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 8 valid CEPs for budesonide, filing since 2014. 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 and 2 valid CEPs for budesonide, filing since 2009. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
3 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for budesonide, filing since 2006. 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
04 Canada
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for budesonide, filing since 2013. 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
05 Sweden
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for budesonide, filing since 2018. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 37 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
37 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for budesonide, filing since 2011. Its 2023 FDA inspection closed as VAI.
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
07 Spain
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for budesonide, filing since 2006. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for budesonide, filing since 2017. Its 2019 FDA inspection closed as VAI.
Last FDA inspection
2019 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for budesonide, filing since 2021. Its 2021 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2021 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for budesonide, filing since 2019. 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 budesonide, filing since 2007. 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
12 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for budesonide, 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
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 valid CEPs for budesonide, filing since 2022. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for budesonide, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for budesonide, filing since 2021. 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
Holds 2 active US DMFs for budesonide, filing since 2025. 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 one valid CEP for budesonide, filing since 2025. Its 2021 FDA inspection closed as VAI.
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for budesonide, filing since 2025. Its 2018 FDA inspection closed as VAI.
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
19 Netherlands
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for budesonide, filing since 1993.
Last FDA inspection
Not established
GMP recognised in
Not established
Holds 2 active US DMFs for budesonide, filing since 2023.
Last FDA inspection
Not established
GMP recognised in
Not established
24 more manufacturers hold filings for budesonide
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 (9)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (62)
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.