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IVIG (Intravenous Immunoglobulin) solution bulk supplier for pharma manufacturers

IVIG (Intravenous Immunoglobulin) Solution 5% , 10% Suppliers & Bulk Manufacturers

Available Forms: Intravenous infusion

Available Strengths: 5% , 10%

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

Category: Plasma Products

Intravenous immunoglobulin (IVIG) is a purified antibody preparation from donated human plasma, given by infusion for primary immunodeficiency, immune thrombocytopenia (ITP), Guillain-Barré syndrome, Kawasaki disease and other immune conditions. It comes as 5% and 10% solutions; reference products include Gammagard, Octagam and Privigen. 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:

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. 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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

IVIG (Intravenous Immunoglobulin) Solution 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 IVIG (Intravenous Immunoglobulin) Solution listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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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.

Both contain the same antibodies; 10% products deliver the dose in half the volume and are usually infused faster, while 5% products may suit patients who need slower infusion or have kidney or heart concerns.

Primary immunodeficiency (replacement doses) and immune conditions such as ITP, Guillain-Barré syndrome, CIDP and Kawasaki disease (higher immunomodulatory doses).

Depending on the product, at 2–8 °C or at room temperature up to 25 °C; it must not be frozen. Each batch has an official batch release certificate.

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