Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxalta Us Inc. | Thousand Oaks, CA, United States | Makes it, packages it and labels it | Not inspected on record |
| Takeda Manufacturing Singapore Pte. Ltd. | Singapore, Singapore | Makes the active ingredient and tests it | Not inspected on record |
| OFI Technologie & Innovation GmbH | Vienna, Austria | Tests it | Problems found, fixed voluntarilyOct 3, 2018 · 1 inspection |
| Takeda Manufacturing Austria AG | Wien, Austria | Tests it | Not inspected on record |
| Takeda Manufacturing Austria AG | Orth an der Donau, Austria | Tests it | No problems foundApr 24, 2024 · 1 inspection |
Product details
- Generic drug
- Coagulation Factor Ix Recombinant Human: every company that makes it
- Form
- kit
- Strength
- 250 [iU] per 5 mL
- Approval
- BLA BLA125446
- On the market since
- Oct 4, 2013
- Package NDCs
0944-3025-010944-3026-0264764-515-50- Official label
- DailyMed (National Library of Medicine), updated May 12, 2026
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