Hyperimmune Globulins Intravenous (Iv) Or Subcutaneous (Sc) Suppliers & Bulk Manufacturers
Available Forms: Intravenous (IV) or Subcutaneous (SC) Solution
Available Strengths: 100 mg/mL or 50 mg/mL
Reference Brands: Tetanus IG (TIG), Varicella Zoster IG, Cytogam,RhoGAM,Hepatitis B Immune Globulin (HBIG)(US)
Category:
Plasma Products
Hyperimmune globulins IV provide passive immunity by supplying concentrated, pathogen-specific antibodies. They neutralize viruses or toxins, prevent infections, and support immune defense in exposed or immunocompromised individuals. Benefits include rapid protection, reduced disease severity, and enhanced immune response during post-exposure prophylaxis or treatment of infectious diseases.
Hyperimmune Globulins Intravenous (IV) or Subcutaneous (SC) is available in Intravenous (IV) or Subcutaneous (SC) Solution
and strengths such as 100 mg/mL or 50 mg/mL.
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, Hyperimmune Globulins Intravenous (IV) or Subcutaneous (SC) is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
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Technical Specifications & Supply Details
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| 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) |
Hyperimmune Globulins Intravenous (IV) or Subcutaneous (SC) 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:
Hyperimmune globulins (IV), such as Cytogam or HBIG, are approved in the US by the FDA and in the EU via EMA for passive immunization against specific diseases like CMV, rabies, and hepatitis B. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed submissions for safety and efficacy, while the EMA ensures compliance with regional quality standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance is essential for timely approval and safe worldwide use, supporting effective disease prevention.
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