Ranked 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 2015. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for fulvestrant, filing since 2020. 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 fulvestrant, filing since 2017. Its 2024 FDA inspection closed as NAI.
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs for fulvestrant, filing since 2015. Its 2022 FDA inspection closed as NAI.
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for fulvestrant, filing since 2016. Its 2024 FDA inspection closed as NAI.
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
08 China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for fulvestrant, filing since 2019. Its GMP is recognised in 4 markets.
Last FDA inspection
Not established
GMP recognised in
4 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for fulvestrant, filing since 2009. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2022 · NAI
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 2024. 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 valid CEP for fulvestrant, filing since 2024. 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 active US DMF for fulvestrant, filing since 2015. 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 active US DMF for fulvestrant, filing since 2023.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for fulvestrant. Its 2022 FDA inspection closed as VAI.
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 12 more manufacturers 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 Contract manufacturers (4)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (52)
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