Ergotamine Derivative
Where is Dihydroergotamine made?
16 companies sell it under their own name. Their labels name 4 factories in India, Italy and Germany.
India 2Italy 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Advagen Pharma Ltd.4 mg per 1 mL · NDC 72888-096 | Mipharm SpaMakes it | Milano, Italy | Problems found, fixed voluntarilyFeb 2024 |
| Amneal Pharmaceuticals Brekiya1 mg per 1 mL · NDC 64896-509 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Baxter Healthcare Corporation1 mg per 1 mL · NDC 36000-300 | Siegfried Hameln GmbHMakes it, tests it, packages it, labels it and sterilizes it | Hameln, Germany | Problems found, fixed voluntarilyAug 2024 |
| Cipla USA., Inc.4 mg per 1 mL · NDC 69097-503 | Mipharm SpaMakes it, tests it, packages it and labels it | Milano, Italy | Problems found, fixed voluntarilyFeb 2024 |
| Exelan Pharmaceuticals, Inc.4 mg per 1 mL · NDC 76282-680 | Mipharm SpaMakes it, tests it, packages it and labels it | Milano, Italy | Problems found, fixed voluntarilyFeb 2024 |
| Gland Pharma Limited1 mg per 1 mL · NDC 68083-466 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJun 2023 |
| Hikma Pharmaceuticals USA Inc.4 mg per 1 mL · NDC 24201-463 | Mipharm SpaMakes it | Milano, Italy | Problems found, fixed voluntarilyFeb 2024 |
| Oceanside Pharmaceuticals.4 mg per 1 mL · NDC 68682-357 | Mipharm SpaMakes it | Milano, Italy | Problems found, fixed voluntarilyFeb 2024 |
| Somerset Therapeutics, LLC4 mg per 1 mL · NDC 70069-880 | Mipharm SpaMakes it, tests it, packages it and labels it | Milano, Italy | Problems found, fixed voluntarilyFeb 2024 |
| Hikma Pharmaceuticals USA Inc.1 mg per 1 mL · NDC 0143-9151, 0143-9273 | The label doesn't name the factory. Plants this company names for other drugs | ||
| IT3 Medical LLC1 mg per 1 mL · NDC 70529-030 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Impel Pharmaceuticals LLC Trudhesa4 mg per 1 mL · NDC 77530-725 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Milla Pharmaceuticals Inc.1 mg per 1 mL · NDC 71357-013 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Provepharm Inc.1 mg per 1 mL · NDC 81284-411 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Satsuma Pharmaceuticals, Inc. Atzumi5.2 mg · NDC 76978-101 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Trifluent Pharma, Inc.4 mg per 1 mL · NDC 73352-096 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Nov 22, 2024 · Class II · Provepharm Inc.
Discoloration
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.