Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hovione Farmaciencia, S.a. | Loures, Portugal | Makes the active ingredient and tests it | Problems found, fixed voluntarilyOct 24, 2024 · 10 inspections |
| The Ritedose Corporation | Columbia, SC, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 28, 2025 · 12 inspections |
| Instituto de Soldadura E Qualidade | Porto Salvo, Portugal | Tests it | Problems found, fixed voluntarilyMar 22, 2024 · 1 inspection |
| Quality Chemical Laboratories | Wilmington, NC, United States | Tests it | Problems found, fixed voluntarilyNov 20, 2024 · 5 inspections |
| The Ritedose Corporation | Columbia, SC, United States | Packages it and labels it | Problems found, fixed voluntarilyFeb 28, 2025 · 12 inspections |
Product details
- Generic drug
- Ensifentrine: every company that makes it
- Form
- suspension, respiratory (inhalation)
- Strength
- 3 mg per 2.5 mL
- Approval
- NDA NDA217389
- On the market since
- Jun 26, 2024
- Package NDCs
83034-003-0183034-003-0583034-003-6083034-003-65- Official label
- DailyMed (National Library of Medicine), updated Oct 13, 2026
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