Ivig (Intravenous Immunoglobulin) Solution 5% , 10% Suppliers & Bulk Manufacturers
Available Forms: Intravenous infusion
Available Strengths: 5% , 10%
Reference Brands: Gammagard (USA), Octagam (EU), Vigam(India)
Category: Immune Disorder
IVIG provides pooled IgG antibodies that modulate immune responses, neutralize pathogens, and regulate autoimmune activity. It helps treat immune deficiencies, autoimmune diseases, and inflammatory disorders. Benefits include rapid immune support, infection prevention, symptom relief, and improved quality of life, making it a vital therapy for immune system regulation.
Product Description:
IVIG (Intravenous Immunoglobulin) solution, marketed as Gammagard or Privigen, is approved in the US by the FDA and in the EU via EMA for passive immunity against specific infections, such as varicella-zoster and other viral diseases. Regulatory approval requires a detailed dossier including clinical efficacy, safety, manufacturing quality, and pharmacovigilance plans. In the US, the FDA rigorously reviews clinical trial and production data, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper compliance is essential for timely approval and safe use of VIG products worldwide, supporting effective infection prevention.
Ivig (Intravenous Immunoglobulin) Solution — third party manufacturing & bulk supply
Ivig (Intravenous Immunoglobulin) Solution 5% , 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 Ivig (Intravenous Immunoglobulin) Solution 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.
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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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