Ranked API manufacturers
01 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for naloxone, filing since 1972. 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 naloxone, filing since 2007. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for naloxone, filing since 2019. Its 2023 FDA inspection closed as VAI.
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for naloxone, filing since 2024. 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
05 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs for naloxone, filing since 2011. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for naloxone, filing since 2025. Its 2021 FDA inspection closed as VAI.
Last FDA inspection
2021 · 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 naloxone, filing since 1999.
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 naloxone, filing since 2009.
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 naloxone. 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 11 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for naloxone. 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 8 more manufacturers hold filings for naloxone
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 (1)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (59)
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