
Cladribine Tablets Suppliers & Bulk Manufacturers
Available Forms: Tablet
Available Strengths: 10 mg
Reference Brands: Mavenclad(US & EU)
Category: Multiple sclerosis
Cladribine tablets is available in Tablet and strengths such as 10 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, Cladribine 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) |
Cladribine 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Product Description: Cladribine tablets, marketed as Mavenclad, are approved in the US by the FDA and in the EU via EMA for relapsing multiple sclerosis (MS). Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical trial and manufacturing data, while the EMA ensures compliance with regional safety, efficacy, and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional compliance is essential for timely approval, safe use, and worldwide availability of cladribine tablets, supporting optimal MS treatment outcomes.
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