Subcutaneous Immunoglobulin (SCIG) Injection Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 20% solution (200 mg/mL), vials
Reference Brands: Hizentra, Cuvitru (US/EU)
Category: Plasma Products
Subcutaneous immunoglobulin (SCIG) is a concentrated antibody preparation that patients with primary immunodeficiency can infuse under the skin at home, weekly or every two weeks. It gives steadier antibody levels than monthly IVIG. Reference products include Hizentra and Cuvitru (20%). 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:
Subcutaneous Immunoglobulin (SCIG), marketed as Hizentra and Cuvitru, 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. Ensuring compliance is crucial for the safe, effective, and timely approval of SCIG products worldwide, supporting better patient outcomes.
Subcutaneous Immunoglobulin (SCIG) Injection — third party manufacturing & bulk supply
Subcutaneous Immunoglobulin (SCIG) Injection 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:
Indicative minimum order quantity
Subcutaneous Immunoglobulin (SCIG) Injection is supplied as Injection — 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 Subcutaneous Immunoglobulin (SCIG) Injection listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Subcutaneous Immunoglobulin (SCIG) Injec... →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Subcutaneous Immunoglobulin (SCIG) is used to treat patients with primary immunodeficiency disorders and certain immune system deficiencies. It helps strengthen the immune system by providing antibodies that protect the body from infections.
Subcutaneous Immunoglobulin is made from purified human immunoglobulin G (IgG) antibodies obtained from pooled plasma collected from healthy donors.
Common trade names include Hizentra, Cuvitru, HyQvia, Gammanorm, Cutaquig, Xembify, and Subgam.
Several pharmaceutical companies manufacture SCIG products worldwide including CSL Behring, Takeda Pharmaceutical Company, and Grifols.
The generic name is Human Normal Immunoglobulin.
Common brand names include Hizentra, Cuvitru, HyQvia, Gammanorm, Cutaquig, Xembify, and Subgam.
Subcutaneous Immunoglobulin products are manufactured in several countries including the United States, Germany, Austria, and other regions by different plasma-derived pharmaceutical manufacturers.
It can be infused at home, gives steadier antibody levels, and causes fewer systemic reactions than monthly intravenous immunoglobulin.
Weekly or every two weeks, using a small pump. Facilitated SCIG with hyaluronidase (HyQvia) can be given every three to four weeks.
Most 20% products can be stored at room temperature (up to 25 °C) for the shelf life or a defined period; check the product labelling.
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