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.
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.
Darleukin Injection — third party manufacturing & bulk supply
Darleukin Injection is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
Manufacturers of Darleukin Injection listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Darleukin Injection →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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