Suppliers / Leo Pharma

Leo Pharma

Denmark reconciled across 35 public records · 21 entities Updated 9 July 2026

Leo Pharma 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 Health Canada. Its GMP standing is certified by ANVISA (Brazil), EMA and US FDA, among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 26 September 2024 as VAI.

2
active US DMFs
11
valid CEPs
15
registered plants 3 with an FDA FEI number
877
filings across 27 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
  • 30 November 2023 VAI US FDA
  • 24 June 2022 VAI US FDA
  • 17 June 2021 VAI US FDA
  • 25 July 2019 VAI US FDA
  • 3 November 2017 NAI US FDA
  • 11 September 2014 NAI US FDA
  • 21 March 2014 VAI US FDA
  • 14 March 2014 NAI US FDA
  • 28 March 2012 NAI US FDA
  • 15 September 2011 VAI US FDA
  • 9 September 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Dublin, United Arab Emirates Not on file
Ballerup, United Arab Emirates Not on file
Segrate (Milan), United Arab Emirates Not on file
São Paulo, Brazil Not on file
SAO PAULO, Brazil Not on file
Kloten, Switzerland Not on file

9 further sites are on record.

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

Azelaic Acid finished dose Betamethasone finished dose Calcipotriol API Dolutegravir finished dose Fusidic Acid API Heparin API Methylprednisolone finished dose Protamine finished dose Salicylic Acid finished dose Tacrolimus finished dose Tenofovir Alafenamide finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 141 None
EMA 141 5
Health Canada 91 None
MHRA (UK) 62 None
INFARMED (PT) 56 None
MPA (SE) 52 None
ANVISA (Brazil) None 5
US FDA None 2
ZLG (DE) None 2
MFDS (Korea) None 2
NCELS (KZ) None 1
NAFDAC (NG) None 1

Questions about Leo Pharma

Does Leo Pharma hold a US DMF or a CEP?
Leo Pharma holds 2 active US drug master files and 11 valid CEPs. 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 Leo Pharma FDA-registered?
3 sites operated by Leo Pharma 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 Leo Pharma's last inspection go?
The most recent inspection on record closed on 26 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 15 inspections are on file, of which 1 closed as OAI.
Where does Leo Pharma manufacture?
15 registered sites are on record, in United Arab Emirates, Brazil, Switzerland and Denmark (Dublin, Ballerup and Segrate (milan) among others). Every site is listed on this page with the register it came from.
What does Leo Pharma make?
5 molecules are on record against Leo Pharma, including Calcipotriol, Sodium Fusidate, Fusidic Acid and Alfacalcidol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Leo Pharma's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, US FDA, ZLG (DE), MFDS (Korea) and 2 more. 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

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

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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