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

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.

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.