Kinase Inhibitor
Where is Imatinib made?
18 companies sell it under their own name and 5 repackagers rebottle it. Their labels name 8 factories in India, China and the United Kingdom.
India 6China 1United Kingdom 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| BluePoint Laboratories.100 mg, 400 mg · NDC 68001-490, 68001-622, 68001-491 +1 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 | |
| Camber Pharmaceuticals Inc.100 mg, 400 mg · NDC 31722-296, 31722-297 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 | |
| Dr. Reddy's Laboratories Inc.100 mg, 400 mg · NDC 43598-344, 43598-345 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Archis Pharma LLC100 mg, 400 mg · NDC 72819-185, 72819-186 | Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it | Haikou, China | Problems found, fixed voluntarilyMay 2023 |
| Ascend Laboratories, LLC100 mg, 400 mg · NDC 67877-633, 67877-634 | Shilpa Medicare LimitedMakes it | Mahabubnagar, India | Serious problems, FDA actionFeb 2020 |
| Aurobindo Pharma Limited100 mg, 400 mg · NDC 59651-240, 59651-241 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.100 mg, 400 mg · NDC 47335-472, 47335-475 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| CivicaScript LLC100 mg, 400 mg · NDC 82249-020, 82249-021 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Qilu Pharmaceutical Co., Ltd.100 mg, 400 mg · NDC 67184-0532, 67184-0533 | Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it, tests it and packages it | Haikou, China | Problems found, fixed voluntarilyMay 2023 |
| Quallent Pharmaceuticals Health LLC100 mg, 400 mg · NDC 82009-086, 82009-087 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Shorla Oncology Inc. Imkeldi80 mg per 1 mL · NDC 81927-201 | L M Manufacturing LimitedMakes it | Northampton, United Kingdom | Problems found, fixed voluntarilyFeb 2022 |
| Upsher-Smith Laboratories, Inc.100 mg, 400 mg · NDC 0832-0532, 0832-0533 | Qilu Pharmaceutical (Hainan) Co., Ltd.Makes it, tests it and packages it | Haikou, China | Problems found, fixed voluntarilyMay 2023 |
| Apotex Corp.100 mg, 400 mg · NDC 60505-2900, 60505-2901 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Armas Pharmaceuticals Inc.100 mg, 400 mg · NDC 72485-202, 72485-203 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.100 mg, 400 mg · NDC 62135-658, 62135-659 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.100 mg, 400 mg · NDC 0378-2245, 0378-2246 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Gleevec100 mg, 400 mg · NDC 0078-0401, 0078-0649, 0078-1490 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.100 mg, 400 mg · NDC 0093-7629, 0093-7630 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Imatinib in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- American Health Packaging:
60687-882 - Golden State Medical Supply, Inc.:
51407-269,51407-270 - Major Pharmaceuticals:
0904-6901,0904-6621 - Mylan Institutional Inc.:
42292-043,42292-044 - Safecor Health, LLC:
48433-049,48433-050
Recalls
- Feb 17, 2021 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications - Dec 8, 2020 · Class II · Shilpa Medicare Limited · 2 recall notices
CGMP Deviations - Apr 3, 2018 · Class II · Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.