Description

Temozolomide Capsules

Healthy Inc is a specialized global supplier and exporter of advanced antineoplastic and neuro-oncology therapeutics. We provide high-purity Temozolomide Capsules (20 mg / 100 mg / 250 mg), manufactured in WHO–GMP certified, dedicated cytotoxic oral solid dosage facilities. This “Oral Alkylating Agent” is a high-value, mandatory export to comprehensive cancer centers, neuro-oncology departments, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the absolute gold-standard intervention for Glioblastoma Multiforme (GBM) and refractory Anaplastic Astrocytoma.

Product Overview

This formulation contains Temozolomide, an imidazotetrazine derivative and oral prodrug of the alkylating agent MTIC.

The “Blood-Brain Barrier” Specialist:

• Mechanism (DNA Alkylation): Temozolomide is an inactive prodrug. Once absorbed, it undergoes rapid, spontaneous, non-enzymatic hydrolysis at physiological pH to its active compound, MTIC. MTIC rapidly methylates DNA primarily at the O6 and N7 positions of guanine. This catastrophic DNA damage halts the tumor cell cycle and aggressively triggers apoptosis (programmed cell death) in rapidly dividing cancer cells.
• Elite CNS Penetration: Unlike the vast majority of traditional chemotherapy agents which cannot reach the brain, Temozolomide is highly lipophilic and has a low molecular weight. It crosses the Blood-Brain Barrier (BBB) with exceptional efficiency, achieving therapeutic concentrations directly within the cerebrospinal fluid (CSF) and central nervous system tissues.
• The “Stupp Protocol” Backbone: For newly diagnosed Glioblastoma, Temozolomide is the foundational chemotherapeutic backbone, administered concurrently with focal radiotherapy and followed by adjuvant maintenance therapy, drastically improving median survival rates.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in highly secure, moisture-resistant Alu-Alu blisters or specialized child-resistant, amber glass/HDPE bottles designed for safe cytotoxic dispensing.

*Pack Sizes: 1×5 or 1×14 Alu-Alu Blisters (Capsules are precisely counted to match strict Body Surface Area (BSA) oncology protocols).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Oncology Distributors.

Manufacturing Authority

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

• Dedicated Cytotoxic Isolation: Temozolomide is highly potent and toxic. It is manufactured in a 100% isolated, negative-pressure cytotoxic manufacturing block utilizing advanced barrier isolators. This protects operators from aerosolized exposure and guarantees absolute zero cross-contamination with non-oncology pharmaceutical lines.
• Acidic Micro-Environment Stabilization: Because Temozolomide is rapidly converted to its active (but highly unstable) MTIC form at physiological pH, our formulation incorporates tartaric acid as a stabilizing excipient to maintain an acidic micro-environment within the capsule, preserving the API’s integrity until it reaches the absorptive sites of the GI tract.

Therapeutic Indications (Human Use)

Indicated for the treatment of aggressive malignant gliomas:

• Glioblastoma Multiforme (GBM): Treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
• Anaplastic Astrocytoma: Treatment of refractory anaplastic astrocytoma in patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

Dosage & Administration

Recommended Dosage (Strictly as per Neuro-Oncologist):

• Administration (CRITICAL FOOD RULE): Must be taken orally, fasting, at least one hour before a meal or at bedtime. Taking it on an empty stomach significantly reduces the severe incidence of chemotherapy-induced nausea and vomiting (CINV).
• BSA Dosing: Dosing is highly specific and calculated based on the patient’s Body Surface Area (mg/m²).
• Strict Cytotoxic Handling Protocol: Capsules MUST be swallowed whole with a full glass of water. They must never be opened, crushed, or chewed. If a capsule is accidentally damaged, the highly toxic powder must not come into contact with the skin or mucous membranes.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Severe Myelosuppression): Causes profound, life-threatening myelosuppression (thrombocytopenia and neutropenia). Frequent complete blood counts (CBCs) are mandatory. Therapy must be suspended or dose-reduced if absolute neutrophil counts or platelet counts drop dangerously low.
• Pneumocystis Jirovecii Pneumonia (PCP) Risk: Patients receiving Temozolomide concurrently with radiotherapy are at exceedingly high risk for PCP. Prophylaxis against PCP (typically with Sulfamethoxazole/Trimethoprim) is absolutely mandatory during the concomitant phase.
• Hepatotoxicity & Teratogenicity: Severe, sometimes fatal, hepatotoxicity has been reported. Temozolomide is highly teratogenic; strict, highly effective contraception must be utilized by both male and female patients during therapy and for months afterward.

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 Antineoplastic and Oncology 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 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.