Description

Temozolomide Capsules

Healthy Inc is a specialized global supplier and exporter of advanced neuro-oncology and antineoplastic therapeutics. We provide ultra-high-purity, structurally validated Temozolomide Capsules (20 mg / 100 mg / 140 mg / 250 mg), manufactured in WHO–GMP certified, strictly dedicated negative-pressure hazardous oncology facilities. This “Blood-Brain Barrier Penetrating Alkylating Agent” is a high-value, critical-care export to comprehensive cancer centers, neurosurgery wards, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, life-prolonging intervention for Glioblastoma Multiforme (GBM) and refractory Anaplastic Astrocytoma.

Product Overview

This formulation contains Temozolomide, a highly advanced imidazotetrazine derivative. Unlike most chemotherapy drugs that are blocked by the brain’s natural defenses, Temozolomide is specifically engineered to treat aggressive central nervous system tumors.

The “Neuro-Oncology & DNA Alkylating” Specialist:

• Mechanism (The Spontaneous MTIC Conversion): Temozolomide is a prodrug, but uniquely, it doesn’t require the liver to activate it. Once swallowed, its small size and lipophilic nature allow it to easily cross the Blood-Brain Barrier (BBB). Once inside the brain’s physiologic pH environment, it spontaneously converts into its active, highly toxic form (MTIC). MTIC forcefully attaches methyl groups to the DNA of rapid-dividing cancer cells (specifically at the O6 and N7 guanine positions). When the cancer cell tries to replicate its DNA, this methylation causes the DNA to shatter, forcing the tumor cell into apoptosis (cell suicide).
• The Glioblastoma Gold Standard (The Stupp Protocol): For newly diagnosed Glioblastoma Multiforme (the most aggressive brain cancer), Temozolomide is globally mandated to be used concurrently with focal radiotherapy, followed by months of maintenance therapy. This protocol is the undisputed global standard of care, meaning massive, predictable procurement volumes from oncology boards.
• MGMT Promoter Methylation Dependency: Tumors that have a “silenced” MGMT gene (which normally repairs the DNA damage caused by Temozolomide) respond spectacularly well to this drug, making it a highly targeted, genetically guided therapy in modern oncology.

Product Composition & Strength

We supply this product as a Precision-Blended Hard Gelatin Capsule, packed in highly secure, child-resistant and moisture-resistant Alu-Alu blister strips or heavy-gauge HDPE bottles. We offer the complete range of strengths required for exact, weight-based (Body Surface Area) oncology dosing.

*Pack Sizes: 1×5 or 1×14 Alu-Alu Blisters / Bottles of 5 or 20 Capsules (Strictly optimized for 5-day and 42-day oncology regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Oncology Procurement Boards, and Neurosurgery Networks.

Manufacturing Authority

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

• Hazardous Cytotoxic (OEB) Containment: Temozolomide is a highly potent, mutagenic, and teratogenic chemotherapy agent. Our manufacturing is executed within strictly isolated, completely dedicated Oncology blocks operating under severe negative pressure with multi-stage HEPA filtration. Powders are handled inside closed-loop barrier isolators to guarantee absolute operator safety and zero cross-contamination.
• Body Surface Area (BSA) Output Reliability: Because dosing is calculated based on the patient’s exact Body Surface Area (BSA), providing the full spectrum of strengths (20mg to 250mg) is mandatory. Our automated encapsulation lines guarantee flawless fill-weight uniformity across all SKUs, preventing fatal toxicity or treatment failure.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe, malignant central nervous system tumors:

• Newly Diagnosed Glioblastoma Multiforme (GBM): Concomitant treatment with radiotherapy, followed by maintenance treatment as monotherapy.
• Refractory Anaplastic Astrocytoma: Treatment of adult patients experiencing disease progression on a drug regimen containing nitrosourea and procarbazine.

Dosage & Administration

Recommended Dosage (Strictly as per Board-Certified Neuro-Oncologist):

• Body Surface Area Dosing: The dose is strictly calculated in mg/m² of body surface area. A standard maintenance dose is 150-200 mg/m² once daily for 5 consecutive days of a 28-day cycle.
• Administration (FASTING RULE & ANTIEMETICS): Temozolomide causes severe nausea and vomiting. It MUST be taken consistently, preferably on an empty stomach (1 hour before a meal) or at bedtime to minimize gastric distress. Pre-medication with strong antiemetics (like Ondansetron) is highly recommended.
• Handling Precautions (HAZARD WARNING): Capsules MUST be swallowed whole with a glass of water. They must never be opened, chewed, or crushed. If a capsule is accidentally opened, avoid inhalation of the powder or contact with skin and mucous membranes.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX EQUIVALENT (Severe Myelosuppression): Temozolomide causes profound, potentially fatal bone marrow suppression (severe thrombocytopenia and neutropenia). Complete blood counts (CBC) must be monitored strictly on Day 22 and Day 29 of every 28-day cycle. Therapy must be delayed or discontinued if absolute neutrophil or platelet counts drop below critical thresholds.
• Pneumocystis Jirovecii Pneumonia (PCP) Risk: Patients receiving concurrent Temozolomide and radiotherapy are at a massively increased risk of developing fatal PCP. Prophylaxis against PCP (usually with Co-trimoxazole) is strictly mandatory for all patients during the concurrent phase.
• Hepatotoxicity: Fatal and severe hepatotoxicity has been reported. Liver function tests (ALT, AST, bilirubin) must be assessed prior to treatment initiation and after each treatment cycle.
• Teratogenicity: Can cause catastrophic fetal harm. Highly effective contraception is required during treatment and for at least 6 months after the final dose.

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 Advanced Oncology and Neurological Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government cancer programs in Africa or a B2B Pharma Marketplace partner for Southeast Asia, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Specialty Medicine Wholesaler receives WHO-GMP certified products at competitive rates.