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Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.
US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.
Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds one active US DMF for icosapent ethyl, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Its 2024 FDA inspection closed as VAI.
Holds one active US DMF for icosapent ethyl, filing since 2023. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for icosapent ethyl, filing since 2020. Its 2023 FDA inspection closed as VAI.
Holds one active US DMF for icosapent ethyl, filing since 2022.
Holds 2 active US DMFs for icosapent ethyl, filing since 2021.
The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.
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.
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