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Categories:Antimetabolite Cytotoxic Agent, Oncology
SKU:
00001-82
Gemcitabine 200 MG, 1 GM, 1.4 GM Pre-Filled Syringe / Lyophilized
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PRODUCT DESCRIPTION:
Gemcitabine is a nucleoside analog used as a chemotherapeutic agent. It interferes with DNA synthesis, selectively targeting proliferating cancer cells.
It is widely utilized across multiple solid tumors and is known for its high tolerability in outpatient settings.
Available in Pre-Filled Syringe and Lyophilized powder formats, this product offers versatility for a range of oncology protocols.
Formulation & Presentation:
- Dosage Form: Sterile Injectable
- Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 200 MG
- 1000 MG (1 GM)
- 4 GM
- 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:
- Non-small cell lung cancer (NSCLC)
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Biliary tract cancers
Side Effects:
- COMMON:
- Nausea and vomiting
- Myelosuppression (neutropenia, anemia, thrombocytopenia)
- Flu-like symptoms (fever, fatigue)
- Elevation in liver enzymes
- Rash or injection site reactions
- SERIOUS (RARE):
- Hemolytic uremic syndrome (HUS)
- Pulmonary toxicity (pneumonitis)
- Hepatic dysfunction
- Capillary leak syndrome
- Anaphylactic reactions (rare)
- PRECAUTIONS:
- Close monitoring of hematologic parameters required
- Dose adjustment in hepatic/renal impairment
- Use under supervision of oncology-trained professionals
- Cytotoxic precautions during handling, administration, and disposal
- Avoid live vaccinations during therapy
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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:
- For Pre-Filled Syringes (PFS): Store between 2°C – 8°C (Do not freeze)
- For Lyophilized Injection: Store below 25°C (Do not freeze)
Regulatory Status & Supply Information
- Regulatory Status: WHO-GMP Compliant Manufacturing. COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support available on request
- Exports Ready Dossiers: Available in 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?
- National oncology programs requiring affordable high-efficacy generics
- Government and tender agencies in LATAM, Africa, and South Asia
- NGOs and humanitarian agencies serving oncology patients in underserved regions
- Hospitals and infusion centers prioritizing pre-filled formats for ease and safety
- Pharma distributors and importers expanding cytotoxic oncology portfolios
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation for effective registration across markets
- Trusted consortium network simplifying India’s pharma supply chain
- Multiple approved manufacturers for import country-specific compliance
- Network of audited, GMP-compliant manufacturers across India
- Flexible branding, packaging & formulation options
- End-to-end logistics support with flexibility
- Deep expertise in exporting specialty injectables and oncology products
Contact Details
- Email: hello@pharmet.io
- Phone/WhatsApp: +91 9999091881
- Website: www.pharmet.io
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