent authority of Denmark9 Jan 2026
within 3-year review window
EudraGMDP
DK IMP 10001299
GMP certificate
Competent authority of Denmark10 Jun 2025
within 3-year review window
EudraGMDP
DK H 10001298
GMP certificate
Competent authority of Denmark10 Jun 2025
within 3-year review window
EudraGMDP
DK API-H 10001300
GMP certificate
Competent authority of Denmark10 Jun 2025
within 3-year review window
EudraGMDP
DK H 10001048
GMP certificate
Competent authority of Denmark2 Oct 2024
within 3-year review window
EudraGMDP
DK H 10001049
GMP certificate
Competent authority of Denmark2 Oct 2024
within 3-year review window
EudraGMDP
DK H 10000822
GMP certificate
Competent authority of Denmark30 Aug 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.

Other sites registered by the same company