Holds one active US DMF for nusinersen, filing since 2026. Its GMP is recognised in 14 markets.
Holds 2 active US DMFs for nusinersen, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.
Holds one active US DMF for nusinersen, filing since 2025. Its 2023 FDA inspection closed as NAI.
Holds one active US DMF for nusinersen, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Holds one active US DMF for nusinersen, filing since 2025. Its GMP is recognised in 1 market.
Holds 2 active US DMFs for nusinersen, filing since 2025.
Holds one active US DMF for nusinersen, filing since 2025.
The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.
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.
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