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Eculizumab 300 mg Injection bulk supplier for pharma manufacturers

Eculizumab 300 Mg Injection Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 300mg/30ml

Reference Brands: Bkemv (USA), Soliris (EU/LATAM)

Category: Orphan Drugs

Eculizumab injection is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). This medicine helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH. Eculizumab 300 mg Injection is available in Injection and strengths such as 300mg/30ml. 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, Eculizumab 300 mg Injection 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)

Eculizumab 300 mg Injection 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:

Eculizumab-aeeb is a highly targeted biologic medicine used in the treatment of rare complement-mediated disorders, particularly paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare genetic condition characterized by intermittent destruction of red blood cells due to uncontrolled activation of the complement system. The underlying cause of PNH is a deficiency of CD59, a natural complement inhibitor that normally protects red blood cells from the membrane attack complex (MAC). Without this protective mechanism, red blood cells are vulnerable to complement-mediated lysis, leading to anemia, fatigue, and other complications.

Eculizumab-aeeb works by specifically inhibiting complement protein C5, effectively preventing the formation of the MAC and reducing the destruction of red blood cells. This targeted mechanism helps control hemolysis, improves patient quality of life, and reduces the risk of complications associated with PNH. As a recombinant monoclonal antibody, Eculizumab-aeeb is produced using advanced biotechnology and is available in regulated markets across the United States, Europe, and other international regions. Its clinical effectiveness has made it a cornerstone therapy for patients living with this rare and life-impacting condition.

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Frequently Asked Questions

Eculizumab-aeeb is used for the treatment of rare and serious complement-mediated disorders. It is indicated for conditions such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It works by inhibiting the complement protein C5, which helps prevent the destruction of red blood cells and reduces damage caused by uncontrolled complement system activation.

Eculizumab-aeeb is a recombinant monoclonal antibody produced using advanced biotechnology in genetically engineered cell lines. It is designed to specifically target and block complement component C5.

A commonly known trade name associated with this biosimilar is Bkemv.

Eculizumab-aeeb is manufactured by Amgen and distributed in regulated markets where biosimilar approvals are granted.

The generic name is Eculizumab-aeeb.

One of the well-known brand names is Bkemv. The reference product in this category is Soliris.

Eculizumab-aeeb is manufactured in regulated biopharmaceutical production facilities in countries such as the United States and other regions that follow strict biologics manufacturing and quality standards.

Yes, Eculizumab 300 mg Injection 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, Eculizumab 300 mg Injection 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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