Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for baclofen, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for baclofen, filing since 1988. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for baclofen, filing since 2018. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for baclofen, filing since 2021. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for baclofen, filing since 2023. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
06 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for baclofen, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 14 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
14 markets
07 South Africa
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for baclofen, filing since 1986. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
08 Poland
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for baclofen, filing since 2005. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.
Last FDA inspection
2018 · VAI
GMP recognised in
9 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for baclofen, filing since 1987. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for baclofen, filing since 2005. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
11 Poland
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for baclofen. Its GMP is recognised in 10 markets.
Last FDA inspection
Not established
GMP recognised in
10 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 12 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for baclofen, filing since 2025. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
Registered with SFDA (Saudi Arabia) for baclofen. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 14 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for baclofen. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 15 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for baclofen. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 16 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for baclofen. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with DAV (Vietnam) for baclofen.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 14 more manufacturers hold filings for baclofen
The names are listed below. The filings, inspection history and GMP certificates behind
each one are available with a free account.
Open the full list with a free account Contract manufacturers (3)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (35)
How this list is built
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.
- Active US DMFs
- FDA, List of Drug Master Files
- Valid CEPs
- EDQM certificate database
- Inspection outcomes
- FDA inspection classifications
- GMP certificates
- EudraGMDP and national regulators
- Price band
-
Customs export unit values for 2025. These are export values rather than
contract prices for regulated-market grade material, which are higher.