Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Haupt Pharma Amareg GmbH | Regensburg, Germany | Makes it | Problems found, fixed voluntarilyJul 26, 2024 · 5 inspections |
| Eurofins BioPharma Product Testing ENCO, LLC | Jacksonville, FL, United States | Tests it | Problems found, fixed voluntarilySep 25, 2025 · 2 inspections |
| Pharma Packaging Solutions, LLC | Clinton, TN, United States | Packages it | No problems foundJun 28, 2023 · 4 inspections |
Product details
- Generic drug
- Miltefosine: every company that makes it
- Form
- capsule, oral
- Strength
- 50 mg
- Approval
- NDA NDA204684
- On the market since
- Sep 26, 2026
- Package NDCs
71863-135-28- Official label
- DailyMed (National Library of Medicine), updated Nov 3, 2026
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