Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for tamoxifen, filing since 1983. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for tamoxifen, filing since 1986. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for tamoxifen, filing since 2025. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Holds one active US DMF for tamoxifen, 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 2 valid CEPs for tamoxifen, filing since 2022. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
2 more manufacturers hold filings for tamoxifen
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 (1)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (28)
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