Suppliers / H. Lundbecks A/S

H. Lundbecks A/S

Denmark Updated 9 July 2026

H. Lundbecks A/S is an API and finished-dose manufacturer based in Denmark. It holds one valid CEP. Its GMP standing is certified by ANVISA (Brazil) and EMA. Its most recent recorded inspection, by US FDA, closed on 16 December 2022 as VAI.

0
active US DMFs
1
valid CEPs
4
registered plants 2 with an FDA FEI number
16
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
EU GMP
0 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 16 December 2022 VAI US FDA
  • 16 November 2022 VAI US FDA
  • 1 July 2020 VAI US FDA
  • 27 April 2018 VAI US FDA
  • 13 May 2016 NAI US FDA
  • 6 May 2016 NAI US FDA
  • 17 June 2013 NAI US FDA
  • 10 June 2013 NAI US FDA

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

Registered plants

Site FDA FEI
COPENHAGEN, Denmark Not on file
Valby, Denmark Not on file
Denmark, Denmark 3002807184
Denmark, Denmark 3002807185

What they file, and where

Molecule Regulators Docs
Citalopram EDQM 1

Also appears on these molecule pages

Amitriptyline finished dose Citalopram API Nortriptyline finished dose Vortioxetine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 16 1
ANVISA (Brazil) None 3

Questions about H. Lundbecks A/S

Does H. Lundbecks A/S hold a US DMF or a CEP?
H. Lundbecks A/S holds 1 valid CEP. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is H. Lundbecks A/S FDA-registered?
2 sites operated by H. Lundbecks 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 H. Lundbecks A/S's last inspection go?
The most recent inspection on record closed on 16 December 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does H. Lundbecks A/S manufacture?
4 registered sites are on record, in Denmark (Copenhagen, Valby and Denmark among others). Every site is listed on this page with the register it came from.
What does H. Lundbecks A/S make?
1 molecule is on record against H. Lundbecks A/S, including Citalopram. Each links through to that molecule's full manufacturer list.
Which regulators recognise H. Lundbecks A/S's GMP?
Current GMP certificates are on record from ANVISA (Brazil) and EMA. 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 VAI, on 16 December 2022.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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