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Description
PRODUCT DESCRIPTION:
Vinorelbine is a semi-synthetic vinca alkaloid with a targeted mechanism of action that inhibits microtubule assembly, disrupting mitosis and inhibiting cancer cell proliferation.
It is widely used in the treatment of non-small cell lung cancer (NSCLC) and advanced breast cancer, offering significant clinical benefit with manageable toxicity when appropriately dosed.
Formulation & Presentation:
- Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 10 MG/ ML (Pre-Filled Syringe)
- 20 MG/ 2ML (Pre-Filled Syringe)
- 50 MG/ 5 ML (Pre-Filled Syringe)
- Route of Administration: Slow Intravenous (IV) over 6 to 10 Minutes, as per clinical indication and severity. Reconstituted as per protocol Intravenous Injection. To be administered under supervision of a qualified oncologist or day-care oncology units. (As per physician’s discretion or decision) Administered as part of chemotherapy regimens.
Therapeutic Indications:
- Non-small cell lung cancer (NSCLC) – both first-line and palliative
- Advanced or metastatic breast cancer (second-line treatment)
- Other investigational and off-label indications in solid tumors
Side Effects:
- COMMON:
- Neutropenia
- Nausea
- Vomiting
- Injection site reactions
- Constipation
- Fatigue
- SERIOUS (RARE):
- Neurotoxicity,
- Severe myelosuppression,
- Hepatotoxicity,
- Phlebitis
- PRECAUTIONS:
- Avoid intrathecal administration (fatal if administered this way)
- Use with caution in patients with hepatic dysfunction
- Monitor complete blood counts before each dose
- Ensure drug is administered only by trained oncology professionals
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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: 24–36 months under recommended storage from date of manufacture (subject to country-specific guidelines)
- Storage:
- Store between 2°C–8°C for Pre-Filled Syringes (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
- Documentation: COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request)
- Export Dossiers: COA, COPP, CTD/eCTD Formats
- Standards: Complies with USP/EP/BP
- 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 hospitals and infusion centers
- Government-run cancer therapy programs
- Pharmaceutical procurement agencies in Africa, LATAM, CIS, and Asia
- Humanitarian health missions and non-profit cancer treatment foundations
- Institutional buyers seeking quality-assured PFS oncology injectables
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation for effective registration in target markets
- Trusted consortium simplifying India's complex pharma supply chain
- Multiple approved manufacturers for best fit per import country requirements
- Network of audited, GMP-compliant manufacturers across India
- Customizable branding, packaging, and formulation options
- Flexible, end-to-end logistics support including cold-chain handling
- Proven expertise in specialty injectable exports
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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