Fingolimod Capsule Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 0.5 mg
Reference Brands: Gilenya(US)
Category: Multiple sclerosis
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance supports timely approval, safe use, and market availability of fingolimod capsules worldwide, providing critical disease-modifying therapy for MS patients globally.
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