Benzothiazole
Where is Riluzole made?
6 companies sell it under their own name and 1 repackager rebottle it. Their labels name 5 factories in India, Taiwan and Spain.
India 3Taiwan 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ascend Laboratories, LLC50 mg · NDC 67877-286 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Caraco Pharmaceutical Laboratories, Ltd.50 mg · NDC 62756-538 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Florida Pharmaceutical Products, LLC.50 mg · NDC 69076-200 | Standard Chem. & Pharm. Co., Ltd. Plant IIMakes it | Tainan City, Taiwan | No problems foundNov 2022 |
| Glenmark Pharmaceuticals Inc., USA50 mg · NDC 68462-381 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Italfarmaco S.p.A Tiglutik50 mg per 10 mL · NDC 11797-210 | Italfarmaco S.A.Makes it, tests it and packages it | Alcobendas, Spain | Problems found, fixed voluntarilyJul 2021 |
| Edw Pharma, Inc Tiglutik5 mg per 1 mL, 50 mg per 10 mL · NDC 70726-0304, 70726-0305, 70726-0306 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Riluzole 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.
- AvKARE, Inc.:
42291-775
Recalls
- Oct 20, 2023 · Class II · Itf Pharma Inc
Failed Viscosity Specifications: Out-of-specification test results for viscosity
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.