Oncology & Anticancer

EpirubicinThird Party Manufacturing in India

Looking to get Epirubicin 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
56390-09-1
Drug Class
Anthracycline antineoplastic antibiotic
Molecular Formula
C₂₇H₂₉NO₁₁·HCl
Molecular Weight
579.98 g/mol
Grade Standards
IP, BP, USP, EP
Therapeutic Category
Oncology & Anticancer
MOQ
Contact us for MOQ — oncology products have specific batch sizes
Dosage Forms
Injection

Mechanism of Action

Epirubicin works by directly entering cancer cells and disrupting their ability to copy and repair their DNA, thereby stopping tumor growth.

As an anthracycline antineoplastic agent, Epirubicin exerts its effects through multiple cellular pathways. It intercalates between adjacent base pairs of the DNA double helix, which physically blocks the replication and transcription enzymes. It binds to and inhibits topoisomerase II, an enzyme crucial for maintaining DNA structure during cell division. By stabilizing the DNA-enzyme cleavage complex, Epirubicin prevents DNA strands from resealing, causing double-stranded DNA breaks. Additionally, it undergoes cellular reduction to generate reactive oxygen species that damage lipid membranes and cellular proteins.

Unlike traditional alkylating agents, Epirubicin acts during multiple phases of the cell cycle, offering broad efficacy against rapidly dividing tumor cells. It is widely utilized in oncology regimens because of its slightly better safety profile and lower cardiotoxicity compared to its parent compound, doxorubicin.

Therapeutic Uses & Indications

Epirubicin (CAS 56390-09-1) is a critical anthracycline chemotherapy agent widely utilized in oncology care. Celesta provides high-quality solutions for Epirubicin third party manufacturing in India, supplying global markets with sterile injectable formulations.

Therapeutic Uses

Epirubicin is prescribed for the treatment of:

  • Breast Cancer: Used as an adjuvant treatment in patients with node-positive breast cancer following surgical resection of the primary tumor.
  • Gastric Cancer: Employed in combination chemotherapy regimens for advanced or metastatic stomach cancers.
  • Ovarian and Uterine Cancers: Utilized in treatment protocols for advanced gynecological malignancies.
  • Small Cell Lung Cancer: Used as part of multi-agent chemotherapy regimens for systemic management.
  • Lymphomas: Included in combination therapies for Hodgkin's and non-Hodgkin's lymphomas.

Choosing an Epirubicin Manufacturer in India

Epirubicin is a key chemotherapy drug listed on the World Health Organization (WHO) Model List of Essential Medicines. It remains a standard of care globally for breast cancer treatments, ensuring steady demand from institutional oncology departments, government tenders, and export markets. For pharmaceutical distributors, partnering with a reliable Epirubicin manufacturer is key to entering the specialized oncology tender market. Because it is a cytotoxic drug, formulation requires dedicated high-containment suites in WHO-GMP certified facilities to ensure absolute operator safety and zero cross-contamination. Sourcing Epirubicin injection from a WHO-GMP certified partner in India guarantees sterile, pyrogen-free vials that comply with international pharmacopoeias.

To place an order or discuss customization, please contact our team. You can view all our oncology injectables on our manufacturing listing page or learn about our service offerings on our contract manufacturing page.

This makes Epirubicin one of the most sought-after oncology molecules for third party manufacturing in India, with consistent demand from specialized oncology clinics and export-oriented distributors.

Dosage Forms We Manufacture

Injection
10mg · 50mg · 100mg

Frequently Asked Questions

What is the minimum order quantity for Epirubicin?
Minimum order quantity for Epirubicin is Contact us for MOQ — oncology products have specific batch sizes. Please contact us for bulk pricing and custom quantities.
What dosage forms of Epirubicin can you manufacture?
We manufacture Epirubicin as: Injection (10mg, 50mg, 100mg).
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 Epirubicin for export?
Yes. We provide export-ready Epirubicin 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 Epirubicin?
We manufacture Epirubicin to IP, BP, USP, EP pharmacopoeial standards.
Third Party Manufacturing

Get Epirubicin made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
Get a Manufacturing QuoteWhatsApp Us Now

+91 9689237122 · replies within hours

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

Sterile glass vial in protective mono carton. Light-resistant primary packaging for stability.

Start Manufacturing Epirubicin Today

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

Need something? Chat with us!