Ranked API manufacturers
01 Hungary
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for estradiol, filing since 1981. Its GMP is recognised in 28 markets.
Last FDA inspection
Not established
GMP recognised in
28 markets
02 Brazil
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for estradiol, filing since 1978. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 46 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
46 markets
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for estradiol, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
04 Germany
Makes the APIFinished dose
Holds 2 valid CEPs for estradiol, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 22 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
22 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs for estradiol, filing since 2009. 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 estradiol, filing since 2019. 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
Holds one active US DMF for estradiol, filing since 2026. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
08 Netherlands
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs for estradiol, filing since 1980.
Last FDA inspection
Not established
GMP recognised in
Not established
Holds one active US DMF for estradiol, filing since 1992.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for estradiol, filing since 2024. Its 2016 FDA inspection closed as VAI.
Last FDA inspection
2016 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for estradiol, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for estradiol, filing since 2010.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for estradiol, filing since 2026. 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 estradiol, filing since 2026. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · OAI
GMP recognised in
2 markets
Registered with SFDA (Saudi Arabia) for estradiol.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 16 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for estradiol. 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 13 more manufacturers hold filings for estradiol
The names are listed below. Ask Fred about the filings, inspection history and GMP
certificates on record for each manufacturer.
Chat with Fred, your AI analyst Contract manufacturers (7)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (95)
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.