Ranked API manufacturers
01 United States
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for fentanyl, filing since 1993. 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 States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for fentanyl, filing since 2005. Its 2024 FDA inspection closed as NAI.
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
03 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for fentanyl, filing since 2003. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for fentanyl, filing since 2022. 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 Kingdom
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for fentanyl, filing since 2014. 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
06 Belgium
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for fentanyl, filing since 2018. Its GMP is recognised in 7 markets.
Last FDA inspection
Not established
GMP recognised in
7 markets
07 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for fentanyl, filing since 2004. Its 2022 FDA inspection closed as NAI.
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for fentanyl, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
Registered with SFDA (Saudi Arabia) for fentanyl. Its GMP is recognised in 3 markets.
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 10 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for fentanyl, filing since 2005.
Last FDA inspection
Not established
GMP recognised in
Not established
11 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for fentanyl, filing since 1983.
Last FDA inspection
Not established
GMP recognised in
Not established
12 United States
Makes the API
Registered with SFDA (Saudi Arabia) for fentanyl.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 13 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for fentanyl. 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 10 more manufacturers hold filings for fentanyl
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 (5)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (84)
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