Oxaliplatin Inj – Liquid 50 MG/25 ML, 100 MG/50 ML Pre-Filled Syringe; Lyophilized 50 MG, 100 MG
Oxaliplatin Inj – Liquid 50 MG/25 ML, 100 MG/50 ML Pre-Filled Syringe; Lyophilized 50 MG, 100 MG - Image 2
Oxaliplatin Inj – Liquid 50 MG/25 ML, 100 MG/50 ML Pre-Filled Syringe; Lyophilized 50 MG, 100 MG - Image 3
Oxaliplatin Inj – Liquid 50 MG/25 ML, 100 MG/50 ML Pre-Filled Syringe; Lyophilized 50 MG, 100 MG - Image 4
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Oxaliplatin Inj – Liquid 50 MG/25 ML, 100 MG/50 ML Pre-Filled Syringe; Lyophilized 50 MG, 100 MG

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Description

PRODUCT DESCRIPTION:

 

Oxaliplatin is a third-generation platinum compound used extensively in the management of colorectal cancer. It works by forming platinum-DNA adducts, thereby inhibiting DNA replication and transcription.

It is a cornerstone drug in FOLFOX and other combination chemotherapy regimens.

This product is available in both liquid (ready-to-use) and lyophilized (powder-for-reconstitution) formats, ensuring flexibility in hospital and outpatient chemotherapy settings.

The pre-filled syringe presentation offers increased safety, precision dosing, and reduced handling errors, making it a preferred choice for busy oncology clinics and infusion centers.

Formulation & Presentation:

  • Dosage Form: Sterile Injectable
  • Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
  • Available Strengths:
    • 50 MG/ 25 ML (Pre-Filled Syringe)
    • 100 MG/ 50 ML (Pre-Filled Syringe)
    • 50 MG (Lyophilized Vial)
    • 100 MG (Lyophilized Vial)
  • Route of Administration: Intravenous (IV) Slow Injection/ Infusion after appropriate reconstitution or as per clinical indication and severity. Reconstituted as per protocol Intravenous infusion. To be administered under supervision of a qualified oncologist or day-care oncology units. (As per physician’s discretion or decision) Administered as continuous infusion, typically as part of combination chemotherapy regimens

Therapeutic Indications:

  • Advanced colorectal cancer
  • Stage III colon cancer (adjuvant setting post-surgery)
  • Off-label uses in gastric and pancreatic cancers under protocol guidance

Side Effects:

  • COMMON:
    • Nausea and vomiting
    • Peripheral neuropathy (cold-induced)
    • Diarrhea
    • Fatigue
    • Myelosuppression
  • SERIOUS (RARE):
    • Anaphylactic reactions
    • Pulmonary toxicity
    • Hepatotoxicity (including sinusoidal obstruction syndrome)
    • Nephrotoxicity
  • PRECAUTIONS:
    • Monitor for neuropathy and adjust dose accordingly
    • Ensure adequate hydration pre- and post-infusion
    • Use in combination chemotherapy only under oncologist supervision
    • Avoid cold beverages and exposure post-infusion due to cold sensitivity

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TECHNICAL INFORMATION

Product Specifications

  • HSN Code: To be assigned per international classification & import jurisdiction
  • Weight: Approx. 40g per carton (with packaging)
  • Dimensions: 15 x 1 x 8 CMS
  • Shelf Life: 24–36 months under recommended conditions from date of manufacture (as per country-specific guidelines)
  • Storage:
    • Pre-Filled Syringes: Store below 2°C–8°C (Do not freeze). Requires cold-chain logistics.
    • Lyophilized Vials: Store at room temperature below 25°C.
    • Protect from moisture and direct sunlight. Use strictly as per label guidelines.

Regulatory Status & Supply Information

  • Manufacturing Compliance: WHO-GMP Certified
  • Documentation: COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request)
  • Export Dossiers: Available in CTD/eCTD formats (COA, COPP included)
  • Stability: Compliant
  • MOQ: Negotiable (based on market & registration status)
  • Export Options: Private label, institutional supply, or branded export

Who Should Source This Product?

  • Cancer hospitals and oncology centers requiring ready-to-administer cytotoxic injectables
  • Importers seeking dossier-ready, pre-filled oncology products
  • Government agencies and NGOs in anti-cancer therapy access programs
  • Hospitals and procurement agents in LATAM, Africa & South Asia focused on bladder, gastric, or pancreatic cancers
  • Distributors handling oncology drugs requiring high documentation & safety standards

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable registration support tailored to each country
  • Trusted consortium simplifying India’s pharma supply chain
  • Access to multiple WHO-approved manufacturers
  • Audited, compliant manufacturer network across India
  • Customizable branding, formulation & packaging flexibility
  • End-to-end logistics with cold-chain support
  • Strong track record in exporting specialty injectables

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