Mitomycin-C Inj 2 MG, 5 MG, 10 MG, 20 MG Pre-Filled Syringe
Mitomycin-C Inj 2 MG, 5 MG, 10 MG, 20 MG Pre-Filled Syringe - Image 2
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Mitomycin-C Inj 2 MG, 5 MG, 10 MG, 20 MG Pre-Filled Syringe - Image 4
Categories:, SKU: 00001-89
Mitomycin-C Inj 2 MG, 5 MG, 10 MG, 20 MG Pre-Filled Syringe

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Description

PRODUCT DESCRIPTION:

 

Mitomycin-C is a potent alkylating antineoplastic agent used in various solid tumors including gastrointestinal, pancreatic, bladder, and breast cancers.

It functions by inhibiting DNA synthesis and cross-linking DNA strands, making it especially effective against rapidly dividing tumor cells.

The pre-filled syringe format of Mitomycin-C enhances safety, accuracy, and efficiency in oncology practice minimizing exposure risks and preparation time, especially in high-pressure oncology units.

Formulation & Presentation:

  • Dosage Form: Sterile Injectable
  • Presentation: Both in Lyophilized & Pre-Filled Syringe (customizable as per market demand)
  • Available Strengths:
    • 2 MG
    • 5 MG
    • 10 MG
    • 20 MG
  • Route of Administration: Intra-Vesical (For superficial Bladder Cancer) as directed/ 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:

  • Gastric cancer
  • Pancreatic cancer
  • Breast cancer (advanced/metastatic)
  • Superficial bladder cancer (as intravesical therapy)
  • Palliative oncology regimens

Side Effects:

  • COMMON:
    • Nausea, vomiting
    • Myelosuppression (leukopenia, thrombocytopenia)
    • Fatigue, stomatitis
    • Temporary hair loss
  • SERIOUS (RARE):
    • Pulmonary fibrosis
    • Hemolytic-uremic syndrome
    • Severe bone marrow suppression
    • Renal impairment
  • PRECAUTIONS:
    • Strict hematological monitoring during therapy
    • Use cautiously in patients with renal or hepatic dysfunction
    • Avoid cumulative dosing beyond prescribed limits
    • Requires use in specialized oncology setup
    • Not for use in pregnancy/lactation unless life-saving

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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: Store below 2°C–8°C for pre-filled syringes (Do not freeze). Requires cold-chain logistics. Protect from moisture and direct sunlight. Use strictly as per label instructions.

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 programs
  • Procurement teams in LATAM, Africa & South Asia targeting bladder, gastric, or pancreatic cancers
  • Distributors handling oncology injectables requiring strict documentation and safety compliance

Why Source from PHARMET?

  • Single-window sourcing for a wide range of pharma needs
  • Export-ready regulatory documentation & technical dossiers
  • Adaptable registration support based on target country
  • Consortium-backed network simplifying India’s pharma supply chain
  • Multiple WHO-approved manufacturers for country-fit solutions
  • Audited manufacturing partners across India
  • Customizable branding, packaging & formulation options
  • Complete logistics support, including cold-chain assurance
  • Proven expertise in high-compliance specialty injectables

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