Ranked Italy-based API manufacturers
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
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
04 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
2 more manufacturers in Italy 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 How this list is built
This page filters the worldwide Budesonide manufacturer list to
companies based in Italy. 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.
Read the full method.