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Description
PRODUCT DESCRIPTION:
5-Fluorouracil (5-FU) is a widely used antimetabolite chemotherapy agent belonging to the pyrimidine analog family.
It disrupts DNA synthesis by inhibiting thymidylate synthase, leading to cell death in rapidly dividing cancer cells.
The pre-filled syringe format ensures ready-to-use, sterile administration with enhanced safety and reduced preparation time in clinical environments.
Formulation & Presentation:
- Dosage Form: Sterile Injectable
- Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 250 MG/ 5 ML
- 500 MG/ 10 ML
- 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) Administered as a bolus or continuous infusion, typically as part of combination chemotherapy regimens
Therapeutic Indications:
- B-cell Chronic Lymphocytic Leukemia (CLL)
- Low-grade Non-Hodgkin’s Lymphomas
- Acute Leukemias (off-label)
- Bone Marrow Conditioning Regimens (as per protocol)
Side Effects:
- COMMON:
- Nausea, vomiting, diarrhea
- Stomatitis and mucositis
- Myelosuppression (anemia, leukopenia, thrombocytopenia)
- Hand-foot syndrome
- Fatigue
- SERIOUS (RARE):
- Cardiotoxicity (angina, arrhythmias)
- Severe neutropenia and sepsis
- Neurotoxicity
- Gastrointestinal bleeding
- PRECAUTIONS:
- Monitor complete blood counts during treatment
- Use cautiously in patients with pre-existing cardiac conditions
- Requires antiemetic premedication in high-dose regimens
- Dose adjustment may be required in patients with hepatic or renal dysfunction
- Handle with PPE under cytotoxic handling protocols
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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. COA, MSDS, Stability Data, Manufacturing Batch Record, and Dossier Support (on request). Further certifications available.
- 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 hospitals and cancer care centers treating GI and breast cancers
- Government and private healthcare tenders sourcing chemotherapy agents
- Importers requiring pre-filled syringe (PFS) formats for clinical efficiency
- NGOs and humanitarian aid groups supplying oncology programs in LATAM, Africa, and South Asia
- Distributors and wholesalers expanding oncology-focused generic portfolios
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation for effective product registration in target markets
- Trusted consortium network simplifying India’s complex pharma supply chain
- Multiple approved manufacturers matched to import country requirements
- Audited and compliant manufacturing partners across India
- Flexible branding, packaging & formulation options
- End-to-end logistics coordination & support
- Deep expertise in exporting specialty injectables & complex products
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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