Ranked API manufacturers
01 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 8 active US DMFs and one valid CEP for cefuroxime, filing since 1991. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs and 2 valid CEPs for cefuroxime, filing since 2003. 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
03 United Kingdom
Makes the API
Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 37 markets.
Last FDA inspection
2026 · NAI
GMP recognised in
37 markets
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs for cefuroxime, filing since 2000. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
05 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for cefuroxime, filing since 2010. 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 cefuroxime, filing since 2021. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
5 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for cefuroxime, filing since 2004. 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 one valid CEP for cefuroxime, filing since 2024. Its GMP is recognised in 5 markets.
Last FDA inspection
Not established
GMP recognised in
5 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for cefuroxime, filing since 2007. Its GMP is recognised in 5 markets.
Last FDA inspection
Not established
GMP recognised in
5 markets
10 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs for cefuroxime, filing since 2008. Its GMP is recognised in 6 markets.
Last FDA inspection
Not established
GMP recognised in
6 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for cefuroxime, filing since 2016. 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 9 active US DMFs for cefuroxime, filing since 2008. Its 2015 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2015 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for cefuroxime, filing since 2026.
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 cefuroxime, filing since 2005. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
Registered with SFDA (Saudi Arabia) for cefuroxime. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
5 markets
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 valid CEP for cefuroxime, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
17 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for cefuroxime. Its GMP is recognised in 3 markets.
Last FDA inspection
Not established
GMP recognised in
3 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 cefuroxime. 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 19 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for cefuroxime. 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 20 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for cefuroxime. 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 26 more manufacturers hold filings for cefuroxime
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 (92)
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.