Normal Human Albumin 100 ML
Categories:, , SKU: 00015-147
Normal Human Albumin 100 ML

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Description

PRODUCT DESCRIPTION:

 

Normal Human Albumin 100 ML is a plasma-derived sterile solution containing purified albumin protein from pooled human plasma.

It serves as a volume expander and colloidal osmotic agent, crucial in restoring and maintaining blood volume in critically ill patients.

Manufactured under stringent GMP and viral inactivation processes, this product ensures high safety, purity, and efficacy.

Widely used in hypovolemia, hypoalbuminemia, burns, shock, trauma, and surgeries, it supports oncotic pressure and improves microcirculation and oxygen delivery. This formulation is heat-treated and triple-checked to reduce the risk of pathogen transmission.

Other Product Highlights: Derived from certified human plasma with viral inactivation/ Complies with USP/BP standards/ Sterile, pyrogen-free solution/ Validated for osmolarity, pH, and purity/ Safe for use in sensitive critical care settings

Formulation & Presentation:

  • Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
  • Presentation: Pre-Filled Syringe (customizable as per market demand)
  • Available Strengths:
    • 100 ML Vial
  • Route of Administration: Intravenous for select indications. To be used only in advanced clinical settings, as per clinical indication and severity. To be administered under supervision of a qualified specialist only. (As per physician’s discretion or decision)

Therapeutic Indications:

  • Mild fever or flushing
  • Nausea
  • Chills or headache
  • Temporary increase in blood pressure

Side Effects:

  • COMMON:
    • Mild fever or flushing
    • Nausea
    • Chills or headache
    • Temporary increase in blood pressure
  • SERIOUS (RARE):
    • Anaphylaxis or hypersensitivity
    • Pulmonary edema due to volume overload
    • Hypotension
    • Coagulopathy (in very high doses)
  • PRECAUTIONS:
    • Monitor for fluid overload, especially in patients with cardiac or renal insufficiency
    • Use caution in patients with known allergies to plasma proteins
    • Ensure proper blood volume parameters and electrolyte balance before administration
    • Not for use in dehydration without hypoproteinemia
    • Use only in a hospital setting under expert supervision

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TECHNICAL INFORMATION

Product Specifications:

  • HSN Code: To be assigned per international classification standards & import jurisdiction
  • Weight: Approx. 40 GM per Carton (With Packaging)
  • Dimensions: (15x1x8 CMS)
  • Shelf Life (Subject To Country Specific Guidelines): 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications
  • Storage: Store between 2°C to 25°C for Vials (Do not freeze). Does not require cold-chain logistics. Protect from moisture and direct sunlight. Use as per label guidelines

Regulatory Status & Supply Information:

  • Regulatory Status: WHO-GMP Complaint Manufacturing. COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request). Further certifications available on request
  • Exports Ready Dossiers: COA, COPP, Dossier Available (CTD/eCTD formats). Complies with USP/EP/BP Standards
  • 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?

  • Tertiary hospitals & emergency departments handling trauma, shock, and burn care
  • ICUs and critical care units managing fluid resuscitation in sepsis and ARDS
  • Oncology and transplant centers needing albumin replenishment
  • NGOs and humanitarian agencies operating in high-risk or disaster-affected zones
  • Importers and government health missions across LATAM, Africa, South Asia, and conflict-prone regions needing safe and dependable human albumin therapy

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation support for effective registration in global markets
  • Trusted consortium network simplifying India’s complex pharma supply chain
  • Multiple approved manufacturers suited for diverse import country requirements
  • Network of audited, compliant manufacturers across India
  • Customizable & flexible branding, packaging & formulation options
  • End-to-end logistics flexibility & support
  • Deep expertise in exporting specialty injectables & therapeutic products

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