Description

Cyclophosphamide Sugar-Coated / Film-Coated Tablets (50 mg)

Healthy Inc is a specialized global supplier and exporter of advanced oncology, rheumatology, and targeted high-containment cytotoxic therapeutics. We provide ultra-high-purity, kinetically stabilized Cyclophosphamide Tablets (50 mg), manufactured in WHO–GMP certified, strictly segregated maximum-containment (OEB 5) oncology oral solid dosage facilities. This “Hepatically-Activated Alkylating Agent” is a massive-volume, highly strategic export to oncology networks, specialized rheumatology centers, mega-NGOs, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for malignant lymphomas, leukemias, and severe, refractory autoimmune diseases.

Product Overview

This highly advanced formulation operates as a profound, DNA-shattering saboteur. It is an inactive prodrug that travels safely through the stomach until it reaches the liver, where it is converted into a highly toxic “nitrogen mustard” that violently halts the replication of rapidly dividing cancer cells and hyperactive immune cells.

The “Alkylating Prodrug & Genomic Saboteur” Specialist:

• Mechanism 1 (The Hepatic Activation): Cyclophosphamide is clinically inert until it is metabolized by Cytochrome P450 (CYP450) enzymes in the liver. It is cleaved into two primary active metabolites: Phosphoramide mustard (the ultimate anti-tumor agent) and Acrolein (a toxic byproduct). This prodrug mechanism allows the drug to be absorbed orally before unleashing its cytotoxic payload systemically.
• Mechanism 2 (DNA Cross-Linking): Once inside the rapidly dividing cancer or immune cell, phosphoramide mustard violently alkylates the DNA. It physically binds to the guanine bases, creating unbreakable cross-links between the DNA strands. When the cell attempts to replicate its DNA to divide, the cross-links cause the DNA to physically snap, instantly triggering apoptosis (programmed cell death).
• Mechanism 3 (The Immunosuppressive Sweep): In lower, daily oral doses, Cyclophosphamide acts as a profound immunosuppressant. It aggressively crushes the proliferation of both B-lymphocytes and T-lymphocytes, making it the ultimate “salvage” therapy for stopping organ-destroying autoimmune attacks, particularly in Lupus Nephritis and severe Rheumatoid Arthritis.

Product Composition & Strength

We supply this product as a Precision-Blended, Cytotoxic Prodrug Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips or heavy-gauge HDPE bottles to ensure the absolute chemical stability of the sensitive nitrogen mustard derivative and to physically protect caregivers from API exposure.

*Pack Sizes: Bottles of 50/100 or 10×10 Alu-Alu Blisters (Optimized specifically for strict chronic oncology and rheumatology dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Oncology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

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

• OEB 5 Cytotoxic Containment & Zero Cross-Contamination (CRITICAL COMPLIANCE): Cyclophosphamide is a highly potent, mutagenic, and carcinogenic chemical. Manufacturing this drug in a standard facility would catastrophically contaminate other medicines. Our oncology suites operate under the absolute highest global safety standards—Occupational Exposure Band 5 (OEB 5). We utilize fully enclosed isolators, negative-pressure cascading, and terminal HEPA exhaust filtration to guarantee 100% worker safety and zero cross-contamination, providing global buyers with a flawless, liability-free cytotoxic product.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of life-threatening malignancies and autoimmune attacks:

• Malignant Diseases: Malignant lymphomas (Stages III and IV), Hodgkin’s disease, lymphocytic lymphoma, multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, and carcinoma of the breast.
• Non-Malignant Diseases: Biopsy-proven “minimal change” nephrotic syndrome in children who fail to adequately respond to corticosteroids. Off-label for severe, refractory Systemic Lupus Erythematosus (SLE) and Lupus Nephritis.

Dosage & Administration

Recommended Dosage (Strictly as per Oncologist/Rheumatologist Guidelines):

• Standard Oral Dosing: Usually 1 to 5 mg/kg/day for both initial and maintenance dosing, depending highly on the specific protocol and the patient’s blood counts.
• The “Do Not Crush” Cytotoxic Mandate (CRITICAL): Tablets MUST be swallowed completely whole. Chewing, crushing, or breaking the tablet exposes the patient and caregivers to highly toxic API dust, which can be absorbed through the skin or lungs. Caregivers should wear gloves when handling the tablets.
• The Hydration Protocol: Patients MUST drink massive amounts of water and empty their bladder frequently (especially before bedtime) to flush the toxic metabolite (acrolein) out of the bladder.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX EQUIVALENT (Myelosuppression): Causes severe, potentially fatal suppression of the bone marrow. Leukopenia, thrombocytopenia, and anemia are expected. Complete Blood Counts (CBC) must be monitored continuously. The drug must be halted if a severe infection develops.
• Hemorrhagic Cystitis (FATAL WARNING): The hepatic byproduct Acrolein is violently toxic to the bladder lining. It can cause severe, sometimes fatal bleeding from the bladder (hemorrhagic cystitis). Aggressive hydration and the use of the uroprotective drug Mesna may be required.
• Secondary Malignancies: Because it damages DNA, patients treated with Cyclophosphamide have a significantly higher risk of developing secondary cancers (especially urinary bladder cancer and myeloproliferative malignancies) years after treatment.
• Teratogenicity & Sterility: Highly teratogenic (causes severe birth defects or fetal death). It frequently causes permanent sterility (amenorrhea in women, azoospermia in men).

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Oncology/Rheumatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antineoplastics, Cytotoxic Alkylating Agents, and OEB 5 High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for national cancer institutes in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.