Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for ursodeoxycholic acid, 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
02 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 5 valid CEPs for ursodeoxycholic acid, filing since 2003. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2022 · VAI
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 ursodeoxycholic acid, filing since 1995. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for ursodeoxycholic acid, filing since 2024. 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
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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for ursodeoxycholic acid, filing since 1978. 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 valid CEPs for ursodeoxycholic acid, filing since 2020.
Last FDA inspection
Not established
GMP recognised in
Not established
08 South Korea
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 valid CEPs for ursodeoxycholic acid, filing since 2011. 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
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 and one valid CEP for ursodeoxycholic acid, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
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 one active US DMF for ursodeoxycholic acid, filing since 2017. 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
Its GMP is recognised in 5 markets.
Last FDA inspection
Not established
GMP recognised in
5 markets
Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
Registered with DAV (Vietnam) for ursodeoxycholic acid. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for ursodeoxycholic acid, filing since 2026.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with DAV (Vietnam) for ursodeoxycholic acid. 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 ursodeoxycholic acid. 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
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 ursodeoxycholic acid. 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 32 more manufacturers hold filings for ursodeoxycholic acid
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 Finished-dose makers (38)
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.