Holds 2 active US DMFs and one valid CEP for cladribine, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.
Holds one active US DMF for cladribine, filing since 2004. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 4 markets.
Holds one active US DMF and one valid CEP for cladribine, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds one valid CEP for cladribine, filing since 2024. Its GMP is recognised in 14 markets.
Holds one active US DMF for cladribine, filing since 2010. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Holds 2 active US DMFs for cladribine, filing since 2021. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Holds one active US DMF for cladribine, filing since 1998. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for cladribine, filing since 2017.
Registered with SFDA (Saudi Arabia) for cladribine. 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 cladribine and what filings they hold.
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