NDC 73441-800
Omisirge 400000000 1 per 50 mL / 800000000 1 per 100 mL kit
On the label: Gamida Cell Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gamida Cell LTD | Kiryat Gat, Israel | Makes it, makes the active ingredient, tests it, packages it and labels it | Not inspected on record |
| Alcami Carolinas Corporation | Wilmington, NC, United States | Tests it | Problems found, fixed voluntarilySep 26, 2025 · 11 inspections |
| Alcami Carolinas Corporation | Durham, NC, United States | Tests it | No problems foundDec 6, 2024 · 4 inspections |
| Aminolab Ltd. | Ness Ziona, Israel | Tests it | Problems found, fixed voluntarilyAug 2, 2022 · 2 inspections |
| Eurofins Biolab Srl | Vimodrone, Italy | Tests it | Problems found, fixed voluntarilySep 13, 2024 · 5 inspections |
| Hy Laboratories Ltd | Rehovot, Israel | Tests it | Problems found, fixed voluntarilyOct 20, 2010 · 1 inspection |
Product details
- Generic drug
- Omidubicel and Omidubicel Non-Cultured Fraction: every company that makes it
- Form
- kit
- Strength
- 400000000 1 per 50 mL / 800000000 1 per 100 mL
- Approval
- BLA BLA125738
- On the market since
- May 1, 2023
- Package NDCs
73441-100-0173441-200-0173441-300-0173441-400-0173441-800-04- Official label
- DailyMed (National Library of Medicine), updated Feb 19, 2026
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