Ranked API manufacturers
01 United States
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for hydromorphone, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
02 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for hydromorphone, filing since 2008. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
03 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for hydromorphone, filing since 2006. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
04 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for hydromorphone, filing since 2016. Its 2022 FDA inspection closed as NAI.
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for hydromorphone, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
06 United Kingdom
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for hydromorphone, filing since 2017. 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 one valid CEP for hydromorphone, filing since 2022. Its 2023 FDA inspection closed as VAI.
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for hydromorphone. Its GMP is recognised in 6 markets.
Last FDA inspection
Not established
GMP recognised in
6 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with SFDA (Saudi Arabia) for hydromorphone. Its GMP is recognised in 3 markets.
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 10 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for hydromorphone, filing since 2006.
Last FDA inspection
Not established
GMP recognised in
Not established
7 more manufacturers hold filings for hydromorphone
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 Finished-dose makers (27)
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