Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Delpharm Milano SRL | Segrate, Italy | Makes it, tests it and packages it | Problems found, fixed voluntarilyFeb 18, 2022 · 5 inspections |
| Pcas | Aramon, France | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 19, 2021 · 5 inspections |
| Lab-Service SAS | La Roche Vineuse, France | Mills it | Problems found, fixed voluntarilyMar 7, 2025 · 5 inspections |
| PCAS Finland Oy | Turku, Finland | Tests it | Problems found, fixed voluntarilyJan 10, 2024 · 7 inspections |
| Quinta-Analytica s.r.o. | Prague 10, Czech Republic | Tests it | Problems found, fixed voluntarilyMar 6, 2025 · 8 inspections |
Product details
- Generic drug
- Elafibranor: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 80 mg
- Approval
- NDA NDA218860
- On the market since
- Jun 10, 2024
- Package NDCs
15054-0080-1- Official label
- DailyMed (National Library of Medicine), updated Aug 11, 2026
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