Leflunomide 20mg T
| Product Overview | |
| Generic Name | Leflunomide 20mg T |
| Brand Name(s) | Arava® |
| Product Type | Generic |
| Form | 30 Oral film-coated tablets / comprimidos |
| Strength | 20 mg |
| Therapeutic Class | Pyrimidine synthesis inhibitor; disease-modifying antirheumatic drug. |
| ATC Code | L04AK01 |
| Manufacturing & Regulatory | |
| Manufacturer | Sanofi, Asofarma, Panamfarma |
| Country | France, India, Mexico |
| GMP Compliance | WHO-GMP, PIC/S-GMP |
| DMF/CEP | DMF 42237 and 42418 |
| COFEPRIS | 010.000.4514.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 10 Units |
| Shelf Life | 36 months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW, HS 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | SDS for oral immunosuppressant |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Leflunomide is indicated for adults with active rheumatoid arthritis; some non-U.S. references also include active psoriatic arthritis. Standard maintenance dose is 20 mg once daily. Key safety issues include hepatotoxicity
