Ranked API manufacturers
01 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for cisplatin, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for cisplatin, filing since 2010. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 7 markets.
Last FDA inspection
2025 · NAI
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 cisplatin, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 valid CEPs for cisplatin, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for cisplatin, filing since 1986. Its 2022 FDA inspection closed as VAI.
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for cisplatin, filing since 2014. Its 2018 FDA inspection closed as VAI.
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
07 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for cisplatin, filing since 1992.
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 cisplatin, filing since 2024. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
Registered with SFDA (Saudi Arabia) for cisplatin. 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 10 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Its 2025 FDA inspection closed as OAI.
Last FDA inspection
2025 · OAI
GMP recognised in
Not established
7 more manufacturers hold filings for cisplatin
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 (4)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (48)
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