Suppliers / KinOmega Biopharm

KinOmega Biopharm

China Updated 9 July 2026

KinOmega Biopharm is an API manufacturer based in China. It holds 3 active US drug master files and 3 valid CEPs across a filed portfolio of 4 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 24 January 2025 as VAI.

3
active US DMFs
3
valid CEPs
2
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
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 24 January 2025 VAI US FDA

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

Registered plants

Site FDA FEI
Deyang City, China Not on file
China, China 3009754809

What they file, and where

Molecule Regulators Docs
Omega-3-Acid Ethyl Esters 90 EDQM 3
Icosapent US FDA 1
Icosapent Ethyl US FDA 1
Omega-3-Acid Ethyl Esters US FDA 1

Also appears on these molecule pages

Icosapent Ethyl API Omega-3-Acid Ethyl Esters API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1

Questions about KinOmega Biopharm

Does KinOmega Biopharm hold a US DMF or a CEP?
KinOmega Biopharm holds 3 active US drug master files and 3 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 KinOmega Biopharm FDA-registered?
One site operated by KinOmega 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.
How did KinOmega Biopharm's last inspection go?
The most recent inspection on record closed on 24 January 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does KinOmega Biopharm manufacture?
2 registered sites are on record, in China (Deyang City and China). Every site is listed on this page with the register it came from.
What does KinOmega Biopharm make?
4 molecules are on record against KinOmega Biopharm, including Omega-3-Acid Ethyl Esters 90, Icosapent, Icosapent Ethyl and Omega-3-Acid Ethyl Esters. Each links through to that molecule's full manufacturer list.
Which regulators recognise KinOmega Biopharm's GMP?
Current GMP certificates are on record from MFDS (Korea) and US FDA. 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 January 2025.

Comparable suppliers

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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