Holds 2 active US DMFs for afatinib, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.
Holds one active US DMF for afatinib, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.
Holds one active US DMF for afatinib, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.
Holds one active US DMF for afatinib, filing since 2025. Its GMP is recognised in 4 markets.
Holds one active US DMF for afatinib, filing since 2019. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.
Contract manufacturers make to order rather than holding their own filing for this molecule.
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 afatinib and what filings they hold.
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