Holds 8 active US DMFs and 2 valid CEPs for ceftriaxone, filing since 2004. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 12 markets.
EDQM certificate database
FDA, List of Drug Master Files
Holds 8 active US DMFs and 2 valid CEPs for ceftriaxone, filing since 2004. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 12 markets.
Holds one active US DMF for ceftriaxone, filing since 2006. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.
Holds one active US DMF and one valid CEP for ceftriaxone, filing since 2004. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Holds one active US DMF and 2 valid CEPs for ceftriaxone, filing since 2003. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Holds one active US DMF for ceftriaxone, filing since 2019. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.
Holds 3 active US DMFs for ceftriaxone, filing since 2010. Its GMP is recognised in 6 markets.
Holds one active US DMF for ceftriaxone, filing since 2016. Its GMP is recognised in 1 market.
Holds one valid CEP for ceftriaxone, filing since 2019. Its GMP is recognised in 1 market.
Holds one valid CEP for ceftriaxone, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Registered with SFDA (Saudi Arabia) for ceftriaxone. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.
Registered with DAV (Vietnam) for ceftriaxone. Its GMP is recognised in 3 markets.
Registered with DAV (Vietnam) for ceftriaxone. Its GMP is recognised in 1 market.
Registered with DAV (Vietnam) for ceftriaxone. Its GMP is recognised in 1 market.
Registered with DAV (Vietnam) for ceftriaxone. Its GMP is recognised in 1 market.
Registered with DAV (Vietnam) for ceftriaxone. Its GMP is recognised in 1 market.
Registered with DAV (Vietnam) for ceftriaxone. Its GMP is recognised in 1 market.
Registered with SFDA (Saudi Arabia) for ceftriaxone. Its 2023 FDA inspection closed as OAI, and its GMP is recognised in 3 markets.
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 ceftriaxone and what filings they hold.
Chat with Fred, your AI analystFixed-dose combinations containing ceftriaxone. Each page leads with the verified API makers of every component.
| Year | Median | Exporters |
|---|---|---|
| 2025 | $95.50 | 14 |
| 2024 | $105.50 | 17 |
| 2023 | $120.00 | 14 |
| 2022 | $125.48 | 16 |
US dollars per kilogram, customs export unit values.