Antirheumatic Agent
Where is Leflunomide made?
12 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 8 factories in India, the United States, France and Germany.
India 4United States 2France 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| sanofi-aventis U.S. LLC Arava10 mg, 20 mg, 100 mg · NDC 0088-2160, 0088-2162, 0088-2161 | Opella Healthcare International SasMakes it, tests it, packages it and labels it | Compiegne, France | Problems found, fixed voluntarilyJan 2025 |
| Sanofi-Aventis Deutschland GmbHMakes the active ingredient | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 | |
| Alembic Pharmaceuticals Inc.10 mg, 20 mg · NDC 62332-061, 62332-062 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited10 mg, 20 mg · NDC 46708-436, 46708-437 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited10 mg, 20 mg · NDC 59651-348, 59651-349 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Cadila Healthcare Limited10 mg, 20 mg · NDC 70771-1491, 70771-1492 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.10 mg, 20 mg · NDC 23155-043, 23155-044 | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.Makes it, tests it, packages it and labels it | East Brunswick, NJ, United States | No problems foundSep 2023 |
| KVK-TECH, Inc.10 mg, 20 mg · NDC 10702-277, 10702-278 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Lupin Pharmaceuticals, Inc.10 mg, 20 mg · NDC 70748-129, 70748-130 | Lupin LimitedMakes it and packages it | Dhar, India | Problems found, fixed voluntarilySep 2024 |
| Zydus Pharmaceuticals (USA) Inc.10 mg, 20 mg · NDC 70710-1157, 70710-1158 | Zydus Lifesciences LimitedMakes it and tests it | Solan, India | No problems foundMar 2020 |
| Apotex Corp.10 mg, 20 mg · NDC 60505-2502, 60505-2503 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Burel Pharmaceuticals, LLC10 mg, 20 mg · NDC 35573-447, 35573-448 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.10 mg, 20 mg · NDC 62135-793, 62135-794 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Leflunomide 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.
- A-S Medication Solutions:
50090-5992,50090-7537 - AvKARE, Inc.:
42291-420,42291-421 - AvPAK:
50268-477,50268-478 - Bryant Ranch Prepack:
63629-9728,71335-2874,72162-2409,71335-2403+3 - Dispensing Solutions Inc.:
68258-2992 - NuCare Pharmaceuticals.Inc.:
68071-3763,68071-3764 - Physicians Total Care, Inc.:
54868-6170,54868-2319
Recalls
- Jun 14, 2007 · Class II · Apotex Corp. · 2 recall notices
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.