NDC 71390-011
Byfavo 2.5 mg per 1 mL injection, powder, lyophilized, for solution
On the label: Acacia Pharma, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cambrex Karlskoga AB | Karlskoga, Sweden | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMay 24, 2024 · 5 inspections |
| Cosmo SpA | Lainate, Italy | Makes it and tests it | Problems found, fixed voluntarilyNov 11, 2022 · 5 inspections |
| Patheon Italia S.p.A. | Monza, Italy | Makes it, tests it and packages it | Problems found, fixed voluntarilyMay 26, 2023 · 10 inspections |
| Eurofins BioPharma Product Testing Sweden AB | Uppsala, Sweden | Tests it | Problems found, fixed voluntarilyJun 19, 2024 · 2 inspections |
| ITS Testing Services (UK) Limited | Manchester, United Kingdom | Tests it | Problems found, fixed voluntarilyJan 26, 2024 · 4 inspections |
| Particle Analytical ApS | Hoersholm, Denmark | Tests it | Problems found, fixed voluntarilyJan 9, 2025 · 5 inspections |
Product details
- Generic drug
- Remimazolam: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 2.5 mg per 1 mL
- Approval
- NDA NDA212295
- On the market since
- Oct 6, 2020
- Package NDCs
71390-011-0071390-011-11- Official label
- DailyMed (National Library of Medicine), updated Feb 20, 2025
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