Subcutaneous Immunoglobulin (Scig) Injection Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 20%, 10 mL/ampoule
Reference Brands: Hizentra, Cuvitru, Vivaglobulin(US)
Category:
Plasma Products
SCIG provides pooled IgG antibodies directly into the tissue, boosting immune defense. It neutralizes pathogens, modulates immune responses, and reduces autoimmune activity. Benefits include convenient home administration, sustained antibody levels, fewer systemic side effects, improved quality of life, and consistent immune support in patients with immunodeficiency or autoimmune conditions.
Subcutaneous Immunoglobulin (SCIG) injection is available in Injection
and strengths such as 20%, 10 mL/ampoule.
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, Subcutaneous Immunoglobulin (SCIG) injection 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) |
Subcutaneous Immunoglobulin (SCIG) injection 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:
Subcutaneous Immunoglobulin (SCIG), marketed as Hizentra, Cuvitru, and Vivaglobulin, is approved in the US by the FDA and in the EU via EMA for primary immunodeficiency and autoimmune diseases. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, FDA review involves detailed assessment of clinical trials and manufacturing standards, while the EMA ensures compliance with regional quality and safety requirements. For expert guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance is crucial for the safe, effective, and timely approval of SCIG products worldwide, supporting better patient outcomes.
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