Ranked API manufacturers
01 Germany
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for methotrexate, filing since 1995. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for methotrexate, filing since 2025. 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 2 active US DMFs and one valid CEP for methotrexate, filing since 1981. 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 methotrexate, filing since 2007. Its 2024 FDA inspection closed as NAI.
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
05 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for methotrexate, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for methotrexate, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for methotrexate, filing since 2024. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for methotrexate, filing since 2012.
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 methotrexate, filing since 2024. Its GMP is recognised in 5 markets.
Last FDA inspection
Not established
GMP recognised in
5 markets
10 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for methotrexate, filing since 2024. Its 2023 FDA inspection closed as NAI.
Last FDA inspection
2023 · NAI
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for methotrexate. 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 SFDA (Saudi Arabia) for methotrexate. 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 9 more manufacturers hold filings for methotrexate
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 (8)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (69)
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