Molecules / Icosapent Ethyl / China

Icosapent Ethyl API manufacturers in China

CAS 86227-47-6 Updated 9 July 2026
5
China-based manufacturers with an active filing of 10 worldwide
Showing 5 of 5 China-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked China-based API manufacturers

01

Zhejiang Medicine

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

Its 2025 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
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

KinOmega Biopharm

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

Holds one active US DMF for icosapent ethyl, filing since 2023. 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
03

Huatai Pharma

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

Holds one active US DMF for icosapent ethyl, filing since 2020. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Sichuan Gowell Pharmaceutical

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

Holds 2 active US DMFs for icosapent ethyl, filing since 2021.

US DMF
2 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
View profile

How this list is built

This page filters the worldwide Icosapent Ethyl manufacturer list to companies based in China. 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. Read the full method.

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All Icosapent Ethyl manufacturers