Human normal immunoglobulin (IVIG and SCIG): Privigen, Octagam, Kiovig, Gammagard and Hizentra
M Care Exports supplies human normal immunoglobulin, the originator brands (Privigen, Octagam, Kiovig, Gammagard Liquid, Gamunex-C, Hizentra) and Indian-made lines, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for IVIG or Hizentra, send the brand, concentration, pack size and destination, and we quote against your regulator's registration route.
Also marketed as Flebogamma DIF, HyQvia and Panzyga.
Human normal immunoglobulin exporter and bulk supplier from India.
"We need a partner for IVIG" is a common importer enquiry, and the first question back is always which brand and which route. Intravenous (IVIG) and subcutaneous (SCIG) products are not interchangeable gram for gram, and each brand has its own label. M Care is a merchant-exporter. We quote originator brands and Indian-made lines (for example Plasmaglob, Globucel and Igwok) against your specification, and Indian-made lines are offered only for destinations whose registration accepts them. Because the active substance comes from donated human plasma, the order also depends on the brand's current availability, which we confirm before we quote.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Plasma-derived immunoglobulin (replacement and immunomodulatory therapy), sourced and documented for export.
Human normal immunoglobulin is purified IgG from pooled human plasma. Per the US labels, Privigen (10% liquid, CSL Behring) is indicated for primary humoral immunodeficiency (PI), chronic immune thrombocytopenic purpura in patients aged 15 and over, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Gammagard Liquid (10%, Takeda) is indicated for PI in patients aged 2 and over, multifocal motor neuropathy and CIDP in adults, by the intravenous route, with subcutaneous use for PI only. Octagam 5% (Octapharma) is labelled for PI. Panzyga (10%) is labelled for PI from age 2, and for chronic ITP and CIDP in adults. Hizentra (20%, CSL Behring) is a subcutaneous product for PI from age 2 and for CIDP maintenance in adults. The EU product pages give a wider list: the Kiovig EPAR covers replacement therapy in primary immunodeficiency and other immunodeficiencies, and immunomodulation in primary immune thrombocytopenia, Guillain-Barre syndrome, Kawasaki disease and multifocal motor neuropathy. The EMA page for HyQvia describes a pairing of immunoglobulin with recombinant human hyaluronidase for subcutaneous use.
Active ingredient
Human normal immunoglobulin G (IgG), plasma-derived. Plasma-derived immunoglobulin (replacement and immunomodulatory therapy).
Forms and strengths
5 % (50 mg/mL) solution for intravenous infusion; 10 % (100 mg/mL) solution for infusion; 20 % (200 mg/mL) solution for subcutaneous infusion.
Indications
Human normal immunoglobulin, purified IgG from pooled human plasma, labelled for primary humoral immunodeficiency, chronic immune thrombocytopenia and CIDP, by intravenous or subcutaneous infusion depending on the brand. Supplied as originator brands and Indian-made lines to destinations whose registration accepts them.
Administration
Intravenous, Subcutaneous. Solution for infusion.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are hospital pharmacists and immunology or haematology formulary leads, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. A typical enquiry reads "I'm looking for Privigen 10% in 20 g vials" or "We need a partner for subcutaneous immunoglobulin for a PI programme". Immunoglobulin is a specialist medicine (the EMA's Hizentra page says treatment should be started by a doctor or nurse experienced in weakened immune systems or CIDP), so the buyer wants the exact brand, pack sizes and remaining shelf life at delivery. Registration runs through the destination regulator, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with that route before quoting.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on human normal immunoglobulin.
Four points matter on the ward and in the store room. First, every immunoglobulin label we fetched carries a boxed warning for thrombosis, and the IV labels we fetched (Privigen, Octagam, Gammagard, Panzyga) also warn of renal dysfunction and acute renal failure; the Privigen label notes it contains no sucrose. In at-risk patients the labels call for adequate hydration and the minimum infusion rate practicable. Second, infusion rates are brand-specific. Privigen starts at 0.5 mg/kg/min and increases as tolerated to 8 mg/kg/min for PI, and to 4 mg/kg/min for ITP, while the Octagam 5% PI maintenance rate is 3.33 mg/kg/min. Third, Hizentra is given by pump, in up to 8 sites at least 2 inches apart, and its label lists hyperprolinaemia and IgA deficiency with anti-IgA antibodies as contraindications. Fourth, storage varies by brand, so never assume a class rule. Check each carton, keep Privigen in its original carton to protect it from light, and never freeze.
The documentation pack a regulator actually asks for.
Storage differs by product, which matters for lane planning. Per the US labels, Privigen is stored at up to 25 C for up to 36 months, in its original carton to protect it from light. Hizentra is stored at up to 25 C for up to 30 months. Gammagard Liquid is stored at 2 to 8 C for up to 36 months, or at up to 25 C for up to 24 months, and a vial moved to room temperature is not returned to the fridge. Octagam 5% is 36 months at 2 to 8 C, with storage at up to 25 C permitted within the first 24 months. None may be frozen. Originator holders per the regulator pages: CSL Behring for Privigen and Hizentra, Takeda for Kiovig and Gammagard, Octapharma for Octagam, Grifols for Flebogamma DIF and Gamunex-C. Plasma is the only source for these medicines. In its note on anti-D immunoglobulins, the EMA states that donor numbers are declining, and we confirm availability before we commit to dates. M Care documentation covers batch certificates of analysis, CDSCO export documents and destination-aligned dossier support. The manufacturer's WHO-GMP status is confirmed per line before quoting.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
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The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for human normal immunoglobulin.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Human normal immunoglobulin supply, the specific questions.
What sets the price of Hizentra or IVIG for an importer, and can you quote it?
We do not publish prices. For an importer, the landed price depends on whether you choose an originator brand or an Indian-made line, the brand and concentration, the pack size (for example 5 g to 40 g vials for Privigen), the quantity, your destination's registration route, cold chain or ambient lane, and Incoterms. M Care Exports quotes per destination once you send brand, pack, volume and country.
How is Hizentra infused, and how does it differ from IVIG?
Per the US label, Hizentra is a 20% solution given as a subcutaneous infusion with a pump, in the abdomen, thigh, upper arm or lateral hip, using up to 8 sites at once, at least 2 inches apart. It is supplied in vials and prefilled syringes. IVIG products such as Privigen are given into a vein at a rate that is titrated upward. The two routes have separate labels, so a buyer should specify the route as well as the brand.
What is the Hizentra dose, and how is it set when switching from IVIG?
The US label gives 0.2 g/kg (1 mL/kg) weekly for CIDP maintenance in adults, with an increase to 0.4 g/kg weekly considered if symptoms worsen. For primary immunodeficiency the interval is flexible, from daily up to every 2 weeks. When switching from IVIG, the label calculates the weekly dose as the previous IVIG dose divided by the weeks between doses, multiplied by 1.37. Dosing decisions belong to the prescriber, and we supply against the local label.
What is Hizentra used for?
The US label lists two uses: primary immunodeficiency in adults and paediatric patients aged 2 and over, and maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The EMA's Hizentra page also lists replacement therapy in certain secondary immunodeficiencies alongside primary immunodeficiency and CIDP. Indications differ by region, so the destination label governs what a hospital may order.
What are the side effects of Hizentra, and what are the warnings for IVIG?
Per the Hizentra label, the most common reactions are local infusion-site reactions (swelling, redness, heat, pain, itching), plus headache, diarrhoea, fatigue and back pain. The label has a boxed warning for thrombosis and contraindicates hyperprolinaemia type I or II and IgA deficiency with anti-IgA antibodies and a history of hypersensitivity. The IVIG labels we reviewed, including Privigen, carry boxed warnings for thrombosis, renal dysfunction and acute renal failure.
What is the generic name of Hizentra, and is there a generic or biosimilar?
The generic name is human normal immunoglobulin (EU) or immune globulin subcutaneous (human) 20% liquid (US label). It is made from large pools of human plasma. Neither the US label nor the EMA page describes a generic or biosimilar version; each brand holds its own authorisation, a separate EPAR in the EU and a separate biologics licence in the US. M Care supplies the originator brand and Indian-made lines, and we confirm which one a destination's registration accepts before quoting.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.