Ivig (Intravenous Immunoglobulin) Solution Suppliers & Bulk Manufacturers
Available Forms: Intravenous infusion
Available Strengths: 5% or 10%
Reference Brands: Gammagard (Gamunex-C, Flebogamma),Privigen, Octagam, Gamunex-C(US)
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.
IVIG (Intravenous Immunoglobulin) solution is available in Intravenous infusion
and strengths such as 5% or 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, IVIG (Intravenous Immunoglobulin) solution 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) |
IVIG (Intravenous Immunoglobulin) solution 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:
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.
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