Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| PCI San Diego, Inc. | San Diego, CA, United States | Makes it and tests it | Problems found, fixed voluntarilyMay 9, 2025 · 11 inspections |
| AMPAC Fine Chemicals LLC | El Dorado Hills, CA, United States | Tests it | No problems foundSep 10, 2025 · 2 inspections |
| AMPAC Fine Chemicals LLC | Rancho Cordova, CA, United States | Tests it | No problems foundSep 10, 2025 · 9 inspections, 1 with FDA action |
| Sharp Clinical Services, LLC | Bethlehem, PA, United States | Packages it and labels it | No problems foundAug 29, 2024 · 6 inspections |
Product details
- Generic drug
- Elamipretide: every company that makes it
- Form
- injection, subcutaneous
- Strength
- 280 mg per 3.5 mL
- Approval
- NDA NDA215244
- On the market since
- Oct 30, 2025
- Package NDCs
72507-800-0472507-800-30- Official label
- DailyMed (National Library of Medicine), updated Dec 10, 2025
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