Belimumab Prefilled Syringe Suppliers & Bulk Manufacturers

Available Forms: Subcutaneous (SC) and intravenous (IV) Prefilled syringe

Available Strengths: 200 mg/ten 1 mL for SQ; 10 mg/mL for IV

Reference Brands: Benlysta(US & EU)

Category: Immune Disorder

Belimumab prefilled syringe is available in Subcutaneous (SC) and intravenous (IV) Prefilled syringe and strengths such as 200 mg/ten 1 mL for SQ; 10 mg/mL for IV. 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, Belimumab prefilled syringe is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Belimumab prefilled syringe 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: Belimumab, marketed as Benlysta, is approved in the US by the FDA and in the EU via EMA for treating active systemic lupus erythematosus (SLE). Regulatory approval requires a comprehensive dossier including clinical trial data, safety profiles, manufacturing processes, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and manufacturing information, while the EMA ensures regional compliance with safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring thorough regulatory compliance is essential for the safe, effective, and timely approval of belimumab prefilled syringe products worldwide, supporting advanced autoimmune disease management.