Nipocalimab-Aah Suppliers & Bulk Manufacturers
Available Forms: Infusion
Available Strengths: 300 mg/1.62 mL, 1200 mg/6.5 m
Reference Brands: Imaavy (USA/EU)
Category: Neurology
Nipocalimab-aahu is a fully human IgG1 monoclonal antibody that blocks the neonatal Fc receptor (FcRn), reducing circulating IgG and harmful autoantibodies. It is used for the treatment of generalized myasthenia gravis in antibody-positive patients. By lowering IgG levels, it helps improve muscle strength and reduce disease activity without broad immunosuppression. It is given as an intravenous infusion under medical supervision. Patients are monitored for infusion reactions and infection risks. Nipocalimab-aah is available in Infusion and strengths such as 300 mg/1.62 mL, 1200 mg/6.5 m. 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, Nipocalimab-aah 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) |
Nipocalimab-aah 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Nipocalimab-aahu is used for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients aged 12 years and older who are positive for anti-AChR or anti-MuSK antibodies.
It is made from a fully human IgG1λ monoclonal antibody designed to block the neonatal Fc receptor (FcRn), leading to a reduction in circulating IgG levels.
The trade name is Imaavy.
It is manufactured and marketed by Janssen Biotech, Inc., a part of Johnson & Johnson.
The generic name is nipocalimab-aahu.
The brand name is Imaavy.
The drug substance is manufactured by WuXi Biologics in China, and the final finished product is filled and packaged by Vetter Pharma in Germany.
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