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Calicheamicin API (ADC Payload) Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Mylotarg, Besponsa

Category: Active Pharmaceutical Ingredient

Calicheamicin is an enediyne antitumour antibiotic used as the cytotoxic payload in antibody-drug conjugates. It is sourced by ADC developers and conjugation CDMOs.

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Product Description:

Calicheamicins are enediyne antibiotics produced by the bacterium Micromonospora echinospora; they cut double-stranded DNA and are far too toxic to be given on their own. A derivative, N-acetyl gamma calicheamicin dimethylhydrazide, is the payload in approved antibody-drug conjugates for CD33-positive acute myeloid leukaemia (reference brand: Mylotarg) and relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (reference brand: Besponsa).

Specification at a glance

Traded formValues are for calicheamicin gamma1I, the fermentation product. ADCs use the N-acetyl dimethylhydrazide derivative, often supplied as a linker-payload; confirm the exact structure and CAS with the supplier.
CAS number108212-75-5
Molecular formulaC55H74IN3O21S4
Molecular weight1368.34 g/mol
PharmacopoeiaNo pharmacopoeia monograph found; 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

Calicheamicin is among the most potent cytotoxic agents used in medicine and needs isolator-level containment, specially trained staff and verified decontamination. Enediynes are chemically reactive, so agree storage temperature, light protection and shipping conditions with the supplier and ask for stability data on the exact derivative or linker-payload you will conjugate. Plan transport as a highly toxic substance under dangerous goods rules.

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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.

Calicheamicin API (ADC Payload) — third party manufacturing & bulk supply

Calicheamicin API (ADC Payload) 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

Calicheamicin API (ADC Payload) 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 Calicheamicin API (ADC Payload) listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Typically a GMP certificate covering the fermentation and chemical steps, a CoA and full specification for the payload or linker-payload, and an impurity profile with structural data. For a filing you will also want a DMF letter of access or equivalent, stability data, and containment and cleaning information.

Most ADC programmes buy a derivatised form ready for conjugation, such as the N-acetyl dimethylhydrazide joined to an acid-labile hydrazone linker, rather than the natural gamma1I product. Confirm the exact structure and linker chemistry, and how the supplier controls related calicheamicin species.

Yes. PharmaTradz connects licensed manufacturers, ADC developers, CDMOs and R&D teams with GMP-compliant producers of calicheamicin payloads, and we check documents before any introduction. Your details stay private until both parties agree.

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