Ranked API manufacturers
01 Switzerland
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for remifentanil, filing since 2013. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 4 markets.
Last FDA inspection
2023 · NAI
GMP recognised in
4 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for remifentanil, filing since 2018. Its GMP is recognised in 6 markets.
Last FDA inspection
Not established
GMP recognised in
6 markets
03 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for remifentanil, filing since 2016. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2024 · NAI
GMP recognised in
3 markets
04 South Africa
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for remifentanil, filing since 2014. 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
05 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for remifentanil, filing since 2020. 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 valid CEP for remifentanil, 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
07 United Kingdom
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for remifentanil, filing since 2024. 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 one valid CEP for remifentanil, filing since 2022. Its 2021 FDA inspection closed as VAI.
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
09 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for remifentanil, filing since 2011.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for remifentanil.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 7 more manufacturers hold filings for remifentanil
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 (3)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (27)
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