Antibiotic & Anti-infective

IdarubicinThird Party Manufacturing in India

Looking to get Idarubicin manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
58957-92-9
Drug Class
Anthracycline Antineoplastic Agent
Molecular Formula
C₂₆H₂₇NO₉
Molecular Weight
497.50 g/mol
Grade Standards
IP, USP, BP, EP
Therapeutic Category
Antibiotic & Anti-infective
MOQ
Contact us for MOQ — varies by strength and batch size
Dosage Forms
Lyophilized Injection

Mechanism of Action

Idarubicin is an anthracycline chemotherapy drug, a class of medications originally derived from certain soil bacteria. It works through multiple mechanisms that collectively damage cancer cell DNA and trigger cell death. The primary action of idarubicin is to insert itself between the base pairs of the DNA double helix, a process called intercalation. This intercalation distorts the shape of the DNA molecule and interferes with its normal functions, including transcription and replication. Additionally, idarubicin targets an enzyme called topoisomerase II, which cells need to untangle and manage DNA during replication. By inhibiting this enzyme, idarubicin prevents the DNA strands from being properly separated and copied, leading to breaks in the DNA chain that the cell cannot repair. The drug also generates harmful free radicals that cause oxidative damage to DNA and other cellular structures. What makes idarubicin particularly effective compared to other anthracyclines is its high lipophilicity, meaning it is more fat-soluble. This property allows it to enter cells much more rapidly and achieve higher intracellular concentrations. Once inside the cell, it is also metabolized into an active form called idarubicinol, which has a long half-life and continues to exert anticancer effects for an extended period. The combination of DNA intercalation, topoisomerase II inhibition, and free radical generation creates overwhelming genomic damage that rapidly dividing leukemia cells cannot repair, ultimately leading to programmed cell death.

Therapeutic Uses & Indications

Therapeutic Uses

Idarubicin is prescribed for the treatment of:

  • Acute Myeloid Leukemia (AML): Indicated for the treatment of adults with acute myeloid leukemia, including French-American-British classifications M1 through M7. It is used as a component of combination chemotherapy regimens, typically alongside cytarabine.
  • Induction Therapy: Used for remission induction in adult patients with previously untreated AML. The standard regimen consists of idarubicin 12 mg/m² daily for 3 days in combination with cytarabine.
  • Recurrent or Refractory AML: Used in combination with cytarabine for the treatment of acute myeloid leukemia that has relapsed or is resistant to initial therapy.

Why Manufacturers Choose Idarubicin

Idarubicin is a high-potency anthracycline that plays a critical role in the treatment of acute myeloid leukemia, one of the most common forms of leukemia in adults. Its position as a key component of standard AML induction regimens ensures consistent demand from oncology centers and hospitals worldwide. As a semi-synthetic anthracycline, it requires specialized manufacturing expertise, making it a differentiated product for Indian manufacturers with advanced injectable production facilities. The growing incidence of leukemia globally and the expansion of cancer care infrastructure in emerging markets continue to drive demand for this essential medicine. This makes Idarubicin one of the most sought-after molecules for third party manufacturing in India, with consistent demand from PCD franchise operators and export-oriented companies.

Dosage Forms We Manufacture

Lyophilized Injection
5mg/vial · 10mg/vial

Frequently Asked Questions

What is the minimum order quantity for Idarubicin?
Minimum order quantity for Idarubicin is Contact us for MOQ — varies by strength and batch size. Please contact us for bulk pricing and custom quantities.
What dosage forms of Idarubicin can you manufacture?
We manufacture Idarubicin as: Lyophilized Injection (5mg/vial, 10mg/vial).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Idarubicin for export?
Yes. We provide export-ready Idarubicin formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Idarubicin?
We manufacture Idarubicin to IP, USP, BP, EP pharmacopoeial standards.
Third Party Manufacturing

Get Idarubicin made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
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Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Single-dose amber glass vial, carton pack with package insert. Packaging customized to client brand guidelines with cytotoxic warning labels.

Start Manufacturing Idarubicin Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Idarubicin across all dosage forms. PCD franchise and export orders welcome.

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