Holds 2 active US DMFs and 2 valid CEPs for clarithromycin, filing since 2003. Its 2020 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.
EDQM certificate database
FDA, List of Drug Master Files
Holds 2 active US DMFs and 2 valid CEPs for clarithromycin, filing since 2003. Its 2020 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.
Holds one active US DMF and 2 valid CEPs for clarithromycin, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.
Holds one active US DMF and 2 valid CEPs for clarithromycin, filing since 2020. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF and one valid CEP for clarithromycin, filing since 2007. Its 2024 FDA inspection closed as NAI.
Holds one valid CEP for clarithromycin, filing since 2021. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Holds one active US DMF for clarithromycin, filing since 2020. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.
Holds one active US DMF for clarithromycin, filing since 2011. Its GMP is recognised in 4 markets.
Holds one active US DMF for clarithromycin, filing since 2013. Its GMP is recognised in 1 market.
Holds one valid CEP for clarithromycin, filing since 2013. Its 2025 FDA inspection closed as VAI.
Registered with SFDA (Saudi Arabia) for clarithromycin. Its 2024 FDA inspection closed as NAI.
Registered with SFDA (Saudi Arabia) for clarithromycin. Its GMP is recognised in 3 markets.
Registered with DAV (Vietnam) for clarithromycin. Its GMP is recognised in 1 market.
Registered with DAV (Vietnam) for clarithromycin. Its GMP is recognised in 1 market.
Registered with PMDA (Japan) for clarithromycin.
Registered with SFDA (Saudi Arabia) for clarithromycin.
Registered with SFDA (Saudi Arabia) for clarithromycin.
Registered with DAV (Vietnam) for clarithromycin. Its GMP is recognised in 1 market.
Registered with DAV (Vietnam) for clarithromycin. Its GMP is recognised in 1 market.
Registered with DAV (Vietnam) for clarithromycin. Its GMP is recognised in 1 market.
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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Start for freeFixed-dose combinations containing clarithromycin. Each page leads with the verified API makers of every component.
| Year | Median | Exporters |
|---|---|---|
| 2026 YTD | $205.79 | 9 |
| 2025 | $214.57 | 25 |
| 2024 | $226.79 | 25 |
| 2023 | $232.61 | 26 |
US dollars per kilogram, customs export unit values.