Suppliers / ALK-Abelló A/S

ALK-Abelló A/S

United States 2 duplicate records merged Updated 9 July 2026

ALK-Abelló A/S is a finished-dose manufacturer based in United States. It appears in 363 regulatory filings across 15 regulators, without an active US DMF or CEP on file. Its filings concentrate with MPA (SE), DKMA (DK) and MHRA (UK). Its GMP standing is certified by ANSM (FR) and US FDA. Its most recent recorded inspection, by US FDA, closed on 13 June 2025 as OAI.

0
active US DMFs
0
valid CEPs
4
registered plants 2 with an FDA FEI number
363
filings across 15 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 13 June 2025 OAI US FDA
  • 17 October 2023 VAI US FDA
  • 9 March 2023 VAI US FDA
  • 21 October 2022 OAI US FDA
  • 3 May 2021 OAI US FDA
  • 29 November 2018 NAI US FDA
  • 30 October 2018 VAI US FDA
  • 19 September 2017 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
MADRIDE, United Arab Emirates Not on file
Vandeuil, France Not on file
Plainville, United States 3006900385
Port Washington, United States 2431784

Filings and GMP by regulator

Regulator Filings GMP certificates
MPA (SE) 116 None
DKMA (DK) 46 None
MHRA (UK) 36 None
DMP (NO) 32 None
Health Canada 31 None
EMA 30 None
ANSM (FR) None 2
US FDA None 1

Questions about ALK-Abelló A/S

Does ALK-Abelló A/S hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for ALK-Abelló A/S. It does have 363 filings with 15 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is ALK-Abelló A/S FDA-registered?
2 sites operated by ALK-Abelló A/S carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did ALK-Abelló A/S's last inspection go?
The most recent inspection on record closed on 13 June 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 3 closed as OAI.
Where does ALK-Abelló A/S manufacture?
4 registered sites are on record, in United Arab Emirates, France and United States (Madride, Vandeuil and Plainville among others). Every site is listed on this page with the register it came from.
Which regulators recognise ALK-Abelló A/S's GMP?
Current GMP certificates are on record from ANSM (FR) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was OAI, on 13 June 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates