Filgrastim Injection 300 MCG/1 ML
Categories:, , SKU: 00001-62
Filgrastim Injection 300 MCG/1 ML

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Description

PRODUCT DESCRIPTION:

 

Filgrastim is a recombinant human granulocyte colony-stimulating factor (rHuG-CSF) that stimulates the bone marrow to produce neutrophils, a type of white blood cell vital in fighting infection.

The Filgrastim Injection 300 MCG/1 ML pre-filled syringe is designed for convenient subcutaneous or intravenous administration.

Used as a supportive therapy in patients undergoing chemotherapy, bone marrow transplantation, or suffering from neutropenia, Filgrastim plays a critical role in reducing infection-related complications and hospitalization rates.

This high-quality formulation is biosimilar-compliant and suitable for markets with stringent regulatory requirements.

Formulation & Presentation:

  • Dosage Form: Injectable Pre Filled Syringe
  • Presentation: 300 MCG/1 ML Pre-Filled Syringe (customizable as per market demand)
  • Available Strengths: 300 MCG Filgrastim in 1 ML solution for injection
  • Route of Administration: Sub Cutaneous or IV Injection (SC/IV), or as per clinical indication and severity (As per physician’s discretion or decision)

Therapeutic Indications:

  • Chemotherapy-induced neutropenia
  • Bone marrow transplantation support
  • Severe chronic neutropenia (SCN)
  • Neutropenia due to HIV/AIDS or other immunosuppressive conditions
  • Peripheral blood progenitor cell (PBPC) mobilization

Side Effects:

  • COMMON:
    • Bone pain
    • Headache
    • Injection site redness or swelling
    • Mild fever or fatigue
  • SERIOUS (RARE):
    • Splenic rupture
    • Acute respiratory distress syndrome (ARDS)
    • Allergic reactions (rash, swelling, anaphylaxis)
    • Sickle cell crisis in susceptible individuals
  • PRECAUTIONS:
    • Use under supervision of a qualified oncologist or hematologist
    • Regular monitoring of white blood cell counts recommended
    • Not to be administered simultaneously with chemotherapy
    • Caution in patients with pre-existing spleen or pulmonary conditions
    • Ensure product is stored and transported under cold chain (2–8°C) conditions

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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. Cold chain mandatory.
  • Storage: 2–8°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. Further certifications available on request
  • 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?

  • Hospitals & Oncology Centers involved in cancer treatment and bone marrow transplant programs
  • Government & Humanitarian Agencies addressing chemotherapy access in underserved regions
  • NGOs & Relief Missions in need of biologic essentials for immunocompromised patients
  • Distributors & Importers catering to high-value, cold-chain injectable portfolios
  • Institutional Buyers in LATAM, Africa, Middle East & Asia looking for dossier-ready biosimilars

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 & flexibility
  • Deep expertise in exporting specialty injectables & biosimilars

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