Prescription drug
Where is Rufinamide made?
11 companies sell it under their own name and 1 repackager rebottle it. Their labels name 13 factories in India, the United States, Belgium, Japan and France.
India 7United States 3Belgium 1Japan 1France 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Eisai Inc. Banzel40 mg per 1 mL, 200 mg, 400 mg · NDC 62856-582, 62856-584, 62856-583 | Ajinomoto OmnichemMakes the active ingredient | Balen, Belgium | Problems found, fixed voluntarilyJun 2025 |
| Bushu Pharmaceuticals, Ltd.Makes it, tests it and packages it | Kodama-gun, Japan | No problems foundNov 2023 | |
| Delpharm HuningueMakes it, tests it, packages it and labels it | Huningue, France | Problems found, fixed voluntarilyNov 2023 | |
| Bionpharma Inc.40 mg per 1 mL · NDC 69452-223 | Corerx, Inc.Makes it | Clearwater, FL, United States | Problems found, fixed voluntarilyFeb 2026 |
| OrBion Pharmaceuticals Private LimitedMakes it and packages it | Kancheepuram, India | No problems foundOct 2025 | |
| Ascend Laboratories, LLC40 mg per 1 mL · NDC 67877-673 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited40 mg per 1 mL, 200 mg, 400 mg · NDC 59651-616, 59651-563, 59651-617 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Camber Pharmaceuticals Inc.40 mg per 1 mL, 200 mg, 400 mg · NDC 31722-598, 31722-688, 31722-599 | Hetero Labs LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Glenmark Pharmaceuticals Inc., USA200 mg, 400 mg · NDC 68462-713, 68462-714 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Hikma Pharmaceuticals USA Inc.40 mg per 1 mL, 200 mg, 400 mg · NDC 0054-0425, 0054-0528, 0054-0426 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Lupin Pharmaceuticals, Inc.40 mg per 1 mL, 100 mg, 200 mg, 400 mg · NDC 68180-802, 68180-803, 68180-797 +1 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Micro Labs Limited200 mg, 400 mg · NDC 42571-391, 42571-392 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Verna, India | Problems found, fixed voluntarilyMay 2025 |
| Northstar Rx LLC.40 mg per 1 mL · NDC 72603-261 | Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 |
| Novadoz Pharmaceuticals LLC40 mg per 1 mL · NDC 72205-038 | MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 |
Repackaged by
These companies buy Rufinamide 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:
60687-824
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations - Jul 21, 2023 · Class II · Aurobindo Pharma USA Inc. · 2 recall notices
cGMP deviations: Batch was released prior to approval. - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.