Suppliers / Fertin Pharma A/S

Fertin Pharma A/S

Denmark 794 employees Updated 9 July 2026

Fertin Pharma A/S is a finished-dose manufacturer based in Denmark. It holds 2 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with EMA, MPA (SE) and DIGEMAPS (DO). Its GMP standing is certified by ANVISA (Brazil), HSA (SG) and EMA. Its most recent recorded inspection, by US FDA, closed on 4 November 2022 as VAI.

2
active US DMFs
1
valid CEPs
2
registered plants 1 with an FDA FEI number
30
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 4 November 2022 VAI US FDA
  • 10 November 2017 NAI US FDA
  • 20 June 2014 NAI US FDA
  • 27 March 2012 NAI US FDA
  • 24 June 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
VEJLE, Denmark Not on file
Denmark, Denmark 3003029369

What they file, and where

Molecule Regulators Docs
Nicotine US FDA 2
Nicotine Resinate EDQM 1

Also appears on these molecule pages

Nicotine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 12 1
MPA (SE) 7 None
DIGEMAPS (DO) 4 None
ANSM (FR) 4 None
EDA (EG) 2 None
US FDA 1 None
ANVISA (Brazil) None 3
HSA (SG) None 2

Questions about Fertin Pharma A/S

Does Fertin Pharma A/S hold a US DMF or a CEP?
Fertin Pharma A/S holds 2 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 Fertin Pharma A/S FDA-registered?
One site operated by Fertin Pharma A/S 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 Fertin Pharma A/S's last inspection go?
The most recent inspection on record closed on 4 November 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Fertin Pharma A/S manufacture?
2 registered sites are on record, in Denmark (Vejle and Denmark). Every site is listed on this page with the register it came from.
What does Fertin Pharma A/S make?
2 molecules are on record against Fertin Pharma A/S, including Nicotine and Nicotine Resinate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fertin Pharma A/S's GMP?
Current GMP certificates are on record from ANVISA (Brazil), HSA (SG) 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 4 November 2022.

Comparable suppliers

H. Lundbeck A/S also in Denmark Syntese A/S also in Denmark Danipharm A/S also in Denmark H. Lundbecks A/S also in Denmark Novo Nordisk A/S also in Denmark

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