Compare the 5 manufacturers holding an active US Drug Master File for Teduglutide API, with DMF numbers and filing years from the FDA's quarterly DMF list.
Directory listing last reviewed October 2026.
5 manufacturers hold an active Type II Drug Master File for TeduglutideAPI, taken from the FDA's quarterly DMF list; 3 of them are listed in this directory. 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 |
|---|---|---|---|
| ALP Pharm Beijing | China (Beijing) | 35438 | 2020 |
| MSN Laboratories | India (Hyderabad) | 37596 | 2022 |
| Biocon | India (Bengaluru) | 43910 | 2026 |
Not yet listed in this directory, so we have not reviewed them. Names as printed in the FDA DMF list.
| DMF holder | US DMF | Filed |
|---|---|---|
| Ambio Inc | 30583 | 2016 |
| Olon SPA | 43291 | 2026 |
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