Suppliers / LEO Pharma A/S

LEO Pharma A/S

Denmark 2 duplicate records merged Updated 9 July 2026

LEO Pharma A/S is an API and finished-dose manufacturer based in Denmark. It holds 2 active US drug master files and 11 valid CEPs across a filed portfolio of 5 molecules. Its filings concentrate with AIFA (IT), EMA and ANVISA (Brazil). Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 26 September 2024 as VAI.

2
active US DMFs
11
valid CEPs
6
registered plants 1 with an FDA FEI number
542
filings across 17 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
EU GMP
1 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

  • 26 September 2024 VAI US FDA
  • 17 June 2021 VAI US FDA
  • 21 March 2014 VAI US FDA
  • 15 September 2011 VAI US FDA
  • 15 July 2011 VAI US FDA
  • 16 June 2009 OAI US FDA

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

Registered plants

Site FDA FEI
Ballerup, United Arab Emirates Not on file
São Paulo, Brazil Not on file
SAO PAULO, Brazil Not on file
Ballerup, Denmark Not on file
Ballerup, Denmark Not on file
Denmark, Denmark 3002807496

What they file, and where

Molecule Regulators Docs
Calcipotriol EDQM, SFDA (Saudi Arabia), US FDA 5
Sodium Fusidate EDQM 4
Fusidic Acid EDQM 3
Alfacalcidol EDQM 1
Heparin Sodium EDQM 1

Also appears on these molecule pages

Betamethasone finished dose Dolutegravir finished dose Fusidic Acid API Heparin API Methylprednisolone finished dose Salicylic Acid finished dose Tacrolimus finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 141 None
EMA 115 1
ANVISA (Brazil) 50 None
INFARMED (PT) 43 None
Health Canada 39 None
DKMA (DK) 28 None
US FDA None 1

Comparing suppliers?

Choose your molecules and target markets. LEO Pharma A/S comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • 26 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 26 September 2024.

Sources on this page

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