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Pegcetacoplan bulk supplier for pharma manufacturers

Pegcetacoplan Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 54 mg/mL, 15 mg/mL

Reference Brands: Empaveli (USA/EU), Syfovre(USA/EU)

Category: Opthalmology

Pegcetacoplan is a targeted complement inhibitor that binds to complement protein C3, preventing its cleavage and downstream inflammatory effects. It is used in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and geographic atrophy secondary to age-related macular degeneration (AMD). It helps reduce red blood cell destruction and slow retinal damage progression. Pegcetacoplan is available in Injection and strengths such as 54 mg/mL, 15 mg/mL. 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, Pegcetacoplan 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)

Pegcetacoplan 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:

Pegcetacoplan is a pegylated peptide inhibitor that targets human complement components C3 and C3b, playing an important role in the treatment of diseases driven by excessive complement activation. By selectively binding to C3 and C3b, pegcetacoplan blocks the activation of the complement pathway, helping to reduce complement-mediated inflammation and cell destruction. This mechanism is particularly important in conditions where the immune system damages healthy cells and tissues.

Pegcetacoplan is primarily used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder characterized by the destruction of red blood cells. It is also approved in certain regions for the treatment of geographic atrophy associated with age-related macular degeneration. In addition, pegcetacoplan is being studied or used in conditions such as cold agglutinin disease and C3 glomerulopathy, where complement system dysregulation contributes to disease progression.

By targeting C3, a central component of the complement system and an essential part of the innate immune response, pegcetacoplan helps control abnormal immune activity and prevent tissue damage. This targeted approach provides a valuable therapeutic option for patients with complement-mediated disorders and related inflammatory diseases.

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Frequently Asked Questions

Pegcetacoplan is used for the treatment of certain complement-mediated disorders. It is primarily indicated for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood condition where red blood cells are destroyed prematurely by the immune system. It is also approved in some regions for the treatment of geographic atrophy associated with age-related macular degeneration. Pegcetacoplan works by inhibiting the complement component C3, which helps reduce red blood cell destruction and disease progression.

Pegcetacoplan is a targeted complement inhibitor composed of a synthetic cyclic peptide conjugated to polyethylene glycol (PEG). This structure allows the drug to bind specifically to complement protein C3 and C3b, helping block activation of the complement cascade that contributes to inflammation and cell damage.

Pegcetacoplan is marketed under the trade names Empaveli for the treatment of paroxysmal nocturnal hemoglobinuria and Syfovre for the treatment of geographic atrophy in ophthalmology.

Pegcetacoplan was developed and is marketed by Apellis Pharmaceuticals, a biotechnology company focused on complement inhibition therapies.

The generic name of the medicine is pegcetacoplan.

The main brand names are Empaveli and Syfovre.

Pegcetacoplan is manufactured through global biologics manufacturing facilities that supply approved markets such as the United States, Europe, and other regulated regions, following international pharmaceutical quality and regulatory standards.

Yes, Pegcetacoplan 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, Pegcetacoplan 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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