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 3002807185
Denmark, Denmark 3002807184

What they file, and where

Molecule Regulators Docs
Citalopram EDQM 1

Also appears on these molecule pages

Amitriptyline finished dose Citalopram API

Filings and GMP by regulator

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

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Open risk flags

  • The most recent inspection outcome was VAI, on 16 December 2022.

Sources on this page

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