Suppliers / Ak Biopharm

Ak Biopharm

South Korea Updated 9 July 2026

Ak Biopharm is an API manufacturer based in South Korea. It holds 2 active US drug master files across a filed portfolio of 2 molecules.

2
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
South, South Korea 3007618030

What they file, and where

Molecule Regulators Docs
Icosapent US FDA 1
Icosapent Ethyl US FDA 1

Also appears on these molecule pages

Icosapent Ethyl API

Questions about Ak Biopharm

Does Ak Biopharm hold a US DMF or a CEP?
Ak Biopharm holds 2 active US drug master files. 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 Ak Biopharm FDA-registered?
One site operated by Ak Biopharm 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.
Where does Ak Biopharm manufacture?
1 registered site is on record, in South Korea (South). Every site is listed on this page with the register it came from.
What does Ak Biopharm make?
2 molecules are on record against Ak Biopharm, including Icosapent and Icosapent Ethyl. Each links through to that molecule's full manufacturer list.

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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Comparable suppliers

Chunghwa Chemical Synthesis & Biotech shares 1 molecule Sichuan Gowell Pharmaceutical shares 1 molecule KinOmega Biopharm shares 1 molecule Finorga shares 1 molecule Kd Pharma Bexbach shares 1 molecule

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