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Nipocalimab-aah bulk supplier for pharma manufacturers

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.

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Nipocalimab-Aah — third party manufacturing & bulk supply

Nipocalimab-Aah 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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Nipocalimab-Aah is supplied as Infusion — 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 Nipocalimab-Aah listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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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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