NDC 80203-347
Enjaymo 50 mg per 1 mL injection, solution, concentrate
On the label: Bioverativ Therapeutics Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Biogen MA Inc. | Morrisville, NC, United States | Makes the active ingredient and tests it | No problems foundJun 13, 2018 · 9 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Ravensburg, Germany | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
| Eurofins Biopharma Product Testing Munich GmbH | Planegg, Germany | Tests it | Problems found, fixed voluntarilyJun 23, 2023 · 3 inspections |
| Genzyme Corporation | Northborough, MA, United States | Packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
| KBI Biopharma, Inc. | Durham, NC, United States | Tests it | Problems found, fixed voluntarilyApr 1, 2026 · 5 inspections |
| Sanofi-Aventis Deutschland GmbH | Frankfurt am Main, Germany | Packages it and labels it | Problems found, fixed voluntarilyMar 25, 2022 · 10 inspections, 1 with FDA action |
Product details
- Generic drug
- Sutimlimab: every company that makes it
- Form
- injection, solution, concentrate
- Strength
- 50 mg per 1 mL
- Approval
- BLA BLA761164
- On the market since
- Feb 4, 2022
- Package NDCs
80203-347-01- Official label
- DailyMed (National Library of Medicine), updated Feb 21, 2024
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