Ranked API manufacturers
01 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs for ertapenem, filing since 2015. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 12 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
12 markets
02 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ertapenem, filing since 2018. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ertapenem, filing since 2014. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ertapenem, filing since 2016. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for ertapenem, filing since 2016. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ertapenem, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
07 Taiwan
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for ertapenem. 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
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 08 South Korea
Makes the API
Registered with SFDA (Saudi Arabia) for ertapenem. Its 2023 FDA inspection closed as NAI.
Last FDA inspection
2023 · NAI
GMP recognised in
Not established
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 active US DMF for ertapenem, filing since 2023.
Last FDA inspection
Not established
GMP recognised in
Not established
10 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for ertapenem. 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 7 more manufacturers hold filings for ertapenem
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 (3)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (16)
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