Ranked API manufacturers
01 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for naltrexone, 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
02 United Kingdom
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for naltrexone, filing since 2008. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for naltrexone, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 11 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
11 markets
04 Switzerland
Makes the API
Holds 3 active US DMFs for naltrexone, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
4 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for naltrexone, filing since 2017. Its GMP is recognised in 3 markets.
Last FDA inspection
Not established
GMP recognised in
3 markets
06 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for naltrexone, filing since 2009. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
07 Netherlands
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for naltrexone, filing since 2000.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for naltrexone, filing since 2015.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for naltrexone, filing since 2007.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for naltrexone, filing since 2025.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for naltrexone.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 9 more manufacturers hold filings for naltrexone
The names are listed below. Ask Fred about the filings, inspection history and GMP
certificates on record for each manufacturer.
Chat with Fred, your AI analyst Contract manufacturers (1)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (19)
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.