Sphingosine 1-phosphate Receptor Modulator
Where is Fingolimod made?
23 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 16 factories in India, China, the United States and the United Kingdom.
India 12China 2United States 1United Kingdom 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Biocon Pharma Inc.0.5 mg · NDC 70377-019 | Biocon LimitedMakes the active ingredient | Bengaluru, India | Problems found, fixed voluntarilySep 2024 |
| Biocon Pharma LimitedMakes it | Bengaluru, India | No problems foundJun 2023 | |
| Camber Pharmaceuticals Inc.0.5 mg · NDC 31722-889 | Evaric Pharmaceuticals IncMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| Hetero Labs LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2023 | |
| Accord Healthcare Inc.0.5 mg · NDC 16729-342 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Inc.0.5 mg · NDC 62332-228 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Alembic Pharmaceuticals Limited0.5 mg · NDC 46708-228 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | Problems found, fixed voluntarilyMar 2024 |
| Ascend Laboratories, LLC0.5 mg · NDC 67877-476 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited0.5 mg · NDC 65862-952 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Cadila Healthcare Limited0.5 mg · NDC 70771-1603 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Caraco Pharmaceutical Laboratories, Ltd.0.5 mg · NDC 62756-064 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| CivicaScript LLC0.5 mg · NDC 82249-385 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Cycle Pharmaceuticals Ltd. Tascenso ODT0.25 mg, 0.5 mg · NDC 70709-062, 70709-065 | Catalent U.k. Swindon Zydis LimitedMakes it and tests it | Swindon, United Kingdom | Problems found, fixed voluntarilyOct 2024 |
| Dr. Reddy's Laboratories Inc.0.5 mg · NDC 43598-285 | Dr.reddy's Laboratories LimitedMakes it and tests it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Glenmark Pharmaceuticals Inc., USA0.5 mg · NDC 68462-166 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Novadoz Pharmaceuticals LLC0.5 mg · NDC 72205-227 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Quallent Pharmaceuticals Health LLC0.5 mg · NDC 82009-143 | Biocon Pharma LimitedMakes it | Bengaluru, India | No problems foundJun 2023 |
| Rising Pharma Holdings, Inc.0.5 mg · NDC 64980-449 | Sunshine Lake Pharma Co., Ltd.Makes it | Dongguan, China | Problems found, fixed voluntarilyMar 2024 |
| Solco Healthcare U.S., LLC0.5 mg · NDC 43547-003 | Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 |
| XLCare Pharmaceuticals, Inc.0.5 mg · NDC 72865-257 | Evaric Pharmaceuticals IncMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2025 |
| Zydus Pharmaceuticals (USA) Inc.0.5 mg · NDC 68382-912 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Apotex Corp.0.5 mg · NDC 60505-4332 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.5 mg · NDC 0378-4525 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Gilenya0.25 mg, 0.5 mg · NDC 0078-0965, 0078-0607 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.0.5 mg · NDC 0480-7820 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fingolimod 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
- Jul 11, 2023 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.