Suppliers / Fermion

Fermion

Finland 172 employees reconciled across 5 public records · 2 entities Updated 9 July 2026

Fermion is an API and finished-dose manufacturer based in Finland. It holds 32 active US drug master files and 23 valid CEPs. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 24 November 2023 as VAI.

32
active US DMFs
23
valid CEPs
5
registered plants 3 with an FDA FEI number
6
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
8 of 8 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

  • 24 November 2023 VAI US FDA
  • 17 March 2023 VAI US FDA
  • 31 January 2023 NAI US FDA
  • 12 February 2020 VAI US FDA
  • 14 September 2018 VAI US FDA
  • 8 December 2017 VAI US FDA
  • 10 June 2016 VAI US FDA
  • 3 June 2016 VAI US FDA
  • 14 March 2014 VAI US FDA
  • 13 December 2013 NAI US FDA
  • 17 June 2011 NAI US FDA
  • 16 June 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Espoo, Finland Not on file
Finland, Finland 3002807817
Finland, Finland 3003491490
Finland, Finland 3003340711
Oulu, Finland Not on file

What they file, and where

Molecule Regulators Docs
Methotrexate EDQM, SFDA (Saudi Arabia), US FDA 5
Budesonide EDQM 4
Carbidopa EDQM, SFDA (Saudi Arabia), US FDA 4
Azathioprine EDQM, SFDA (Saudi Arabia), US FDA 3
Dexmedetomidine SFDA (Saudi Arabia), US FDA 3
Mercaptopurine EDQM, SFDA (Saudi Arabia), US FDA 3
Quetiapine EDQM, US FDA 3
Alprazolam EDQM, US FDA 2
Buspirone EDQM, US FDA 2
Entacapone EDQM, US FDA 2
Show all 36 molecules on file
Fluoxetine EDQM, US FDA 2
Flutamide EDQM, US FDA 2
Formoterol EDQM, US FDA 2
Hydroxychloroquine EDQM, US FDA 2
Irinotecan EDQM, US FDA 2
Nintedanib US FDA 2
Nitrofurantoin US FDA 2
Propafenone EDQM, US FDA 2
Trazodone SFDA (Saudi Arabia), US FDA 2
B Irone SFDA (Saudi Arabia) 1
Benserazide EDQM 1
Cabozantinib US FDA 1
Cromoglicic Acid US FDA 1
Diltiazem US FDA 1
Fluticasone Propionate EDQM 1
Glipizide US FDA 1
Levosimendan US FDA 1
Methotrexate Disodium SFDA (Saudi Arabia) 1
Nadolol US FDA 1
Ospemifene US FDA 1
Salmeterol EDQM 1
Sodium Cromoglicate EDQM 1
Sodium Cromoglicic Acid SFDA (Saudi Arabia) 1
Tolnaftate US FDA 1
Toremifene US FDA 1
Treosulfan US FDA 1

Also appears on these molecule pages

Alprazolam contract manufacturing Azathioprine contract manufacturing Benserazide contract manufacturing Budesonide API Buspirone contract manufacturing Cabozantinib API Carbidopa contract manufacturing Cromoglicic Acid API Darolutamide finished dose Dexmedetomidine API Diltiazem contract manufacturing Entacapone API
Show 17 more molecule pages
Fluoxetine API Fluticasone API Formoterol contract manufacturing Glipizide contract manufacturing Hydroxychloroquine contract manufacturing Irinotecan contract manufacturing Methotrexate contract manufacturing Nadolol contract manufacturing Nintedanib API Nitrofurantoin contract manufacturing Ospemifene API Propafenone contract manufacturing Quetiapine contract manufacturing Salmeterol API Sodium Cromoglicate API Tamsulosin contract manufacturing Trazodone contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 6 None
US FDA None 1
EMA None 1

Questions about Fermion

Does Fermion hold a US DMF or a CEP?
Fermion holds 32 active US drug master files and 23 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 Fermion FDA-registered?
3 sites operated by Fermion 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 Fermion's last inspection go?
The most recent inspection on record closed on 24 November 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 13 inspections are on file.
Where does Fermion manufacture?
5 registered sites are on record, in Finland (Espoo, Finland and Oulu among others). Every site is listed on this page with the register it came from.
What does Fermion make?
36 molecules are on record against Fermion, including Methotrexate, Budesonide, Carbidopa and Azathioprine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fermion's GMP?
Current GMP certificates are on record from US FDA 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 24 November 2023.

Comparable suppliers

Olon shares 8 molecules Cipla shares 6 molecules MSN Laboratories shares 5 molecules Hetero shares 5 molecules Matrix Pharmacorp shares 5 molecules

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