Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| BioSpring Gesellschaft für Biotechnologie mbH | Frankfurt am Main, Germany | Makes the active ingredient and tests it | Problems found, fixed voluntarilyNov 15, 2022 · 2 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Ravensburg, Germany | Makes it and tests it | Problems found, fixed voluntarilyJul 13, 2022 · 10 inspections |
| Genzyme Corporation | Northborough, MA, United States | Tests it, packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
| PPD Development Ireland Ltd. | Athlone, Ireland | Tests it | Problems found, fixed voluntarilyMar 9, 2023 · 4 inspections |
| Sanofi-Aventis Deutschland GmbH | Frankfurt am Main, Germany | Tests it, packages it and labels it | Problems found, fixed voluntarilyMar 25, 2022 · 10 inspections, 1 with FDA action |
| Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Langenargen, Germany | Tests it | Problems found, fixed voluntarilyMar 20, 2024 · 8 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) | Ravensburg, Germany | Tests it | Problems found, fixed voluntarilyJul 27, 2022 · 6 inspections |
| Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Ravensburg, Germany | Tests it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
Product details
- Generic drug
- Fitusiran: every company that makes it
- Form
- injection, solution, subcutaneous
- Strength
- 50 mg per 0.5 mL
- Approval
- NDA NDA219019
- On the market since
- Mar 28, 2025
- Package NDCs
58468-0348-1- Official label
- DailyMed (National Library of Medicine), updated Sep 16, 2025
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