Holds one active US DMF for difelikefalin, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.
Holds one active US DMF for difelikefalin, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.
Holds one active US DMF for difelikefalin, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.
Holds one active US DMF for difelikefalin, filing since 2025. Its 2024 FDA inspection closed as NAI.
Holds 2 active US DMFs for difelikefalin, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Holds one active US DMF for difelikefalin, filing since 2023. Its 2024 FDA inspection closed as VAI.
Holds one active US DMF for difelikefalin, filing since 2023.
Holds one active US DMF for difelikefalin, filing since 2025.
The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.
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.
Ask Fred which manufacturers are on record for difelikefalin and what filings they hold.
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