Holds one active US DMF and one valid CEP for labetalol, filing since 2019. Its 2019 FDA inspection closed as NAI.
US DMF
1 active
CEP
1 valid
Last FDA inspection
2019 · NAI
GMP recognised in
Not established
Holds one active US DMF and one valid CEP for labetalol, filing since 2019. Its 2019 FDA inspection closed as NAI.
Holds 2 active US DMFs and one valid CEP for labetalol, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Holds one active US DMF and one valid CEP for labetalol, filing since 1995. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Holds one active US DMF and one valid CEP for labetalol, filing since 2022. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for labetalol, filing since 2020. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Holds one active US DMF and one valid CEP for labetalol, filing since 2002. Its 2023 FDA inspection closed as VAI.
Holds one active US DMF for labetalol, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.
Holds 2 active US DMFs for labetalol, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Holds one active US DMF for labetalol, filing since 2010. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Holds 2 active US DMFs for labetalol, filing since 1997. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Holds 2 active US DMFs for labetalol, filing since 2000. Its 2022 FDA inspection closed as VAI.
Holds one active US DMF for labetalol, filing since 1994. Its 2022 FDA inspection closed as VAI.
Holds one active US DMF for labetalol, filing since 2021.
Registered with SFDA (Saudi Arabia) for labetalol. Its GMP is recognised in 1 market.
Registered with SFDA (Saudi Arabia) for labetalol.
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 labetalol and what filings they hold.
Chat with Fred, your AI analyst| Year | Median | Exporters |
|---|---|---|
| 2025 | $200.00 | 9 |
| 2024 | $159.39 | 13 |
| 2023 | $178.33 | 11 |
| 2022 | $182.26 | 10 |
US dollars per kilogram, customs export unit values.