Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds 6 active US DMFs and 5 valid CEPs for hydrocortisone, filing since 1976. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2021 · VAI
GMP recognised in
2 markets
02 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for hydrocortisone, filing since 2002. 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
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for hydrocortisone, filing since 2016. 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 Brazil
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 46 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
46 markets
05 Germany
Makes the APIFinished dose
Holds one valid CEP for hydrocortisone, 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 hydrocortisone, filing since 2018. 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 5 active US DMFs for hydrocortisone, filing since 2015. 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 3 active US DMFs for hydrocortisone, filing since 2006. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
09 China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 6 active US DMFs for hydrocortisone, filing since 2014. 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 4 active US DMFs for hydrocortisone, filing since 2018. 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 2 active US DMFs for hydrocortisone, filing since 2021. 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
12 United States
Makes the API
Registered with SFDA (Saudi Arabia) for hydrocortisone. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
7 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for hydrocortisone, filing since 2020. 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 one active US DMF for hydrocortisone, filing since 2018. 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 one active US DMF for hydrocortisone, filing since 2017. 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 one active US DMF for hydrocortisone, filing since 2023. 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
Holds one active US DMF for hydrocortisone, filing since 2014. 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 2 valid CEPs for hydrocortisone, filing since 2023. Its 2023 FDA inspection closed as VAI.
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
19 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for hydrocortisone, 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 hydrocortisone, filing since 2016.
Last FDA inspection
Not established
GMP recognised in
Not established
27 more manufacturers hold filings for hydrocortisone
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 (7)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (126)
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.