Alk-abello A/s

Horsholm, DenmarkFEI 3002806343API manufacture registered

Alk-abello A/s is a drug establishment in Horsholm, Denmark, registered with the US FDA under FEI 3002806343. Its registered operations are: Analytical testing, API manufacture, Drug manufacture. 9 EU/UK GMP certificates are matched to this site, 9 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 manufactureDrug manufacture

GMP documents matched to this site (9)

DocumentAuthorityInspectionSource
DK API-H 10001554
GMP certificate
Competent authority of Denmark23 Apr 2026
within 3-year review window
EudraGMDP
DK IMP 10001553
GMP certificate
Competent authority of Denmark23 Apr 2026
within 3-year review window
EudraGMDP
DK H 10001555
GMP certificate
Competent authority of Denmark23 Apr 2026
within 3-year review window
EudraGMDP
DK IMP 10001556
GMP certificate
Competent authority of Denmark23 Apr 2026
within 3-year review window
EudraGMDP
DK H 10001457
GMP certificate
Competent authority of Denmark14 Apr 2026
within 3-year review window
EudraGMDP
DK IMP 10001031
GMP certificate
Competent authority of Denmark14 Aug 2024
within 3-year review window
EudraGMDP
DK H 10000922
GMP certificate
Competent authority of Denmark16 Nov 2023
within 3-year review window
EudraGMDP
DK IMP 10000924
GMP certificate
Competent authority of Denmark16 Nov 2023
within 3-year review window
EudraGMDP
DK API-H 10000923
GMP certificate
Competent authority of DENMARK16 Nov 2023
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.