NDC 15054-0043
Onivyde 4.3 mg per 1 mL injection, powder, for solution
On the label: Ipsen Biopharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hubei Haosun Pharmaceutical Co., Ltd. | Ezhou, China | Makes the active ingredient | No problems foundAug 1, 2025 · 5 inspections |
| Ipsen Pharma Biotech | Signes, France | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 29, 2024 · 5 inspections |
| ScinoPharm Taiwan, Ltd. | Tainan, Taiwan | Makes the active ingredient | Serious problems, FDA actionJun 23, 2026 · 7 inspections, 1 with FDA action |
| Avista Pharma Solutions, Inc. dba Cambrex | Agawam, MA, United States | Tests it | Problems found, fixed voluntarilyJul 25, 2025 · 6 inspections |
| Boston Analytical Inc dba BA Sciences | Salem, NH, United States | Tests it | No problems foundMar 7, 2023 · 7 inspections |
| Quality Chemical Laboratories | Wilmington, NC, United States | Tests it | Problems found, fixed voluntarilyNov 20, 2024 · 5 inspections |
Product details
- Generic drug
- Irinotecan: every company that makes it
- Form
- injection, powder, for solution, intravenous
- Strength
- 4.3 mg per 1 mL
- Approval
- NDA NDA207793
- On the market since
- Oct 22, 2015
- Package NDCs
15054-0043-1- Official label
- DailyMed (National Library of Medicine), updated Mar 3, 2025
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