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 treprostinil, filing since 2016. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for treprostinil, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 active US DMFs for treprostinil, filing since 2015. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
04 South Korea
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for treprostinil, filing since 2013. 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 treprostinil, filing since 2016. Its 2019 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2019 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for treprostinil, filing since 2017. Its 2017 FDA inspection closed as NAI.
Last FDA inspection
2017 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for treprostinil, filing since 2014. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for treprostinil, filing since 2011. 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 treprostinil, filing since 2015.
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 treprostinil, filing since 2016.
Last FDA inspection
Not established
GMP recognised in
Not established
Holds one active US DMF for treprostinil, filing since 2021.
Last FDA inspection
Not established
GMP recognised in
Not established
12 United States
Makes the API
Holds 2 active US DMFs for treprostinil, filing since 2016.
Last FDA inspection
Not established
GMP recognised in
Not established
13 South Korea
Makes the API
Registered with SFDA (Saudi Arabia) for treprostinil. 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 more manufacturers hold filings for treprostinil
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)
Centurion Pharma Turkey
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (12)
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