Xanthine Oxidase Inhibitor
Where is Febuxostat made?
19 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 13 factories in India, the United States and China.
India 10United States 2China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Novadoz Pharmaceuticals LLC40 mg, 80 mg · NDC 72205-028, 72205-029 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| MSN Laboratories Private LimitedMakes it and tests it | Rangareddy (District), India | Problems found, fixed voluntarilyJun 2024 | |
| MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 | |
| Alembic Pharmaceuticals Inc.40 mg, 80 mg · NDC 62332-190, 62332-191 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited40 mg, 80 mg · NDC 46708-190, 46708-191 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Ascend Laboratories, LLC40 mg, 80 mg · NDC 67877-668, 67877-669 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited40 mg, 80 mg · NDC 59651-113, 59651-114 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Cadila Healthcare Limited40 mg, 80 mg · NDC 70771-1552, 70771-1553 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Caraco Pharmaceutical Laboratories, Ltd.40 mg, 80 mg · NDC 47335-721, 47335-722 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Dr.Reddy's Laboratories Ltd.40 mg, 80 mg · NDC 55111-796, 55111-797 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Srikakulam, India | Problems found, fixed voluntarilyMay 2022 |
| HEC Pharm USA Inc.40 mg, 80 mg · NDC 72303-0855, 72303-0856 | Sunshine Lake Pharma Co., Ltd.Makes it | Dongguan, China | Problems found, fixed voluntarilyMar 2024 |
| Hikma Pharmaceuticals USA Inc.40 mg, 80 mg · NDC 0054-0413, 0054-0414 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Indoco Remedies Limited40 mg, 80 mg · NDC 14445-156, 14445-157 | Indoco Remedies LimitedMakes it and tests it | Goa, India | Serious problems, FDA actionFeb 2023 |
| Lannett Company, Inc.40 mg, 80 mg · NDC 0527-2244, 0527-2248 | Sunshine Lake Pharma Co., Ltd.Makes it | Dongguan, China | Problems found, fixed voluntarilyMar 2024 |
| Macleods Pharmaceuticals Limited40 mg, 80 mg · NDC 33342-274, 33342-275 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 |
| Major Pharmaceuticals40 mg, 80 mg · NDC 0904-7395, 0904-7396 | MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 |
| Northstar Rx LLC.40 mg, 80 mg · NDC 16714-059, 16714-060 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Viona Pharmaceuticals Inc.40 mg, 80 mg · NDC 72578-136, 72578-137 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Solco Healthcare U.S., LLC40 mg, 80 mg · NDC 43547-295, 43547-296 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Takeda Pharmaceuticals America, Inc. Uloric40 mg, 80 mg · NDC 64764-918, 64764-677 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Tris Pharma Inc40 mg, 80 mg · NDC 27808-206, 27808-207 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Febuxostat 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:
60687-538 - Aphena Pharma Solutions - Tennessee, Inc.:
43353-305,71610-386,71610-411,71610-450+1 - Golden State Medical Supply, Inc.:
51407-293,51407-294 - Major Pharmaceuticals:
0904-7484,0904-7485 - NuCare Pharmaceuticals.Inc.:
68071-5271,68071-3760,68071-3761 - Rebel Distributors Corp..:
21695-516 - Remedyrepack Inc.:
70518-4626
Recalls
- Mar 4, 2024 · Class II · Sun Pharmaceutical Industries Inc · 2 recall notices
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. - Jan 25, 2024 · Class II · Amerisource Health Services LLC
CGMP Deviations - Jan 18, 2024 · Class II · Sun Pharmaceutical Industries Inc · 2 recall notices
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.