Crizanlizumab Infusion Suppliers & Bulk Manufacturers
Available Forms: Infusion Solution
Available Strengths: 10 mg/mL
Reference Brands: Adakveo(US)
Category:
Blood Disorder
Crizanlizumab is a monoclonal antibody that binds to P-selectin, blocking cell adhesion and reducing blood vessel blockages. It decreases the frequency of vaso-occlusive crises in sickle cell disease, offering benefits like improved quality of life, fewer pain episodes, and reduced hospitalizations through targeted, biological therapy.
Crizanlizumab infusion is available in Infusion Solution
and strengths such as 10 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, Crizanlizumab infusion 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) |
Crizanlizumab infusion 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:
Crizanlizumab, marketed as Adakveo, is approved in both the US by the FDA and in the EU via EMA for reducing vaso-occlusive crises in sickle cell disease. Regulatory approval requires a comprehensive dossier with clinical trial data, safety, efficacy, manufacturing details, and pharmacovigilance plans. In the US, the FDA review involves detailed submission of clinical results, while the EU approval adheres to rigorous regional standards. For expert guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance with regional regulations is essential for successful approval, safe use, and commercialization of crizanlizumab infusion solutions worldwide.
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