Ozanimod Capsules Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 0.92 mg
Reference Brands: Zeposia(US & EU)
Category: Multiple sclerosis
Ozanimod Capsules is available in Capsules and strengths such as 0.92 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, Ozanimod Capsules 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) |
Ozanimod Capsules 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: Ozanimod capsules, marketed as Zeposia, are approved in the US by the FDA and in the EU via EMA for relapsing multiple sclerosis and ulcerative colitis. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing processes, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data, while the EMA ensures compliance with regional standards for safety and manufacturing. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring thorough regional regulatory compliance is crucial for the timely approval, safe use, and global availability of ozanimod capsules, supporting optimal patient outcomes.
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