Ranked API manufacturers
01 Japan
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for doxorubicin, filing since 1998. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 11 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
11 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for doxorubicin, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for doxorubicin, filing since 2016.
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 doxorubicin, filing since 1998. Its 2026 FDA inspection closed as VAI.
Last FDA inspection
2026 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for doxorubicin, filing since 2002.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for doxorubicin, filing since 2024. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
07 South Korea
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for doxorubicin, filing since 2017. Its GMP is recognised in 5 markets.
Last FDA inspection
Not established
GMP recognised in
5 markets
Registered with SFDA (Saudi Arabia) for doxorubicin. 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 09 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for doxorubicin. 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 6 more manufacturers hold filings for doxorubicin
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 (52)
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