Leflunomide Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 10 mg, 20 mg
Reference Brands: Arava(US & EU)
Category:
Arthritis
Leflunomide inhibits dihydroorotate dehydrogenase, blocking pyrimidine synthesis and reducing lymphocyte proliferation. It decreases inflammation and slowing joint damage in rheumatoid arthritis. Benefits include effective symptom control, slowing disease progression, oral convenience, and a favorable safety profile when monitored, making it a valuable disease-modifying agent in RA.
Leflunomide tablets is available in Tablets
and strengths such as 10 mg, 20 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Leflunomide tablets is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Leflunomide tablets can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
Leflunomide tablets are approved in the EU and US for treating rheumatoid arthritis. In the EU, Sanofi’s Arava is regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval is based on extensive clinical data and biosimilarity assessments. Both regions require detailed dossiers for initial approval and ongoing pharmacovigilance. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate efficient market access for leflunomide tablets, ensuring adherence to European and American standards for safe, effective RA management.
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