Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Andelyn Biosciences, Inc. | Columbus, OH, United States | Makes it, makes the active ingredient and tests it | Not inspected on record |
| Ultragenyx Pharmaceutical Inc. | Bedford, MA, United States | Makes it | Not inspected on record |
| Ultragenyx Pharmaceutical Inc. | Woburn, MA, United States | Tests it | Not inspected on record |
Product details
- Generic drug
- Rebisufligene Etisparvovec: every company that makes it
- Form
- kit
- Strength
- 10000000000000 {GC} per 1 mL
- Approval
- BLA BLA125845
- On the market since
- Oct 31, 2026
- Package NDCs
69794-300-0169794-329-93- Official label
- DailyMed (National Library of Medicine), updated Oct 1, 2026
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