Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Samsung Biologics Co., Ltd. | Incheon, South Korea | Makes the active ingredient | Problems found, fixed voluntarilySep 1, 2023 · 3 inspections |
| Farmaceutici Formenti Spa | Origgio, Italy | Packages it and labels it | Problems found, fixed voluntarilySep 15, 2022 · 1 inspection |
Product details
- Generic drug
- Denosumab: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 60 mg per 1 mL
- Approval
- BLA BLA761392
- On the market since
- Oct 10, 2025
- Package NDCs
83457-012-10- Official label
- DailyMed (National Library of Medicine), updated Nov 11, 2025
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