Abatacept Intravenous (Iv) Powder Suppliers & Bulk Manufacturers
Available Forms: Intravenous (IV) Powder
Available Strengths: 250 mg/vial
Reference Brands: Orencia(US & EU)
Category: Arthritis
Abatacept inhibits T-cell activation by blocking CD80/CD86 co-stimulatory signals, reducing inflammation in autoimmune diseases. Benefits include rapid symptom relief, slowed disease progression, improved joint function, and convenient IV administration. It offers effective disease control with a good safety profile when monitored properly. Abatacept Intravenous (IV) Powder is available in Intravenous (IV) Powder and strengths such as 250 mg/vial. 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, Abatacept Intravenous (IV) Powder 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) |
Abatacept Intravenous (IV) Powder 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.
Product Description:
Abatacept IV powder is approved in both the EU and US for rheumatoid arthritis and other autoimmune diseases. In the EU, brands like Orencia are regulated by EMA, with dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval relies on comprehensive clinical data, biosimilarity assessments, and ongoing pharmacovigilance. Both regions require detailed dossiers for approval and continuous safety monitoring. For expert support with regulatory dossiers, registration, and compliance, visit PharmaTradz. We streamline market access for abatacept IV products, ensuring adherence to European and US standards for safe, effective biologic therapies, helping you navigate complex regulatory landscapes efficiently.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Abatacept is used to treat autoimmune conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis. It reduces inflammation and helps prevent joint damage by inhibiting T-cell activation.
Abatacept is a recombinant fusion protein composed of the extracellular domain of human CTLA-4 linked to a modified Fc portion of human IgG1. This engineered protein blocks costimulatory signals required for full T-cell activation.
The primary trade name for abatacept is Orencia.
Orencia (abatacept) is marketed by Bristol Myers Squibb.
The generic name is abatacept.
The brand name is Orencia.
Orencia is manufactured in approved Bristol Myers Squibb facilities, primarily in the United States and at additional licensed manufacturing sites in Europe for global supply.
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