Compare the 16 manufacturers holding an active US Drug Master File for Icatibant API, with DMF numbers and filing years from the FDA's quarterly DMF list.
Directory listing last reviewed October 2026.
16 manufacturers hold an active Type II Drug Master File for IcatibantAPI, taken from the FDA's quarterly DMF list; 14 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 |
|---|---|---|---|
| Bachem Holding AG | Switzerland / USA | 20862 | 2007 |
| Chengdu Shengnuo BiopharmFDA import alert | China | 28496 | 2015 |
| BCN Peptides | Spain (Barcelona) | 29213 | 2015 |
| TAPI (Teva API) / Novetide | Israel / Global | 30476 | 2016 |
| MSN Laboratories | India (Hyderabad) | 30672 | 2016 |
| Biophore India Pharmaceuticals | India (Hyderabad) | 30526 | 2016 |
| Matrix Pharmacorp | India (Hyderabad) | 31260 | 2016 |
| Dr. Reddy's Laboratories | India | 32156 | 2017 |
| Cipla | India (Mumbai) | 32318 | 2018 |
| Sun Pharmaceutical IndustriesFDA import alert | India (Mumbai) | 31550 | 2018 |
| USV Private Limited | India (Mumbai) | 33212 | 2018 |
| Auro Peptides | India (Hyderabad) | 33750 | 2019 |
| Alembic Pharmaceuticals | India (Vadodara) | 34450 | 2020 |
| Fresenius Kabi iPSUM | Germany | 38190 | 2024 |
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 | 29225 | 2015 |
| Jiangsu Hansoh Pharmaceutical Group Co Ltd | 31106 | 2016 |
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