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Description
PRODUCT DESCRIPTION:
Voriconazole is a broad-spectrum triazole antifungal agent indicated for the treatment of serious, invasive fungal infections caused by Aspergillus, Candida, and other emerging fungal pathogens.
Its superior tissue penetration and effectiveness in immunocompromised patients make it a gold-standard therapy in advanced infectious disease care, particularly in oncology and transplant settings.
Formulation & Presentation:
- Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 200 MG (Pre-Filled Syringe/ Lyophilized Inj)
- Route of Administration: Slow Intravenous (IV) over 1 to 2 Hours, 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:
- Invasive Aspergillosis
- Candidemia in non-neutropenic patients
- Serious infections caused by Scedosporium and Fusarium species
- Treatment of fungal infections in febrile neutropenic patients unresponsive to other therapies
Side Effects:
- COMMON:
- Visual disturbances
- Rash
- Fever
- Nausea
- Headache
- Elevated liver enzymes
- SERIOUS (RARE):
- Hepatotoxicity,
- QT prolongation
- Hallucinations
- Severe dermatologic reactions
- PRECAUTIONS:
- Requires dose adjustment in patients with hepatic dysfunction
- Monitor liver function, renal function, and serum electrolytes during therapy
- Use with caution in patients with known cardiac arrhythmias
- Avoid co-administration with certain CYP3A4 substrates (e.g., sirolimus, rifampin)
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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 / Lyophilized Form (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?
- Critical care and infectious disease hospitals
- Oncology and transplant centers requiring high-grade antifungal prophylaxis
- National health procurement agencies and public health programs
- NGOs and humanitarian groups supporting immunocompromised patient care
- Pharmaceutical importers seeking WHO-GMP compliant antifungal injectables
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation for smooth global registration
- Trusted consortium simplifying India’s pharma supply chain
- Multiple approved manufacturers tailored to import country requirements
- Network of audited, GMP-compliant Indian manufacturers
- Customizable branding, packaging & formulation flexibility
- Comprehensive end-to-end logistics and cold-chain support
- Proven track record in exporting specialty injectables globally
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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