Erythropoietin Prefilled Syringe Injection

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An Erythropoietin (EPO) pre-filled syringe contains a sterile solution of recombinant human erythropoiesis-stimulating agents (ESAs) used to treat anaemia. The formulation consists of the active hormone, stabilizers, and buffers designed for subcutaneous or intravenous administration.

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Description

Erythropoietin (EPO) Injection (Prefilled Syringe)

Healthy Inc is a specialized global supplier and exporter of high-value recombinant biologics. We provide high-purity Recombinant Human Erythropoietin (rHuEPO) Injection (2000 IU / 4000 IU / 10000 IU) in convenient Prefilled Syringes (PFS), sourced from WHO–GMP certified biological facilities. This “Blood Builder” is a top export to dialysis centers, oncology clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the standard of care for anemia associated with Chronic Kidney Disease (CKD) and Chemotherapy.


Product Overview

This formulation contains Epoetin Alfa/Beta, a glycoprotein hormone produced by recombinant DNA technology (rDNA) that mimics natural erythropoietin.

The “Anemia” Specialist:

  • Mechanism (Erythropoiesis): The kidneys normally produce EPO to signal the bone marrow to make red blood cells. In Chronic Kidney Disease (CKD), this production fails, leading to severe anemia. Injectable EPO binds to progenitor cells in the bone marrow, stimulating them to mature into red blood cells, thereby correcting hemoglobin levels without the need for blood transfusions.
  • Chemotherapy Support: Cancer chemotherapy often destroys red blood cells. EPO helps maintain hemoglobin levels, reducing fatigue and the need for transfusions in cancer patients.
  • PFS Convenience: The Prefilled Syringe (PFS) format ensures exact dosing, sterility, and ease of use for self-administration by dialysis patients or rapid use by nurses.

Product Composition & Strength

We supply this product as a Sterile Liquid in a Prefilled Syringe (PFS) with a fine needle.

Active Ingredient Strength (IU) Patient Profile
Recombinant Human Erythropoietin 2000 IU / 0.5 ml Maintenance / Low Weight
Recombinant Human Erythropoietin 4000 IU / 0.4 ml Standard Dialysis Dose
Recombinant Human Erythropoietin 10000 IU / 1.0 ml Chemotherapy / High Dose
Stabilizer Human Albumin / Polysorbate Prevents Protein Aggregation

*Pack Sizes: Blister Pack of 1 PFS or Box of 6 PFS.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code 3002.10.19 (Immunological products/hormones)
Dosage Form Liquid Injection (PFS)
Packaging Glass Prefilled Syringe with Needle Guard in Blister
Storage (CRITICAL) Store at 2°C to 8°C (Refrigerate). DO NOT FREEZE. Do not shake. Cold Chain Mandatory.
Certificates WHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Cold Chain Integrity: Erythropoietin is a protein that denatures if frozen or overheated. We utilize validated cold-chain packaging (insulated shippers with data loggers) to ensure the temperature remains between 2°C and 8°C from our warehouse to your airport.
  • Shear Stress Protection: Proteins are sensitive to shaking (“shear stress”). Our formulation includes stabilizers like Polysorbate or Amino Acids to prevent the protein from unfolding during transport, ensuring full biological potency.

Therapeutic Indications (Human Use)

Indicated for the treatment of anemia due to:

  • Chronic Kidney Disease (CKD): Patients on dialysis (Hemodialysis/PD) and pre-dialysis patients.
  • Chemotherapy: Non-myeloid malignancies where anemia is caused by the drug effect.
  • HIV Therapy: Anemia caused by Zidovudine treatment.
  • Surgery: To reduce the need for allogenic blood transfusions in elective surgery.

Dosage & Administration

Recommended Dosage (Strictly as per Nephrologist/Oncologist):

  • Route: Subcutaneous (SC) or Intravenous (IV). (SC is preferred for pre-dialysis as it sustains levels longer).
  • CKD Anemia: 50 to 100 IU/kg body weight, 3 times a week. Titrate to maintain Hemoglobin between 10-11.5 g/dL.
  • Chemotherapy Anemia: 150 IU/kg, 3 times a week OR 40,000 IU once weekly.
  • Handling: Do not shake the syringe. Shaking destroys the protein.

Safety Warnings (CRITICAL):

  • Hypertension: EPO raises blood pressure by increasing blood viscosity. Monitor BP regularly. Uncontrolled hypertension is a contraindication.
  • Thrombosis (Blood Clots): Raising Hemoglobin > 12 g/dL increases the risk of stroke, myocardial infarction, and vascular access thrombosis (fistula clotting). Target Hb should not exceed 11.5 g/dL.
  • Pure Red Cell Aplasia (PRCA): Rare autoimmune reaction where the body attacks the EPO. If efficacy suddenly drops, test for antibodies.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.

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