Holds one active US DMF and 2 valid CEPs for gabapentin, filing since 2005. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
EDQM certificate database
FDA, List of Drug Master Files
Holds one active US DMF and 2 valid CEPs for gabapentin, filing since 2005. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Holds one active US DMF and one valid CEP for gabapentin, filing since 2004. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds one active US DMF and one valid CEP for gabapentin, filing since 2007. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF and one valid CEP for gabapentin, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Holds 4 active US DMFs for gabapentin, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.
Holds 2 active US DMFs for gabapentin, filing since 2012. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Holds one active US DMF and one valid CEP for gabapentin, filing since 2017. Its 2020 FDA inspection closed as VAI.
Holds 2 active US DMFs for gabapentin, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Holds 2 active US DMFs for gabapentin, filing since 2009. Its 2025 FDA inspection closed as NAI.
Holds one active US DMF and one valid CEP for gabapentin, filing since 2022.
Holds one active US DMF and 2 valid CEPs for gabapentin, filing since 2006. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for gabapentin, filing since 2026. Its 2025 FDA inspection closed as NAI.
Holds one active US DMF for gabapentin, filing since 2012. Its 2024 FDA inspection closed as NAI.
Holds one valid CEP for gabapentin, filing since 2018. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Holds one active US DMF for gabapentin, filing since 1999. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds one active US DMF for gabapentin, filing since 2023. Its 2024 FDA inspection closed as VAI.
Holds 2 active US DMFs for gabapentin, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Holds one valid CEP for gabapentin, filing since 2024. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds one active US DMF for gabapentin, filing since 2005. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF and 2 valid CEPs for gabapentin, filing since 2002. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 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 gabapentin and what filings they hold.
Chat with Fred, your AI analyst| Year | Median | Exporters |
|---|---|---|
| 2026 YTD | $30.03 | 18 |
| 2025 | $30.00 | 55 |
| 2024 | $32.50 | 41 |
| 2023 | $38.30 | 36 |
US dollars per kilogram, customs export unit values.