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Remibrutinib bulk supplier for pharma manufacturers

Remibrutinib Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 25 mg

Reference Brands: Generic formulations marketed under different names

Category: Immune Disorder

Remibrutinib is available in Tablets and strengths such as 25 mg. 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, Remibrutinib 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)

Remibrutinib 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.

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📘 Sourcing Guide

Product Description:

Remibrutinib is an oral, highly selective Bruton’s tyrosine kinase (BTK) inhibitor developed for the treatment of immune-mediated and inflammatory disorders. It is designed to target BTK, a key signaling enzyme involved in B-cell activation, antibody production, and downstream inflammatory pathways that contribute to autoimmune and allergic diseases.

By covalently and selectively inhibiting BTK, remibrutinib helps suppress abnormal immune responses while minimizing off-target effects commonly associated with earlier BTK inhibitors. This targeted mechanism supports effective control of inflammation and immune dysregulation without broad immunosuppression. Remibrutinib has shown promising clinical efficacy in reducing disease activity and symptom severity across multiple immune-driven conditions.

The drug is being developed by Novartis and has been evaluated extensively in clinical trials, particularly for chronic spontaneous urticaria and other inflammatory disorders where current treatment options may be limited or insufficient. Its oral administration offers added convenience for long-term disease management.

Through its precision-based approach and favorable safety profile observed in clinical studies, remibrutinib represents an important advancement in the next generation of targeted therapies for immune and inflammatory diseases, addressing unmet medical needs and improving patient quality of life.

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Frequently Asked Questions

Remibrutinib is an investigational drug being studied for the treatment of immune-mediated and inflammatory disorders, including chronic spontaneous urticaria.

Remibrutinib is a small-molecule, synthetic Bruton’s tyrosine kinase inhibitor.

Remibrutinib does not yet have an approved trade name.

Remibrutinib is developed by Novartis.

The generic name of Remibrutinib is remibrutinib.

There is currently no approved brand name for remibrutinib.

Remibrutinib is manufactured for clinical and development use by Novartis through regulated pharmaceutical manufacturing facilities.

Yes, Remibrutinib is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Remibrutinib is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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