Leflunomide Tablets 10 mg, 20 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 10 mg, 20 mg

Reference Brands: Arava(US & EU)

Category: Arthritis

Leflunomide 10 mg and 20 mg film-coated tablets, a disease-modifying antirheumatic drug for rheumatoid and psoriatic arthritis. For importers, distributors, rheumatology clinics and hospital tender buyers.

Product Description:

Leflunomide is a disease-modifying antirheumatic drug. It is converted to its active metabolite, teriflunomide, which inhibits dihydroorotate dehydrogenase, an enzyme activated lymphocytes need to make pyrimidines. Their expansion slows and joint inflammation settles over several weeks. This page covers 10 mg and 20 mg film-coated tablets. The active metabolite stays in the body for weeks to months, which shapes safety planning.

Leflunomide is used for active rheumatoid arthritis in adults and, in Europe, also for active psoriatic arthritis. Some prescribers start with a short loading dose, then continue at 10 mg or 20 mg daily. Liver function, blood counts and blood pressure are monitored, more often in the first months. The drug is teratogenic and is contraindicated in pregnancy. Women need reliable contraception, and because the drug persists, an accelerated washout with colestyramine or activated charcoal is used before a planned pregnancy or after serious toxicity. Combining it with methotrexate needs close liver monitoring.

Sourcing notes. Leflunomide is a prescription-only medicine. Ask for a CTD or ACTD dossier with bioequivalence data and dissolution profiles for both strengths. The tablets are sensitive to moisture, so tightly closed bottles with desiccant or protective blisters are normal, at room temperature. Stability at 30 °C/75% RH supports supply to Zone IVb climates. Each batch should arrive with a CoA, and the supplier file should include the GMP certificate and a CoPP. Patient cards or leaflets on pregnancy risk may be required by your regulator. In the enquiry note the strengths, pack type, count per pack and destination market.