Ranked API manufacturers
01 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for ezetimibe, filing since 2015. 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 2 active US DMFs for ezetimibe, filing since 2025. Its 2020 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.
Last FDA inspection
2020 · NAI
GMP recognised in
15 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for ezetimibe, filing since 2014. 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
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for ezetimibe, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
05 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs for ezetimibe, filing since 2008. 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
06 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ezetimibe, filing since 2016. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
07 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ezetimibe, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
08 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ezetimibe, filing since 2024. Its GMP is recognised in 21 markets.
Last FDA inspection
Not established
GMP recognised in
21 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 6 active US DMFs for ezetimibe, filing since 2006. 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 for ezetimibe, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
11 Czech Republic
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for ezetimibe. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 40 markets.
Last FDA inspection
2024 · NAI
GMP recognised in
40 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 active US DMF for ezetimibe, filing since 2016. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs for ezetimibe, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for ezetimibe, 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 6 active US DMFs for ezetimibe, filing since 2010. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ezetimibe, filing since 2021. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ezetimibe, filing since 2011. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for ezetimibe. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · 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 4 active US DMFs for ezetimibe, filing since 2022.
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 ezetimibe, filing since 2025.
Last FDA inspection
Not established
GMP recognised in
Not established
31 more manufacturers hold filings for ezetimibe
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 (6)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (70)
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.