Cyclophosphamide Injection

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Cyclophosphamide injection (brand name Cytoxan) is a potent cytotoxic chemotherapy agent and immunosuppressant. It is typically supplied as a sterile, white cake or powder in a vial for reconstitution.

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Description

Cyclophosphamide Injection

Healthy Inc is a specialized global supplier and exporter of high-stability alkylating agents. We provide high-purity Cyclophosphamide Injection (200 mg / 500 mg / 1 g), sourced from WHO–GMP certified sterile cytotoxic facilities. This “Oncology & Rheumatology Powerhouse” is a top export to cancer centers, rheumatology clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a versatile cornerstone therapy for both malignant cancers and severe autoimmune diseases like Lupus Nephritis.


Product Overview

This formulation contains Cyclophosphamide Monohydrate, a nitrogen mustard alkylating agent that requires metabolic activation in the liver.

The “Prodrug” Specialist:

  • Mechanism (Hepatic Activation): Cyclophosphamide is inactive until it is metabolized by liver enzymes (CYP450) into 4-hydroxycyclophosphamide. This breaks down into the active killer, Phosphoramide Mustard (which cross-links DNA to stop cell division), and a toxic byproduct, Acrolein.
  • Dual-Action Utility:
    • Oncology: It is a key component of the famous CHOP regimen (Lymphoma) and AC regimen (Breast Cancer).
    • Autoimmune: It is a potent immunosuppressant used to “reset” the immune system in life-threatening Lupus Nephritis and Vasculitis (Wegener’s).
  • Stem Cell Mobilization: High doses are used to mobilize stem cells from the bone marrow into the blood prior to harvesting for transplants.

Product Composition & Strength

We supply this product as a Sterile Lyophilized Powder for Injection in glass vials.

Active Ingredient Strength Primary Use
Cyclophosphamide USP/BP 200 mg Vial Low Dose / Autoimmune
Cyclophosphamide USP/BP 500 mg Vial Standard Chemotherapy
Cyclophosphamide USP/BP 1000 mg (1 g) Vial High Dose / Hematology
Excipients Mannitol / Sodium Chloride Bulking Agent (For Cake Structure)

*Pack Sizes: Tray of 1 Vial, 10 Vials, or Box of 1/10 Vials.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

HS Code 3004.90.99 (Antineoplastic medicaments)
Dosage Form Lyophilized Powder for Injection
Packaging Type I Glass Vial (Sterile) with Flip-off Seal
Storage Strictly Store below 25°C. (Ideal 2°C-8°C). Above 30°C, the powder melts into a glass-like damp mass and degrades.
Certificates WHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

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

  • Thermal Stability Control: Cyclophosphamide has a low melting point. If the cold chain breaks during transport, the powder “sinters” (shrinks) or melts. We use advanced lyophilization cycles that create a robust cake structure resistant to minor temperature excursions, ensuring the product arrives intact even in hot climates.
  • Solubility Assurance: Our micro-crystalline formulation ensures that upon adding saline, the powder dissolves vigorously (often with shaking) without leaving residue.

Therapeutic Indications (Human Use)

Indicated for the treatment of:

  • Malignant Lymphomas: Hodgkin’s and Non-Hodgkin’s (Part of CHOP/CVP).
  • Breast Cancer: Adjuvant therapy (Part of AC/CAF).
  • Leukemia: CLL, ALL, and AML.
  • Lupus Nephritis: Severe organ-threatening autoimmune disease.
  • Multiple Myeloma: In combination with Prednisone.
  • Ovarian Cancer: Advanced stages.

Dosage & Administration

Recommended Dosage (Strictly as per Oncologist):

  • Route: Intravenous (IV) Infusion. (Can be given Oral if tablets available).
  • Standard Adult Dose: 500 mg to 1000 mg/m² IV every 3-4 weeks.
  • Lupus Nephritis: 500 mg to 1000 mg/m² monthly pulses for 6 months (“NIH Protocol”).
  • Reconstitution: Dissolve in 0.9% Sodium Chloride. Shake vigorously.
  • Hydration Protocol: Patients must be hyper-hydrated (2-3 Liters of fluid) before and after infusion to flush out Acrolein.

Safety Warnings (CRITICAL):

  • Hemorrhagic Cystitis (Bladder Bleeding): The metabolite Acrolein accumulates in the bladder, causing severe chemical burns and bleeding.
    • Prevention: MESNA (Uromitexan) injection is mandatory for high doses to neutralize Acrolein.
    • Hydration: Frequent voiding of urine is essential.
  • Bone Marrow Suppression: Leukopenia peaks at 7-14 days. Susceptibility to infection is high.
  • Infertility: Causes premature ovarian failure and azoospermia (often permanent).
  • Alopecia: Severe hair loss occurs in most patients.

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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