Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| BIPSO GmbH | Singen (Hohentwiel), Germany | Makes it | Problems found, fixed voluntarilyMay 4, 2022 · 5 inspections |
| Guerbet | Lanester, France | Makes the active ingredient | Problems found, fixed voluntarilyApr 26, 2024 · 2 inspections |
| Liebel-Flarsheim Company LLC | Raleigh, NC, United States | Makes it, packages it and labels it | Serious problems, FDA actionApr 8, 2025 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Gadopiclenol: every company that makes it
- Form
- injection, intravenous
- Strength
- 485.1 mg per 1 mL
- Approval
- NDA NDA216986
- On the market since
- Sep 21, 2022
- Package NDCs
67684-4232-167684-4232-2- Official label
- DailyMed (National Library of Medicine), updated Feb 22, 2026
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