NDC 58468-0051
Xenpozyme 4 mg per 1.1 mL injection, powder, lyophilized, for solution
On the label: Genzyme Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Genzyme Corporation | Framingham, MA, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyApr 9, 2026 · 9 inspections, 1 with FDA action |
| Genzyme Ireland Limited | Waterford, Ireland | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections |
| Patheon Biologics LLC | Saint Louis, MO, United States | Makes the active ingredient and tests it | Problems found, fixed voluntarilyNov 20, 2024 · 7 inspections |
| Bionique Testing Laboratories LLC | Saranac Lake, NY, United States | Tests it | No problems foundJan 15, 2026 · 5 inspections |
| Eurofins Biopharma Product Testing Ireland Limited | Ireland | Tests it | Problems found, fixed voluntarilyMay 26, 2023 · 5 inspections |
| Genzyme Corporation | Northborough, MA, United States | Packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
Product details
- Generic drug
- Olipudase Alfa: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 4 mg per 1.1 mL
- Approval
- BLA BLA761261
- On the market since
- Aug 29, 2022
- Package NDCs
58468-0051-1- Official label
- DailyMed (National Library of Medicine), updated Dec 11, 2025
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