Ranked API manufacturers
01 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for norethisterone, filing since 1957. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
02 Brazil
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for norethisterone, 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
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for norethisterone, filing since 2009. 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 4 valid CEPs for norethisterone, 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
05 Hungary
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for norethisterone, filing since 2024. Its GMP is recognised in 28 markets.
Last FDA inspection
Not established
GMP recognised in
28 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for norethisterone, filing since 2011. 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
07 Singapore
Makes the APIFinished dose
Holds 2 active US DMFs for norethisterone, filing since 2021. Its GMP is recognised in 5 markets.
Last FDA inspection
Not established
GMP recognised in
5 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for norethisterone, filing since 2016. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for norethisterone, filing since 2025. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
10 Netherlands
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for norethisterone, filing since 1980.
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 norethisterone, filing since 2026.
Last FDA inspection
Not established
GMP recognised in
Not established
8 more manufacturers hold filings for norethisterone
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 (39)
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 2023. These are export values rather than
contract prices for regulated-market grade material, which are higher.