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Description
PRODUCT DESCRIPTION:
Fludarabine is a purine analog antimetabolite used primarily in the treatment of hematological malignancies. It interferes with DNA synthesis, leading to apoptosis in rapidly dividing malignant cells.
The pre-filled syringe presentation ensures precise dosage, minimized contamination risk, and reduced preparation time in clinical use, particularly for immunocompromised cancer patients.
Formulation & Presentation:
- Dosage Form: Sterile Injectable
- Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 150 MG/2 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)
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:
- Myelosuppression (anemia, neutropenia, thrombocytopenia)
- Nausea, vomiting
- Fatigue
- Fever
- Infections due to immunosuppression
- SERIOUS (RARE):
- Neurotoxicity (especially at high doses)
- Pulmonary toxicity
- Autoimmune hemolytic anemia
- Opportunistic infections (e.g., PCP, CMV)
- PRECAUTIONS:
- Must be administered under strict hematology/oncology supervision
- Monitor complete blood counts and immune function during therapy
- Caution in patients with renal impairment
- Avoid live vaccines during and after treatment
- Use appropriate PPE while handling cytotoxic agents
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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?
- Ministries of Health procuring for national cancer treatment programs
- Government-funded hospitals and oncology centers
- Non-profit cancer foundations in LATAM, Africa, South & Southeast Asia
- Humanitarian organizations and global health programs
- Pharmaceutical importers seeking PFS format injectables with full documentation
- Distributors building oncology portfolios with ready-to-administer formulations
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 with flexibility
- Deep expertise in exporting specialty injectables & all pharma products
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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