Description

Melphalan Film-Coated Tablets (2 mg)

Healthy Inc is a specialized global supplier and exporter of advanced high-containment oncology, hematology, and cold-chain therapeutics. We provide ultra-high-purity, kinetically stabilized Melphalan Film-Coated Tablets (2 mg), manufactured in WHO–GMP certified, strictly segregated OEB 5 cytotoxic oral solid dosage facilities. This “Bifunctional Alkylating Agent” is an ultra-high-value, highly restricted export to hematology-oncology centers, bone marrow transplant networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for the palliative and life-extending treatment of Multiple Myeloma and non-resectable Ovarian Carcinoma.

Product Overview

This highly advanced formulation utilizes a lethal, highly targeted nitrogen mustard derivative. It acts as a biochemical “handcuff” on the DNA of rapidly dividing cancer cells, physically preventing them from unzipping their genetic code and forcing the malignant plasma cells into immediate apoptosis (cellular suicide).

The “DNA-Crosslinking & Myeloma-Eradication” Specialist:

• Mechanism 1 (The Alkylating Blockade): Melphalan is a bifunctional alkylating agent. Once it enters the cancerous plasma cell in the bone marrow, it violently binds to the N7 position of guanine bases within the DNA. Because it is “bifunctional,” it binds to two separate strands of DNA at once, creating an unbreakable physical bridge (a cross-link). When the cancer cell attempts to divide, it cannot pull its DNA apart, resulting in catastrophic structural failure and immediate cell death.
• Mechanism 2 (The Multiple Myeloma Anchor): In Multiple Myeloma, malignant plasma cells crowd out healthy blood cells and literally bore holes into the patient’s bones. Melphalan has a highly specific affinity for these plasma cells. In elderly patients or those who cannot survive a brutal bone marrow transplant, oral Melphalan (often combined with Prednisone) is the globally mandated standard of care to aggressively crash the cancer burden and restore skeletal integrity.
• Mechanism 3 (The Phenylalanine Carrier): Unlike older, highly toxic nitrogen mustards, Melphalan is brilliantly engineered by attaching the active mustard gas group to the amino acid L-phenylalanine. This allows the drug to actively “hitch a ride” on the cell’s natural amino acid transport systems, dragging the lethal chemotherapy directly into the core of the cancer cell.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, handler-protective Amber Glass Bottles or specialized Alu-Alu cold-chain blisters to ensure the absolute chemical survival of the highly unstable alkylating agent.

*Pack Sizes: Amber Glass Bottles of 25/50 Tablets (Optimized specifically for strict, highly monitored hematology 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.

• High-Containment (OEB 5) & Cold-Chain Logistics (CRITICAL COMPLIANCE): Melphalan is a lethal, DNA-mutating antineoplastic. Our production occurs in entirely segregated, multi-million-dollar High-Containment Blocks utilizing closed-loop isolators and terminal HEPA filtration. Once manufactured, the tablets instantly enter our unbroken Cold-Chain Logistics network. From our factory refrigerators to specialized temperature-controlled air freight, we guarantee that the hospital receives 100% active, highly potent chemotherapy that has not suffered a single degree of thermal degradation.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of severe neoplastic diseases:

• Multiple Myeloma: Palliative and life-extending treatment of multiple myeloma, frequently utilized in continuous or “pulsed” regimens alongside Prednisone or newer biologics for patients ineligible for stem cell transplants.
• Ovarian Adenocarcinoma: Palliation of non-resectable ovarian carcinoma.
• AL Amyloidosis (Off-Label): Utilized to eradicate the plasma cells producing the toxic amyloid proteins that destroy organ function.

Dosage & Administration

Recommended Dosage (Strictly as per Hemato-Oncologist Guidelines):

• Pulsed Dosing Protocol (Myeloma): Typically calculated at 0.15 mg/kg/day for 7 days, followed by a rest period of 4 to 6 weeks to allow the bone marrow to recover before the next cycle.
• The “Intact Handling” Rule: Caregivers and patients MUST NOT break, crush, or chew the tablets. Handling broken tablets causes direct absorption of mutagenic chemotherapy through the skin. Pregnant nurses or caregivers must not handle this medication under any circumstances.
• Administration: Must be taken on an empty stomach to ensure maximum, rapid absorption, as food significantly drastically reduces its bioavailability.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Severe Bone Marrow Suppression): Melphalan causes profound, life-threatening leukopenia, thrombocytopenia, and anemia. It will completely obliterate the patient’s immune system. Weekly complete blood counts (CBC) are strictly mandatory. The drug must be halted if leukocyte or platelet counts crash dangerously low.
• BLACK BOX WARNING (Leukemogenic – Secondary Malignancies): Melphalan is a known human carcinogen. Surviving patients have a significantly increased risk of developing secondary acute nonlymphocytic leukemia (ANLL) or myeloproliferative syndromes years after treatment.
• BLACK BOX WARNING (Hypersensitivity): Severe, fatal anaphylactic reactions have occurred.
• Teratogenicity: Highly mutagenic. Can cause profound fetal death and chromosomal damage. Strict contraception is mandatory for both men and women during and long after therapy.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Hemato-Oncology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Alkylating Agents, Cytotoxics, and Cold-Chain Formulations. Whether you are looking for a reliable Government Tender Supplier for bone marrow cancer wards in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.