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Description
PRODUCT DESCRIPTION:
Vincristine is a cytotoxic chemotherapy agent belonging to the vinca alkaloid class, derived from the periwinkle plant (Catharanthus roseus).
It works by binding to tubulin and inhibiting microtubule formation, thus preventing cancer cell mitosis. It is a critical component of several combination chemotherapy regimens used in both pediatric and adult cancers.
The pre-filled syringe format ensures superior sterility, safety, and reduced risk of dosage errors—particularly important for high-alert medications like vincristine.
Formulation & Presentation:
- Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 11 MG/ ML (Pre-Filled Syringe)
- 20 MG/ 2ML (Pre-Filled Syringe)
- 50 MG/ 5 ML (Pre-Filled Syringe)
- Route of Administration: Intravenous (IV), 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:
- Acute Lymphoblastic Leukemia (ALL)
- Hodgkin’s and Non-Hodgkin’s Lymphoma
- Wilms’ Tumor
- Neuroblastoma
- Rhabdomyosarcoma
- Ewing’s Sarcoma
- Multiple Myeloma (in combination regimens)
- Small Cell Lung Cancer (SCLC)
Side Effects:
- COMMON:
- Peripheral neuropathy (dose-limiting)
- Constipation
- Alopecia
- Jaw pain
- Mild leukopenia
- Local injection site irritation
- SERIOUS (RARE):
- Severe neurotoxicity (motor weakness, cranial nerve involvement)
- SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion)
- Paralytic ileus
- Severe myelosuppression (though less common with vincristine)
- Accidental intrathecal administration is uniformly fatal
- PRECAUTIONS:
- Absolutely contraindicated for intrathecal use – special labeling and handling required
- Use with caution in patients with pre-existing neuropathies or hepatic impairment
- Monitor for signs of neurotoxicity, including jaw pain, paresthesia, and difficulty walking
- Adjust dosage based on clinical response and toxicity
- Pregnant and breastfeeding women should avoid exposure
- Administer only under direct supervision of an oncology specialist
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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
- Documents: COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request), further certifications available
- 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-focused importers and distributors supplying tertiary care hospitals
- Government and institutional tenders sourcing essential oncology injectables
- Cancer treatment centers requiring sterile, safe-to-use cytotoxic pre-filled syringes
- International buyers targeting regulated and semi-regulated markets with dossier-backed products
- Pharmaceutical wholesalers needing vincristine in customizable volumes for pediatric and adult protocols
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation for efficient market registration
- Trusted consortium simplifying India's complex pharma supply chain
- Multiple approved manufacturers suited for various import jurisdictions
- Audited & compliant manufacturing network across India
- Flexible branding, packaging, and formulation customization
- End-to-end logistics support including cold-chain
- Deep expertise in exporting specialty injectables & cytotoxic products
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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