Darleukin Injection Suppliers & Bulk Manufacturers
Available Forms: Intralesional injection
Available Strengths: A standardized dose of 120 million adipose-derived stem cells per injection
Reference Brands: Alofisel(US & EU)
Category:
Cell & Gene Therapies
Darleukin (alofisel) is a stem cell therapy that promotes healing of Crohn's disease-related anal fistulas by reducing inflammation and supporting tissue regeneration. It benefits patients with refractory fistulas, leading to improved healing rates, decreased symptoms, and enhanced quality of life when administered in specialized centers under medical supervision.
Darleukin Injection is available in Intralesional injection
and strengths such as A standardized dose of 120 million adipose-derived stem cells per injection.
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, Darleukin 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) |
Darleukin 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.
Product Description:
Darleukin (alozifil) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involved extensive clinical trial data and safety assessments. In the EU, CE marking certifies conformity with MDR standards for treatment of Crohn’s disease-related perianal fistulas. These gene therapies undergo validation, stability testing, and thorough audits, with comprehensive documentation including safety profiles, clinical trial results, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to advanced biologic therapies supporting complex Crohn’s disease management globally.
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