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 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.

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.