Ranked API manufacturers
01 Denmark
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for colistin, filing since 1998. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.
Last FDA inspection
2021 · VAI
GMP recognised in
9 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for colistin, filing since 2025. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for colistin, filing since 2020.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with DAV (Vietnam) for colistin. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for colistin, 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 valid CEP for colistin, filing since 2011.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with DAV (Vietnam) for colistin. 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 Registered with DAV (Vietnam) for colistin. 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 5 more manufacturers hold filings for colistin
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 (14)
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