Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Petnet Solutions, Inc. | Knoxville, TN, United States | Makes it | No problems foundSep 22, 2026 · 3 inspections |
| Pharmalogic New York City, LLC | Bronx, NY, United States | Makes it | Serious problems, FDA actionAug 19, 2026 · 1 inspection, 1 with FDA action |
| SOFIE Co. dba SOFIE | Sanford, FL, United States | Makes it | Problems found, fixed voluntarilyJan 22, 2024 · 4 inspections, 2 with FDA action |
Product details
- Generic drug
- Piflufolastat F-18: every company that makes it
- Form
- injection, intravenous
- Strength
- 120 mCi per 1 mL
- Approval
- NDA NDA220089
- On the market since
- Jul 1, 2026
- Package NDCs
85347-001-01- Official label
- DailyMed (National Library of Medicine), updated Jul 1, 2026
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