Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Cipla Limited | Salcette, India | Makes it and tests it | Problems found, fixed voluntarilyJun 21, 2024 · 12 inspections, 2 with FDA action |
| Cipla Limited | Bengaluru, India | Makes the active ingredient | Problems found, fixed voluntarilyMay 30, 2025 · 4 inspections |
| Genvion Corporation | Winnipeg, Canada | Makes it and tests it | Problems found, fixed voluntarilyJul 28, 2023 · 2 inspections |
Recalls
- Feb 18, 2026 · Class III · Cipla USA, Inc.
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Lots: Lot #: 5GJ0223, Exp 04/30/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nilotinib: every company that makes it
- Form
- capsule, oral
- Strength
- 200 mg
- Approval
- NDA NDA218922
- On the market since
- Jun 18, 2025
- Package NDCs
69097-032-1769097-032-5669097-032-7369097-032-7469097-032-7669097-032-91- Official label
- DailyMed (National Library of Medicine), updated Sep 29, 2026
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?