Fingolimod Capsule Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 0.5 mg
Reference Brands: Gilenya(US)
Category:
Multiple sclerosis
Fingolimod inhibits sphingosine-1-phosphate receptors, trapping lymphocytes in lymph nodes and preventing their migration to the brain and spinal cord. It reduces relapse rates, slows disease progression, and decreases lesion development in multiple sclerosis. Benefits include improved neurological stability, fewer relapses, and enhanced quality of life for MS patients.
Fingolimod Capsule is available in Capsules
and strengths such as 0.5 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, Fingolimod Capsule 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) |
Fingolimod Capsule 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:
Fingolimod capsules, marketed as Gilenya, are approved in the US by the FDA and in the EU via EMA for relapsing-remitting multiple sclerosis (RRMS). Regulatory approval requires a comprehensive dossier including clinical trial data, safety, efficacy, manufacturing processes, and pharmacovigilance plans. In the US, FDA review involves detailed evaluation of clinical and quality data, while the EMA ensures regional compliance with safety and manufacturing standards.
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