Molecules / Omega-3-Acid Ethyl Esters

Omega-3-Acid Ethyl Esters API manufacturers

CAS 308081-97-2 Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
26
finished-dose makers across 6 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

BASF

Germany
Makes the APIFinished dose

Holds one active US DMF for omega-3-acid ethyl esters, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Chemport

South Korea
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for omega-3-acid ethyl esters, filing since 2011. Its 2023 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Croda International

United Kingdom
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for omega-3-acid ethyl esters, filing since 2008. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

KinOmega Biopharm

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for omega-3-acid ethyl esters, filing since 2012. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Shandong Yuwang Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for omega-3-acid ethyl esters, filing since 2020. Its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Công ty cổ phần Korea United Pharm. Int' L

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for omega-3-acid ethyl esters. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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3 more manufacturers hold filings for omega-3-acid ethyl esters

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

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How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

Who makes omega-3-acid ethyl esters?

Ask Fred which manufacturers are on record for omega-3-acid ethyl esters and what filings they hold.

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