Ranked API manufacturers
01 China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for dexmedetomidine, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
8 markets
02 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for dexmedetomidine, filing since 2013. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
5 markets
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for dexmedetomidine, filing since 2009. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
04 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for dexmedetomidine, filing since 2009. Its 2024 FDA inspection closed as NAI.
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for dexmedetomidine, filing since 2012. 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 dexmedetomidine, filing since 1998. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for dexmedetomidine, filing since 2021. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for dexmedetomidine, filing since 2023. 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
09 China
Makes the APIFinished dose
Holds one active US DMF for dexmedetomidine, filing since 2024. Its GMP is recognised in 4 markets.
Last FDA inspection
Not established
GMP recognised in
4 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for dexmedetomidine, filing since 2018. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for dexmedetomidine, filing since 2022. 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 for dexmedetomidine, filing since 2024. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
13 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for dexmedetomidine, filing since 2023.
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 dexmedetomidine, filing since 2014.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for dexmedetomidine. Its GMP is recognised in 14 markets.
Last FDA inspection
Not established
GMP recognised in
14 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with SFDA (Saudi Arabia) for dexmedetomidine. Its GMP is recognised in 4 markets.
Last FDA inspection
Not established
GMP recognised in
4 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with SFDA (Saudi Arabia) for dexmedetomidine. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with SFDA (Saudi Arabia) for dexmedetomidine. Its 2022 FDA inspection closed as VAI.
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 16 more manufacturers hold filings for dexmedetomidine
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 (6)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (58)
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