Compare the 2 manufacturers holding an active US Drug Master File for Setmelanotide API, with DMF numbers and filing years from the FDA's quarterly DMF list.
Directory listing last reviewed October 2026.
2 manufacturers hold an active Type II Drug Master File for SetmelanotideAPI, taken from the FDA's quarterly DMF list. A DMF lets a drug applicant reference the maker's manufacturing data. It is not an FDA approval. Check each manufacturer against the FDA import alert lists before ordering.
| Manufacturer | Location | US DMF | Filed |
|---|---|---|---|
| Chunghwa Chemical Synthesis & Biotech (CCSB) | Taiwan (New Taipei) | 41490 | 2025 |
| Chengdu Shengnuo BiopharmFDA import alert | China | 44372 | 2026 |
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