Intravenous Immunoglobulin (Ivig) Suppliers & Bulk Manufacturers

Available Forms: Intravenous infusion

Available Strengths: 5% and 10%

Reference Brands: Gammagard, Flebogamma, Privigen, Octagam, Kiovig, Carimune(US & EU)

Category: Plasma Products

Intravenous Immunoglobulin (IVIG) is available in Intravenous infusion and strengths such as 5% and 10%. 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, Intravenous Immunoglobulin (IVIG) is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Intravenous Immunoglobulin (IVIG) 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: Intravenous Immunoglobulin (IVIG) injection, marketed as Gammagard, Privigen, Octagam, and others, is approved in the US by the FDA and in the EU via EMA for treating immunodeficiency and autoimmune disorders. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety, manufacturing standards, and pharmacovigilance plans. In the US, the FDA conducts rigorous review, while in the EU, EMA guidelines ensure regional compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory compliance is essential for the safe, effective, and timely approval of IVIG products worldwide, supporting improved patient outcomes across multiple conditions.