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
IVIG provides pooled immunoglobulin G (IgG) antibodies, modulating the immune response. It neutralizes pathogens, regulates autoimmune activity, and boosts immune function. Benefits include treating immunodeficiency, autoimmune diseases, and inflammatory conditions, reducing infection risk, improving symptoms, and supporting immune system regulation for better patient outcomes.
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.
|
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) |
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.
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