Cladribine API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Mavenclad

Category: Active Pharmaceutical Ingredient

Cladribine is a chlorinated purine nucleoside analogue used in tablets for relapsing multiple sclerosis and in injections for hairy cell leukaemia. It is sourced by formulators and CDMOs.

Product Description:

Cladribine is a synthetic analogue of deoxyadenosine with a chlorine atom on the purine ring, which makes it resistant to breakdown by adenosine deaminase; it builds up in lymphocytes and causes them to die, giving a lasting reduction in B and T cells. As tablets it is approved for relapsing forms of multiple sclerosis in adults (reference brand: Mavenclad), and as an injection it is used for hairy cell leukaemia.

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 10 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: Generics/biosimilars on the market (Dec 2025). European Union: No confirmed date.

Handling and quality points

Cladribine is a cytotoxic drug and is handled under high-potency containment with validated cleaning. It is stable at neutral and slightly basic pH but hydrolyses under acidic conditions, with 2-chloroadenine as the main degradant, so pH during processing and storage matters. The reference tablet contains hydroxypropyl betadex, and injectable-grade material needs endotoxin and microbial limits suited to parenteral use, so tell the supplier which product the API is for.

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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.