Dalbavancin Hydrochloride API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Dalvance, Xydalba

Category: Active Pharmaceutical Ingredient

Dalbavancin hydrochloride is a semi-synthetic lipoglycopeptide antibiotic used in long-acting injectables. It is sourced by sterile antibiotic manufacturers, CDMOs and R&D teams.

Product Description:

Dalbavancin is a semi-synthetic lipoglycopeptide antibiotic, made from a fermentation-derived glycopeptide, that binds to the cell-wall building blocks of Gram-positive bacteria and anchors in their membrane, which also gives it a very long half-life. It is approved for acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria, including MRSA, in adults and paediatric patients (reference brand: Dalvance, Xydalba).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 4 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 (Nov 2025). European Union: No confirmed date.

Handling and quality points

Because dalbavancin is a defined mixture of homologues rather than a single molecule, the specification has to control the ratio of the B0 and minor components as well as related substances, and the profile should match the reference product. Its fermentation origin brings the usual points to check: residual media components, bioburden and endotoxin, all critical for a sterile lyophilised injectable. Store it dry and protected from heat, and confirm the hydrochloride stoichiometry and water content on each batch.

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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.