Pyrimidine Synthesis Inhibitor
Where is Teriflunomide made?
16 companies sell it under their own name and 1 repackager rebottle it. Their labels name 15 factories in India, France, Switzerland, the United Kingdom and Germany.
India 10France 2Switzerland 1United Kingdom 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Genzyme Corporation Aubagio7 mg, 14 mg · NDC 58468-0210, 58468-0211 | Euroapi FranceMakes the active ingredient | Vertolaye, France | No problems foundMar 2024 |
| Micro-Macinazione SaMakes the active ingredient | Monteggio, Switzerland | Problems found, fixed voluntarilyNov 2024 | |
| Opella Healthcare International SasMakes it, tests it, packages it and labels it | Compiegne, France | Problems found, fixed voluntarilyJan 2025 | |
| Penn Pharmaceutical Services LimitedMakes it, tests it, packages it and labels it | Tredegar, United Kingdom | Problems found, fixed voluntarilyApr 2022 | |
| Sanofi-Aventis Deutschland GmbHMakes the active ingredient and tests it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 | |
| Accord Healthcare Inc.7 mg, 14 mg · NDC 16729-400, 16729-399 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Inc.7 mg, 14 mg · NDC 62332-314, 62332-313 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited7 mg, 14 mg · NDC 46708-314, 46708-313 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited7 mg, 14 mg · NDC 59651-055, 59651-054 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Biocon Pharma Inc.7 mg, 14 mg · NDC 70377-018, 70377-017 | Biocon Pharma LimitedMakes it | Bengaluru, India | No problems foundJun 2023 |
| Cadila Healthcare Limited7 mg, 14 mg · NDC 70771-1011, 70771-1010 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Camber Pharmaceuticals Inc.7 mg, 14 mg · NDC 31722-247, 31722-246 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| CivicaScript LLC7 mg, 14 mg · NDC 82249-112, 82249-111 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Concord Biotech Limited7 mg, 14 mg per 14 · NDC 68254-5010, 68254-5013 | Concord Biotech LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Glenmark Pharmaceuticals Inc., USA7 mg, 14 mg · NDC 68462-424, 68462-423 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| MSN Laboratories Private Limited7 mg, 14 mg · NDC 69539-033, 69539-316, 69539-032 +1 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Natco Pharma USA LLC7 mg, 14 mg · NDC 69339-170, 69339-169 | Natco Pharma LimitedMakes it | Rangareddy, India | Problems found, fixed voluntarilyJun 2025 |
| Zydus Pharmaceuticals (USA) Inc.7 mg, 14 mg · NDC 70710-1115, 70710-1114 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Mylan Pharmaceuticals Inc.7 mg, 14 mg · NDC 0378-0628, 0378-0627 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.7 mg, 14 mg · NDC 0480-3156, 0480-3157 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Teriflunomide 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
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.