Interferon Beta-1B Injection Suppliers & Bulk Manufacturers
Available Forms: Injectable Solution
Available Strengths: 250 mcg
Reference Brands: Betaseron, Extavia(US)
Category: Multiple sclerosis
Interferon Beta-1b injection is available in Injectable Solution and strengths such as 250 mcg. 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, Interferon Beta-1b injection 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) |
Interferon Beta-1b injection 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: Interferon Beta-1b, marketed as Betaseron and Extavia, is approved in the US by the FDA and in the EU via EMA for multiple sclerosis treatment. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trials and manufacturing standards, while the EMA ensures compliance with regional safety and quality requirements. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional regulatory compliance supports the timely approval, safe use, and global availability of Interferon Beta-1b, providing effective MS management worldwide.
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