Holds one active US DMF for lurbinectedin, filing since 2019. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.
Holds one active US DMF for lurbinectedin, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.
Holds 2 active US DMFs for lurbinectedin, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.
Holds one active US DMF for lurbinectedin, filing since 2023. Its 2024 FDA inspection closed as NAI.
Holds one active US DMF for lurbinectedin, filing since 2024. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for lurbinectedin, filing since 2026. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for lurbinectedin, filing since 2023. Its GMP is recognised in 1 market.
Holds one active US DMF for lurbinectedin, filing since 2024.
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 lurbinectedin and what filings they hold.
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