Ranked API manufacturers
01 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for betamethasone, filing since 2005. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 14 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
14 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for betamethasone, filing since 2003. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for betamethasone, filing since 2016. 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
04 Brazil
Makes the APIFinished dose
Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
5 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs for betamethasone, filing since 2021. Its 2021 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2021 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for betamethasone, filing since 2007. Its 2015 FDA inspection closed as NAI.
Last FDA inspection
2015 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for betamethasone, filing since 2010. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for betamethasone, filing since 1997. 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 6 active US DMFs for betamethasone, filing since 2008. 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 4 active US DMFs for betamethasone, filing since 1986. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs for betamethasone, filing since 2003. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for betamethasone, filing since 2021. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
13 India
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for betamethasone. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2026 · NAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for betamethasone, filing since 2023.
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 betamethasone, filing since 2013.
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 betamethasone, filing since 2022.
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 betamethasone, filing since 2023.
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 betamethasone, filing since 2026.
Last FDA inspection
Not established
GMP recognised in
Not established
19 India
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for betamethasone. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 20 Spain
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for betamethasone. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 32 more manufacturers hold filings for betamethasone
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 (9)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (138)
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.