Defibrotide Sodium API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Defitelio

Category: Active Pharmaceutical Ingredient

Defibrotide sodium is a mixture of oligonucleotides derived from porcine intestinal DNA, used in an injection for hepatic veno-occlusive disease. Specialist injectable makers and R&D teams source it.

Product Description:

Defibrotide is a mixture of mostly single-stranded oligodeoxyribonucleotides with profibrinolytic properties, helping to restore the balance between clot formation and breakdown in the small blood vessels of the liver. It is approved for adults and children with hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome, after haematopoietic stem-cell transplantation; the US label covers cases with renal or pulmonary dysfunction and the EU label covers severe disease (reference brand: Defitelio).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 0 active Type II API DMFs for this molecule. Few filings usually means few qualified sources, so early contact with suppliers pays off. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (to 2032 (non-compound patents)). European Union: No confirmed date.

Handling and quality points

As an animal-derived substance, defibrotide needs full traceability of the porcine source, viral safety and TSE documentation, and a clear description of the extraction and depolymerisation process. Quality rests on more than chemical purity: molecular weight distribution, chain composition and biological potency all need to match the reference product, so ask how each is measured. It goes into an injectable, so bioburden, endotoxin and the supplier's controls on microbial quality matter.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.