Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for ethinylestradiol, filing since 2007. 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
02 Hungary
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 valid CEPs for ethinylestradiol, filing since 2019. Its GMP is recognised in 28 markets.
Last FDA inspection
Not established
GMP recognised in
28 markets
03 Brazil
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ethinylestradiol, filing since 1972. 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
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for ethinylestradiol, filing since 2019. 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
05 Germany
Makes the APIFinished dose
Holds one valid CEP for ethinylestradiol, 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
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 valid CEP for ethinylestradiol, filing since 2026. Its 2017 FDA inspection closed as NAI.
Last FDA inspection
2017 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
09 Netherlands
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Last FDA inspection
Not established
GMP recognised in
Not established
11 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for ethinylestradiol. 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 8 more manufacturers hold filings for ethinylestradiol
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 (2)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (57)
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