NDC 61755-062
Otarmeni 30000000000000 {GC} per 1 mL injection, solution
On the label: Regeneron Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Catalent Maryland, Inc. | Harmans, MD, United States | Makes it | Not inspected on record |
| Regeneron Pharmaceuticals, Inc. | Rensselaer, NY, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 22, 2024 · 10 inspections |
| Bioreliance Corporation | Rockville, MD, United States | Tests it | Problems found, fixed voluntarilyJan 29, 2026 · 7 inspections |
| Brammer Bio MA, LLC | Plainville, MA, United States | Tests it | Not inspected on record |
| Charles River Laboratories, Inc. | Malvern, PA, United States | Tests it | No problems foundJan 20, 2026 · 6 inspections |
| Eurofins Lancaster Laboratories, LLC | Lancaster, PA, United States | Tests it | Problems found, fixed voluntarilyAug 26, 2025 · 8 inspections |
| Fisher BioServices Inc. | Frederick, MD, United States | Packages it and labels it | No problems foundJun 28, 2019 · 1 inspection |
| Fisher Clinical Services Inc. | Allentown, PA, United States | Packages it and labels it | No problems foundMay 7, 2026 · 5 inspections |
| Nelson Labs NV | Leuven, Belgium | Tests it | Problems found, fixed voluntarilyApr 30, 2024 · 3 inspections |
| Primera Analytical Solutions Corporation | Cranbury, NJ, United States | Tests it | Problems found, fixed voluntarilyApr 12, 2024 · 3 inspections |
Product details
- Generic drug
- Lunsotogene Parvec: every company that makes it
- Form
- injection, solution, intracochlear
- Strength
- 30000000000000 {GC} per 1 mL
- Approval
- BLA BLA125874
- On the market since
- Apr 23, 2026
- Package NDCs
61755-062-0061755-062-0161755-062-99- Official label
- DailyMed (National Library of Medicine), updated Apr 27, 2026
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