Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| F.i.s. Fabbrica Italiana Sintetici S.p.a. | Montecchio Maggiore, Italy | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 6, 2026 · 7 inspections |
| Pharmaceutical Manufacturing Research Services, Inc. | Horsham, PA, United States | Makes it | No problems foundMay 1, 2026 · 7 inspections |
| Shanghai SynTheAll Pharmaceutical Co., Ltd. | Shanghai, China | Makes the active ingredient and tests it | Problems found, fixed voluntarilyApr 25, 2025 · 5 inspections |
| Almac Pharma Services LLC | Audubon, PA, United States | Packages it and labels it | Problems found, fixed voluntarilyAug 22, 2025 · 4 inspections |
Product details
- Generic drug
- Elexacaftor and Ivacaftor and Tezacaftor: every company that makes it
- Form
- kit
- Strength
- 4 ingredients
- Approval
- NDA NDA217660
- On the market since
- Apr 26, 2023
- Package NDCs
51167-445-0151167-545-0751167-645-07- Official label
- DailyMed (National Library of Medicine), updated Jun 22, 2026
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