Kinase Inhibitor
Where is Sunitinib made?
8 companies sell it under their own name and 1 repackager rebottle it. Their labels name 8 factories in India, Singapore, Ireland and Italy.
India 5Singapore 1Ireland 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc Sutent12.5 mg, 25 mg, 37.5 mg, 50 mg · NDC 0069-0550, 0069-0770, 0069-0830 +1 | Pfizer Asia Manufacturing Pte LtdMakes the active ingredient and tests it | Singapore, Singapore | Problems found, fixed voluntarilyOct 2023 |
| Pfizer Ireland Pharmaceuticals Unlimited CompanyMakes the active ingredient and tests it | Ringaskiddy, Ireland | Problems found, fixed voluntarilyOct 2024 | |
| Pfizer Italia S.r.l.Makes it, tests it, packages it and labels it | Ascoli Piceno, Italy | Problems found, fixed voluntarilyMar 2025 | |
| Aurobindo Pharma Limited12.5 mg, 25 mg, 37.5 mg, 50 mg · NDC 59651-464, 59651-465, 59651-466 +1 | EUGIA Pharma Specialities LimitedMakes it, tests it and packages it | Medchal-Malkajgiri, India | No problems foundJul 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.12.5 mg, 25 mg, 37.5 mg, 50 mg · NDC 63304-091, 63304-092, 63304-093 +1 | Sun Pharmaceutical Industries LimitedMakes it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Dr. Reddy's Laboratories Inc.12.5 mg, 25 mg, 37.5 mg, 50 mg · NDC 43598-045, 43598-046, 43598-047 +1 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Novadoz Pharmaceuticals LLC12.5 mg, 25 mg, 37.5 mg, 50 mg · NDC 72205-116, 72205-117, 72205-118 +1 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Novugen Pharma (USA) LLC.12.5 mg, 25 mg, 37.5 mg, 50 mg · NDC 82293-014, 82293-015, 82293-016 +1 | Teyro Labs Private LimitedMakes it | Kanchipuram District, India | Problems found, fixed voluntarilyNov 2025 |
| Mylan Pharmaceuticals Inc.12.5 mg, 25 mg, 37.5 mg, 50 mg · NDC 0378-6678, 0378-6679, 0378-6681 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.12.5 mg, 25 mg, 37.5 mg, 50 mg · NDC 0093-8199, 0093-8224, 0093-8229 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Sunitinib 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.
Recalls
- Oct 18, 2024 · Class II · AvKARE · 2 recall notices
Labeling: Label Mix-Up - Jul 5, 2023 · Class II · Teva Pharmaceuticals USA Inc
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.