Molecules / Omega-3 Fatty Acids

Omega-3 Fatty Acids API manufacturers

CAS 329042-31-1 Updated 9 July 2026
5
manufacturers with an active filing 4 of them hold a US DMF or a CEP
85
finished-dose makers across 16 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

BASF

Germany
Makes the API

Holds 2 active US DMFs for omega-3 fatty acids, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
2 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

Epax Norway

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

Holds one valid CEP for omega-3 fatty acids, filing since 2012.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
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03

Kd Pharma Bexbach

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

Holds one active US DMF for omega-3 fatty acids, filing since 2008.

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

Croda International

United Kingdom
Makes the API

Registered with SFDA (Saudi Arabia) for omega-3 fatty acids. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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2 more manufacturers hold filings for omega-3 fatty acids

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

Zhoushan Sinomega Biotech EngineeringCroda International
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Finished-dose makers (7)

Duopharma Manufacturing Bangi Sdn Bhd Malaysia B. Braun Melsungen Germany «B. Braun Medical» Portugal Qingdao Kingway Pharmatech China Aja Pharmaceutical Industries Saudi Arabia Hochster Pharmaceutical Industries Egypt Medcare Portugal

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 fatty acids?

Ask Fred which manufacturers are on record for omega-3 fatty acids and what filings they hold.

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Also on this molecule

Finished dose 7 Contract mfrs 0