Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for itraconazole, filing since 2012. 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 active US DMF for itraconazole, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.
Last FDA inspection
2025 · NAI
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 itraconazole, filing since 1997. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2026 · NAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for itraconazole, filing since 2004. 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
Holds 4 valid CEPs for itraconazole, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
06 Belgium
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for itraconazole, filing since 2016. Its GMP is recognised in 7 markets.
Last FDA inspection
Not established
GMP recognised in
7 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for itraconazole, filing since 2011. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 6 markets.
Last FDA inspection
2025 · OAI
GMP recognised in
6 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for itraconazole, filing since 2001. 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
Holds 2 active US DMFs for itraconazole, filing since 2020. 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 itraconazole, filing since 1998. Its 2023 FDA inspection closed as VAI.
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for itraconazole, filing since 2004. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
12 India
Makes the APIFinished dose
Holds one active US DMF for itraconazole, filing since 2013. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for itraconazole, filing since 2022.
Last FDA inspection
Not established
GMP recognised in
Not established
14 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for itraconazole. 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 15 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for itraconazole. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 16 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for itraconazole. 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 17 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for itraconazole. 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 18 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for itraconazole. 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 15 more manufacturers hold filings for itraconazole
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 (7)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (70)
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
- Price band
-
Customs export unit values for 2025. These are export values rather than
contract prices for regulated-market grade material, which are higher.