Holds one active US DMF and one valid CEP for gadobutrol, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.
Holds one active US DMF and 2 valid CEPs for gadobutrol, filing since 2023. Its 2024 FDA inspection closed as NAI.
Holds one active US DMF for gadobutrol, filing since 1998. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 46 markets.
Holds one active US DMF and one valid CEP for gadobutrol, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds one valid CEP for gadobutrol, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 22 markets.
Holds one active US DMF and one valid CEP for gadobutrol, filing since 2021. Its 2024 FDA inspection closed as VAI.
Holds one active US DMF for gadobutrol, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.
Holds one valid CEP for gadobutrol, filing since 2025. Its 2025 FDA inspection closed as NAI.
Holds one active US DMF for gadobutrol, filing since 2019. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Holds one active US DMF for gadobutrol, filing since 2024. Its GMP is recognised in 5 markets.
Holds one active US DMF for gadobutrol, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds one valid CEP for gadobutrol, filing since 2025.
Holds one valid CEP for gadobutrol, filing since 2025.
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 gadobutrol and what filings they hold.
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