NDC 58468-0040
Fabrazyme 5 mg per 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 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 Corporation | Framingham, MA, United States | Makes the active ingredient | Problems found, fixed voluntarilyApr 9, 2026 · 9 inspections, 1 with FDA action |
| 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 |
| Genzyme Corporation | Northborough, MA, United States | Packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
| Genzyme Corporation | Framingham, MA, United States | Tests it | Problems found, fixed voluntarilyApr 9, 2026 · 9 inspections, 1 with FDA action |
Product details
- Generic drug
- Agalsidase Beta: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 5 mg per 1 mL
- Approval
- BLA BLA103979
- On the market since
- Dec 17, 2008
- Package NDCs
58468-0040-1- Official label
- DailyMed (National Library of Medicine), updated Aug 22, 2025
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