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Description
PRODUCT DESCRIPTION:
Epirubicin is a potent anthracycline antineoplastic agent used in the treatment of various solid tumors.
It intercalates into DNA strands, inhibiting topoisomerase II and disrupting cell replication. Epirubicin is structurally similar to doxorubicin but demonstrates a more favorable cardiotoxicity profile, making it a preferred agent in certain protocols.
It is presented in both Pre-Filled Syringe for ready-to-administer convenience and Lyophilized powder for extended shelf-life and customized dosing.
Formulation & Presentation:
- Dosage Form: Sterile Injectable
- Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 10 MG/ 5 ML PFS
- 50 MG/25 ML PFS
- 100 MG/50 ML
- 10 MG (Lyophilized)
- 50 MG (Lyophilized)
- Route of Administration: Intravenous or as per clinical indication and severity. Reconstituted as per protocol Intravenous infusion. To be administered under supervision of a qualified oncologist. (As per physician’s discretion or decision)
Therapeutic Indications:
- Early and advanced breast cancer (including adjuvant use)
- Gastric cancer
- Ovarian carcinoma
- Lung cancer
- Soft tissue sarcomas
- In combination regimens for hematologic malignancies
Side Effects:
- COMMON:
- Nausea, vomiting
- Mucositis, stomatitis
- Reversible alopecia
- Injection site inflammation
- Myelosuppression (neutropenia, anemia)
- SERIOUS (RARE):
- Cardiotoxicity (dose-cumulative risk; ECG and LVEF monitoring advised)
- Secondary AML or MDS
- Hepatic dysfunction
- Severe myelosuppression with sepsis risk
- PRECAUTIONS:
- Avoid in patients with pre-existing heart failure or recent myocardial infarction
- Caution in hepatic impairment – dose adjustments required
- Must be administered under strict cytotoxic handling protocols
- Not recommended during pregnancy or breastfeeding
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TECHNICAL INFORMATION
Product Specifications
- HSN Code: To be assigned per international classification standards & import jurisdiction
- Weight: Approx. 40g per Carton (With Packaging)
- Dimensions: (15 x 1 x 8 CMS)
- Shelf Life: 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications
- Storage: Store below 2°C–8°C (Do not freeze). Requires cold-chain logistics. Protect from moisture and direct sunlight. Use strictly as per label guidelines.
Regulatory Status & Supply Information
- Regulatory Status: WHO-GMP Compliant Manufacturing. Further certifications available on request
- Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
- Stability: Compliant
- MOQ: Negotiable, based on market & registration status
- Export Options: Available for private label, institutional supply, or branded export
Who Should Source This Product?
- Oncology-focused hospitals and cancer treatment centers
- Government tender buyers for national cancer control programs
- NGOs and humanitarian aid groups operating in oncology care
- Institutional importers and ethical distributors in LATAM, Africa, South Asia
- Buyers seeking dossier-ready, GMP-compliant oncology injectables for long-term oncology supply chains
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation support for effective registration
- Trusted consortium network simplifying India’s pharma supply chain
- Multiple approved manufacturers for best fit in import country
- Network of audited, compliant manufacturers across India
- Customizable & flexible branding, packaging & formulation options
- End-to-end logistics support & flexibility
- Deep expertise in exporting specialty injectables & oncology products
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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