Holds one active US DMF for macitentan, filing since 2023. Its 2025 FDA inspection closed as VAI.
US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Holds one active US DMF for macitentan, filing since 2023. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for macitentan, filing since 2017. Its 2024 FDA inspection closed as VAI.
Holds one active US DMF for macitentan, filing since 2024. Its 2025 FDA inspection closed as VAI.
Holds one active US DMF for macitentan, filing since 2025.
Registered with SFDA (Saudi Arabia) for macitentan. Its 2025 FDA inspection closed as VAI.
Registered with SFDA (Saudi Arabia) for macitentan.
The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.
This page filters the worldwide Macitentan manufacturer list to companies based in China. 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. Read the full method.
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