Pemetrexed Pre-Filled Syringe, 100 MG & 500 MG
Pemetrexed Pre-Filled Syringe, 100 MG & 500 MG - Image 2
Categories:, SKU: 00001-93
Pemetrexed Pre-Filled Syringe, 100 MG & 500 MG

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Description

PRODUCT DESCRIPTION:

 

Pemetrexed is a multi-targeted antifolate chemotherapeutic agent used primarily in the treatment of non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma.

It inhibits several key folate-dependent enzymes involved in DNA and RNA synthesis, leading to apoptosis in rapidly dividing cancer cells.

The ready-to-administer pre-filled syringe format offers enhanced safety, dosing accuracy, and convenience for oncology healthcare providers in high-demand infusion centers.

Formulation & Presentation:

  • Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
  • Presentation: Pre-Filled Syringe (customizable as per market demand)
  • Available Strengths:
    • 100 MG (Pre-Filled Syringe)
    • 500 MG (Pre-Filled Syringe)
  • Route of Administration: Intravenous (IV) Slow Injection over 10 Minutes/ 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:
    • Fatigue
    • Nausea, vomiting
    • Loss of appetite
    • Anemia, neutropenia
    • Mucositis, rash
  • SERIOUS (RARE):
    • Myelosuppression leading to severe infections
    • Interstitial pneumonitis
    • Kidney function impairment
    • Hepatic enzyme elevation
    • Stevens-Johnson syndrome (very rare)
  • PRECAUTIONS:
    • Folic acid and Vitamin B12 supplementation are mandatory to reduce hematologic and GI toxicity
    • Administer corticosteroids (e.g., dexamethasone) to minimize skin reactions
    • Monitor renal and hepatic function before each cycle
    • Contraindicated in patients with creatinine clearance < 45 mL/min
    • Use only under supervision of an experienced oncology healthcare professional

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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 storage conditions from date of manufacture (subject to country-specific guidelines)
  • Storage:
    • Store below 15°C–25°C for pre-filled syringes (Do not freeze)
    • Lyophilized vials to be stored at room temperature below 25°C
    • No cold-chain logistics required
    • Protect from moisture and direct sunlight
    • Use strictly as per label guidelines

Regulatory Status & Supply Information

  • Manufacturing Compliance: WHO-GMP certified
  • Available Documentation: COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request)
  • Export Dossiers: COA, COPP, CTD/eCTD format dossiers available
  • 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?

  • Oncology distributors catering to cancer hospitals, daycare units & infusion centers
  • Pharma procurement teams sourcing formulations for NSCLC and mesothelioma
  • Government & institutional tender buyers requiring lyophilized injectables
  • Global importers seeking quality-assured, documentation-ready oncology products
  • Healthcare providers shifting from vial to pre-filled syringe formats

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation for smooth registration in target markets
  • Trusted consortium simplifying India’s pharma supply chain
  • Multiple approved manufacturers for best market fit
  • Network of audited & compliant Indian manufacturers
  • Flexible branding, packaging & formulation options
  • End-to-end logistics support for domestic & international routes
  • Proven expertise in specialty injectable exports

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