Kinase Inhibitor
Where is Nilotinib made?
10 companies sell it under their own name. Their labels name 7 factories in India and Canada.
India 6Canada 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.50 mg, 150 mg, 200 mg · NDC 69097-031, 69097-032, 69097-030 | Cipla LimitedMakes it and tests it | Salcette, India | Problems found, fixed voluntarilyJun 2024 |
| Cipla LimitedMakes the active ingredient | Bengaluru, India | Problems found, fixed voluntarilyMay 2025 | |
| Genvion CorporationMakes it and tests it | Winnipeg, Canada | Problems found, fixed voluntarilyJul 2023 | |
| Camber Pharmaceuticals Inc.150 mg, 200 mg · NDC 31722-779, 31722-780 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Dr. Reddy's Laboratories Inc.50 mg, 150 mg, 200 mg · NDC 43598-455, 43598-456, 43598-055 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Novadoz Pharmaceuticals LLC50 mg, 150 mg, 200 mg · NDC 72205-238, 72205-239, 72205-237 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Torrent Pharma, Inc.150 mg, 200 mg · NDC 13668-710, 13668-711 | Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Gandhinagar, India | No problems foundApr 2026 |
| Apotex Corp.50 mg, 150 mg, 200 mg · NDC 60505-3801, 60505-3802, 60505-3803 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.150 mg, 200 mg · NDC 73190-033, 73190-034 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) Danziten71 mg, 95 mg · NDC 24338-154, 24338-155 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Cycle Pharmaceuticals Ltd. Cavhanza60 mg, 80 mg · NDC 70709-191, 70709-192 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Tasigna50 mg, 150 mg, 200 mg · NDC 0078-0592, 0078-0526, 0078-0951 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Feb 18, 2026 · Class III · Cipla USA, Inc. · 2 recall notices
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.