Suppliers / Lundbeck Pharmaceuticals Italy

Lundbeck Pharmaceuticals Italy

Italy Updated 9 July 2026

Lundbeck Pharmaceuticals Italy is a contract manufacturer based in Italy. It holds 8 active US drug master files and one valid CEP across a filed portfolio of 8 molecules. Its most recent recorded inspection, by US FDA, closed on 25 March 2022 as VAI.

8
active US DMFs
1
valid CEPs
2
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 25 March 2022 VAI US FDA
  • 12 May 2017 VAI US FDA
  • 17 April 2015 NAI US FDA
  • 28 September 2012 NAI US FDA
  • 13 March 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Padova, Italy Not on file
Italy, Italy 3002808449

What they file, and where

Molecule Regulators Docs
Trimipramine EDQM, US FDA 2
(21R)-Argatroban US FDA 1
Clomipramine US FDA 1
Dapsone US FDA 1
Desipramine US FDA 1
Diazoxide US FDA 1
Imipramine US FDA 1
Metoclopramide US FDA 1

Also appears on these molecule pages

Citalopram contract manufacturing Clomipramine contract manufacturing Dapsone contract manufacturing Diazoxide contract manufacturing Escitalopram contract manufacturing Metoclopramide contract manufacturing Naltrexone contract manufacturing Pimavanserin contract manufacturing Safinamide contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MPA (SE) 1 None

Questions about Lundbeck Pharmaceuticals Italy

Does Lundbeck Pharmaceuticals Italy hold a US DMF or a CEP?
Lundbeck Pharmaceuticals Italy holds 8 active US drug master files and 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 Lundbeck Pharmaceuticals Italy FDA-registered?
One site operated by Lundbeck Pharmaceuticals Italy carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Lundbeck Pharmaceuticals Italy's last inspection go?
The most recent inspection on record closed on 25 March 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Lundbeck Pharmaceuticals Italy manufacture?
2 registered sites are on record, in Italy (Padova and Italy). Every site is listed on this page with the register it came from.
What does Lundbeck Pharmaceuticals Italy make?
8 molecules are on record against Lundbeck Pharmaceuticals Italy, including Trimipramine, (21R)-Argatroban, Clomipramine and Dapsone. Each links through to that molecule's full manufacturer list.
Where does Lundbeck Pharmaceuticals Italy file?
Filings are on record with MPA (SE), 1 in total.

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 25 March 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