Intravenous Immunoglobulin 5% (Ivig) 5% and 10% 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.
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.
Intravenous Immunoglobulin 5% (Ivig) — third party manufacturing & bulk supply
Intravenous Immunoglobulin 5% (Ivig) 5% and 10% is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Intravenous Immunoglobulin 5% (Ivig) listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Intravenous Immunoglobulin 5% (Ivig) →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Intravenous Immunoglobulin (IVIG) is used to treat various immune deficiency disorders, autoimmune diseases, and inflammatory conditions. It is commonly used in primary immunodeficiency, immune thrombocytopenic purpura (ITP), Kawasaki disease, Guillain-Barré syndrome, and certain neurological disorders.
Intravenous Immunoglobulin is made from purified human immunoglobulin G (IgG) antibodies extracted from pooled human plasma collected from healthy donors.
Common trade names include Gammagard, Privigen, Gamunex-C, Flebogamma, Octagam, Kiovig, Intratect, and Vigam.
Several pharmaceutical companies manufacture IVIG products worldwide including CSL Behring, Grifols, and Takeda Pharmaceutical Company.
The generic name is Human Normal Immunoglobulin.
Common brand names include Gammagard, Privigen, Gamunex-C, Flebogamma, Octagam, Kiovig, Intratect, and Vigam.
Intravenous Immunoglobulin products are manufactured in several countries including the United States, Germany, Spain, Austria, and other regions by different plasma-derived pharmaceutical manufacturers.
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