Anidulafungin API Suppliers & Bulk Manufacturers
Available Forms: API (drug substance)
Available Strengths: USP grade or in-house specification
Reference Brands: Eraxis, Ecalta
Category: Active Pharmaceutical Ingredient
Anidulafungin is a semi-synthetic echinocandin antifungal used in sterile injectables. It is sourced by antifungal manufacturers, CDMOs and R&D teams.
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Product Description:
Anidulafungin is a semi-synthetic echinocandin antifungal, made from a fermentation product of Aspergillus nidulans, that blocks 1,3-beta-D-glucan synthase and so weakens the fungal cell wall. In the US it is approved for candidaemia and other Candida infections (intra-abdominal abscess and peritonitis) in adults and children from 1 month of age, and for oesophageal candidiasis in adults; in the EU it is approved for invasive candidiasis (reference brand: Eraxis, Ecalta).
Specification at a glance
| Traded form | Cyclic lipopeptide; fermentation-derived echinocandin B nucleus acylated with an alkoxy-terphenyl side chain |
|---|---|
| CAS number | 166663-25-8 |
| Molecular formula | C58H73N7O17 |
| Molecular weight | 1140.2 g/mol |
| Pharmacopoeia | No official pharmacopoeia monograph found. Anidulafungin was on the USP priority list for new monographs in 2024; supplied to an in-house specification. |
Regulatory files and timing
The FDA list of Drug Master Files (third quarter 2026) shows 2 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: No confirmed date. European Union: No confirmed date.
Handling and quality points
Anidulafungin degrades slowly by opening of its cyclic peptide ring, so the ring-opened product and related degradants should be specified and tracked on stability, with cold storage usual. Its fermentation origin means residual media components, bioburden and endotoxin need control for a sterile lyophilised injectable. It is poorly soluble in water, so confirm the material's physical properties suit your reconstitution process.
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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.
Anidulafungin API — third party manufacturing & bulk supply
Anidulafungin API 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:
Indicative minimum order quantity
Anidulafungin API is supplied as API (drug substance) — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. 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 Anidulafungin API listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.
Request a quote for Anidulafungin API →Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.
Frequently Asked Questions
Buyers generally ask for the GMP certificate, a US DMF letter of access or EU ASMF, a CoA covering related substances, endotoxin and microbial limits, and stability data. A summary of the fermentation and semi-synthesis steps, a TSE/BSE statement and a nitrosamine risk assessment are also routine. Ask for the impurity profile compared with the reference product.
The main one is the ring-opened peptide formed by hydrolysis of the cyclic hexapeptide, which increases with temperature and time. Suppliers should report it and other related substances on release and stability, with data under the proposed storage conditions. Ask whether the related-substance method separates all known echinocandin impurities.
Yes. PharmaTradz connects licensed manufacturers, CDMOs and R&D teams with GMP-compliant anidulafungin makers once we have checked their documents. Your company stays anonymous until both parties are happy to proceed.
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