Darleukin Injection bulk supplier for pharma manufacturers

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)

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.

Get Enquiry / Request Bulk Quote

Quick Response Guaranteed | Verified Suppliers

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:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Darleukin Injection is supplied as Intralesional injection — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and 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.

Request a quote for Darleukin Injection →

Back to Listing

Frequently Asked Questions

Darleukin Injection is listed as Intralesional injection in A standardized dose of 120 million adipose-derived stem cells per injection. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Darleukin Injection is referenced against Alofisel(US & EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.