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
Intravenous immunoglobulin (IVIG) 5% and 10% is pooled human antibody given by infusion for primary immunodeficiency, ITP, Guillain-Barré syndrome, CIDP and Kawasaki disease. Reference products include Privigen, Octagam, Kiovig and Gammagard. Supply often depends on plasma availability, so lead times vary; each batch carries a plasma-product release certificate. Ask PharmaTradz for a quote; we confirm the manufacturer, registration documents and lead time for your country.
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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:
Indicative minimum order quantity
Intravenous Immunoglobulin 5% (Ivig) is supplied as Intravenous infusion — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and 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.
Request a quote for Intravenous Immunoglobulin 5% (Ivig) →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
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.
Every batch depends on large volumes of donated plasma, so availability and lead times depend on plasma collection, mainly in the US and Europe.
Slowly, with the rate increased step by step if tolerated, with monitoring for headache, fever, allergic reactions and, rarely, kidney problems or clots.
An official batch release certificate, donor screening and viral safety data, and the certificate of analysis.
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