Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| API, Inc. | Fairfield, NJ, United States | Makes the active ingredient | Problems found, fixed voluntarilyAug 8, 2024 · 5 inspections |
| Frontida BioPharm, LLC | Philadelphia, PA, United States | Makes it, tests it, packages it and labels it | No problems foundApr 2, 2026 · 10 inspections, 1 with FDA action |
| Frontage Laboratories, Inc. | Exton, PA, United States | Tests it | Problems found, fixed voluntarilyJun 18, 2026 · 14 inspections |
| Robertson Microlit Laboratories, Inc. | Ledgewood, NJ, United States | Tests it | No problems foundJan 11, 2024 · 5 inspections |
Product details
- Generic drug
- Dordaviprone: every company that makes it
- Form
- capsule, oral
- Strength
- 125 mg
- Approval
- NDA NDA219876
- On the market since
- Aug 6, 2025
- Package NDCs
68727-250-01- Official label
- DailyMed (National Library of Medicine), updated Aug 8, 2025
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