Temozolomide capsules, Indian WHO-GMP supply for glioblastoma and anaplastic astrocytoma, with cytotoxic-handling documentation on file.
An oral alkylating agent dosed against body surface area and taken on an empty stomach, temozolomide is the backbone of glioblastoma therapy alongside radiotherapy. 20mg and 100mg capsules from Indian WHO-GMP facilities, supplied to hospital oncology pharmacies and tender desks with the cytotoxic-handling and containment documentation a receiving pharmacy needs to accept the consignment.
Multiple WHO-GMP partner lines · 20mg and 100mg capsules · CTD dossier on file · cytotoxic-handling documentation included.
Active ingredient
Temozolomide, an imidazotetrazine alkylating prodrug. At physiological pH it spontaneously hydrolyses to the active methylating species MTIC, which methylates DNA at several sites; the O6-methylguanine lesion is the one responsible for cytotoxicity, and for the MGMT-related resistance seen in some tumours. No hepatic activation is required, part of why it reaches the central nervous system reliably.
Strengths stocked
20mg and 100mg hard capsules, across 34 catalogue lines and multiple roster brands, including Gliotem, Temoside and Temcad; Temodal / Temodar (Merck & Co / MSD) is the originator reference buyers benchmark against. Dose is built from combinations of the two strengths to match a patient's calculated body-surface-area dose; capsules must not be opened or split.
Indications
Newly diagnosed glioblastoma multiforme, concomitant with radiotherapy and then as adjuvant monotherapy (the Stupp protocol), and refractory anaplastic astrocytoma after a nitrosourea- and procarbazine-containing regimen. Other malignant glioma uses follow destination-country labelling. We supply the oral cytotoxic only, not the radiotherapy planning or delivery.
Storage
Controlled room temperature, 15 to 30°C. Not a cold-chain molecule, but cytotoxic containment and handling precautions apply throughout transit and at the receiving pharmacy regardless of temperature classification.
Shelf life
24 months from manufacture; minimum 18 months at dispatch. Or we won't ship it.
Pack format
Blister strips in a child-resistant, cytotoxic-labelled carton with a destination-language leaflet. Outer shipping carton marked for cytotoxic handling per standard hazard convention; hospital pharmacy pack sizes on request.
Hospital oncology pharmacies, neuro-oncology units and tender desks across the markets we serve.
India is our origin. We do not sell into the Indian market. Temozolomide is exported only.
United Kingdom
Temozolomide is core NHS neuro-oncology pharmacy stock for the Stupp protocol pathway. Where the primary licensed supplier cannot fill scheduled demand, the MHRA Specials / named-patient import route is available, see MHRA Specials. Cytotoxic-handling documentation is supplied with the pre-dispatch pack as standard.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH tender awards and neuro-oncology or haematology-oncology centre purchase orders (NUPCO and Saudi MoH, MoHAP and DHA for the UAE, Kuwait MoH Central Drug Store, MoPH Qatar, MoH Oman, NHRA Bahrain). Central registration and tender documentation prepared with a full CTD dossier.
Nigeria, Kenya, Ghana, South Africa
Public-sector oncology tenders and teaching-hospital neurosurgical-oncology unit supply (NAFDAC for Nigeria, KEMSA for Kenya, FDA Ghana, SAHPRA for South Africa). Glioblastoma treatment capacity is concentrated in a small number of specialist centres in most of these markets, so consignments are typically smaller in volume but need the same full documentation pack as a large tender.
Germany
Supply via licensed importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD dossier and CoPP prepared for BfArM recognition. Named-patient import (Einzelimport) route available where a specific pack is not locally listed.
Capsules that must not be opened, body-surface-area dosing across two strengths, and the documentation trail that actually clears a neuro-oncology tender.
Temozolomide is dosed by body surface area and taken on an empty stomach, at least one hour before or two hours after food, swallowed whole with a full glass of water. Capsules must never be opened, chewed or dissolved: if a capsule is damaged, the contents must not contact skin or mucous membranes, and a cytotoxic spill protocol applies rather than routine disposal. Antiemetic premedication is standard; temozolomide is moderately to highly emetogenic depending on dose and phase of treatment. During the concomitant radiotherapy phase, lymphopenia is common enough that Pneumocystis jirovecii pneumonia prophylaxis is routinely considered, particularly alongside prolonged dexamethasone for cerebral oedema. Myelosuppression is dose-limiting and delayed, with the nadir typically in the fourth week of a cycle, so full blood counts are monitored well past the last dose, not only at the start of the next cycle. Hepatic and renal function are checked before each cycle. No reconstitution step applies to an oral cytotoxic, but personal protective equipment and cytotoxic waste handling still apply to dispensing and to any damaged-capsule event.
The documentation pack a regulator actually asks for.
Temozolomide is a specialist oncology cytotoxic; the regulatory ask is as much about handling and containment evidence as it is about the standard CMC package. Our role is manufacturer-facing: we sit between the Indian WHO-GMP facility and your clinical, regulatory or procurement team.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary included. Capsule content uniformity and dissolution data provided, given the narrow, body-surface-area-calculated dosing this molecule requires.
CoA and MoA, per batch
HPLC assay, related substances, water content, dissolution, uniformity of dosage units, signed by the manufacturer's authorised QC head. Cytotoxic-grade manufacturing controls documented across the batch record.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Notarised copies included in the shipping pack.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards, with the capsule-integrity warning (do not open, crush or chew) and cytotoxic-handling notice prominently set. Artwork QC before print, not after.
Temperature control
Pre-shipment validation on the shipper configuration. Temozolomide ships at controlled room temperature, 15 to 30°C; it is not a cold-chain molecule, but the cytotoxic-containment protocol is validated and logged alongside the temperature record.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market on registration. Periodic Safety Update Reports compiled to ICH E2C. Myelosuppression, opportunistic infection during the concomitant phase, and hepatotoxicity remain the PSUR priority signals for this molecule.
Recurrent glioblastoma and primary CNS lymphoma: the rest of the neuro-oncology shelf.
Temozolomide rarely stands entirely alone once first-line therapy ends. Recurrence protocols and the wider CNS-malignancy pharmacy basket pull in a different set of cytotoxics and biologics.
Bevacizumab
Anti-VEGF monoclonal antibody, a combination and monotherapy option in recurrent glioblastoma after temozolomide-based first-line treatment fails.
Methotrexate
Antifolate cytotoxic; high-dose regimens are the backbone of primary CNS lymphoma, a separate CNS malignancy on the same neuro-oncology formulary.
Rituximab
Anti-CD20 monoclonal antibody, combination partner in primary CNS lymphoma regimens alongside high-dose methotrexate.
Cyclophosphamide
Alkylating agent, the same broad drug class as temozolomide, used in selected CNS lymphoma and paediatric brain-tumour regimens.
Carboplatin
Platinum cytotoxic, used in selected paediatric and recurrent CNS tumour protocols alongside or after temozolomide.
All oncology →
150+ oncology SKUs: cytotoxics, targeted therapy, supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (20mg or 100mg), capsule count, destination market, and whether this is NHS neuro-oncology pharmacy, GCC tender desk, African public-sector or teaching-hospital supply. Flag if cytotoxic-handling documentation needs a specific format for the receiving pharmacy.
- We route to the right line. Multiple WHO-GMP temozolomide lines sit on the M Care roster. Registered-market preference goes to facilities already holding the relevant destination registration.
- Commercial and regulatory offer. FOB or CIF price, dossier status per destination, and the documentation pack you'll receive with the shipment, including cytotoxic-handling and containment certification. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Controlled room-temperature dispatch lane, cytotoxic-shipper protocols followed end-to-end, on-arrival inspection. Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA and dispatch documentation archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration; myelosuppression, opportunistic infection and hepatotoxicity remain the PSUR priority signals.
Temozolomide supply, the specific questions.
What strengths of temozolomide do you supply?
20mg and 100mg hard capsules, across 34 catalogue lines and multiple roster brands including Gliotem, Temoside and Temcad; Temodal / Temodar (Merck & Co / MSD) is the originator reference buyers benchmark against. Dose is built from a combination of the two strengths to match each patient's calculated body-surface-area dose. Capsules must never be opened, crushed or dissolved, they are swallowed whole.
Why must temozolomide capsules not be opened?
Temozolomide is a cytotoxic alkylating agent, and the capsule contents are a direct exposure hazard if they contact skin or mucous membranes. The capsule shell is the containment. If a capsule is damaged in transit or at the pharmacy, standard cytotoxic spill handling applies rather than routine disposal. This is a real, well-established handling requirement, set out clearly on the destination-language pack insert supplied with every consignment.
What indications is temozolomide licensed for?
Newly diagnosed glioblastoma multiforme, given concomitantly with radiotherapy and then continued as adjuvant monotherapy, the regimen commonly known as the Stupp protocol. Also refractory anaplastic astrocytoma, in patients who have already progressed on a nitrosourea- and procarbazine-containing regimen. Other malignant glioma uses follow destination-country labelling; confirm the exact licensed wording against the regulator you are registering with, since indication scope varies at the margins between the FDA, EMA and other authorities.
Does temozolomide need cold-chain transit?
No. Temozolomide capsules are stored and shipped at controlled room temperature, 15 to 30°C, and do not require refrigeration. What the molecule does require, regardless of temperature, is cytotoxic-handling documentation and a containment protocol at every stage; pre-dispatch validation, in-transit record and on-arrival inspection are logged the same way a cold-chain product would be, the variable being controlled rather than cold.
Which markets can you ship temozolomide into?
The UK (NHS neuro-oncology pharmacy supply or named-patient / MHRA Specials route), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers against MoH tender awards, sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa and neighbouring markets) for tender and teaching-hospital supply, Germany under §72 AMG, and other regulated and semi-regulated markets on the M Care roster. We do not supply into India. Full market coverage is at markets.
What documentation is included with a temozolomide consignment?
Every consignment ships with a batch-specific Certificate of Analysis (assay, related substances, dissolution, water content, uniformity of dosage units), Method of Analysis, Certificate of Pharmaceutical Product (CoPP) where required, WHO-GMP certificate, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert carrying the capsule-integrity and cytotoxic-handling warnings, and containment and handling logs from pre-dispatch through on-arrival. PV contact nominated in the destination market on registration.
Do you provide CTD dossiers for temozolomide registration?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central and state-level registration, BfArM, NAFDAC, PPB, SAHPRA and comparable bodies. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. The cytotoxic-handling and containment evidence is prepared as a dossier addendum alongside the standard CMC package. See dossier preparation.
Send the specifics. You'll have a price inside one working day.
Strength, capsule volume, destination, NHS neuro-oncology pharmacy or GCC/African tender, cytotoxic-handling documentation if required. That's the enquiry. Everything else is on us.