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 fulvestrant, filing since 2013. 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
02 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for fulvestrant, filing since 2015. 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 for fulvestrant, filing since 2018. 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 one active US DMF for fulvestrant, filing since 2023.
Last FDA inspection
Not established
GMP recognised in
Not established
2 more manufacturers in Italy hold filings for fulvestrant
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 Fulvestrant 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.