Suppliers / Epax Norway

Epax Norway

Norway Updated 9 July 2026

Epax Norway is an API manufacturer based in Norway. It holds one valid CEP. Its GMP standing is certified by EMA.

0
active US DMFs
1
valid CEPs
3
registered plants
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Oslo, Norway Not on file
Aalesund, Norway Not on file
Ålesund, Norway Not on file

What they file, and where

Molecule Regulators Docs
Omega-3 Fatty Acids EDQM 1

Also appears on these molecule pages

Omega-3 Fatty Acids API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Epax Norway

Does Epax Norway hold a US DMF or a CEP?
Epax Norway holds 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.
Where does Epax Norway manufacture?
3 registered sites are on record, in Norway (Oslo, Aalesund and Ålesund). Every site is listed on this page with the register it came from.
What does Epax Norway make?
1 molecule is on record against Epax Norway, including Omega-3 Fatty Acids. Each links through to that molecule's full manufacturer list.
Which regulators recognise Epax Norway's GMP?
Current GMP certificates are on record from 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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Sources on this page

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