Iressa (gefitinib) is licensed as first-line treatment for metastatic non-small-cell lung cancer with EGFR exon 19 deletion or exon 21 L858R mutations, and licensed generic gefitinib now sits alongside it across many of our markets.
M Care Exports supplies Iressa (gefitinib), AstraZeneca's EGFR tyrosine-kinase inhibitor, and licensed generic gefitinib to hospital pharmacies, importers and tender desks. Both require confirmed EGFR mutation status before dispatch: we quote brand or generic 250mg tablets against the buyer's prescribing protocol and destination-market registration, not from our own manufacturing.
Gefitinib exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes gefitinib 250mg tablets against buyer specification: brand (Iressa) or licensed generic, pack quantity and destination-market regulatory documentation. Because gefitinib is only appropriate where a patient's tumour has tested positive for an EGFR exon 19 deletion or exon 21 L858R substitution on an approved companion diagnostic, we ask the buyer to confirm their testing pathway is in place, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements before we release stock.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
First-generation EGFR (epidermal growth factor receptor) tyrosine-kinase inhibitor, sourced and documented for export.
Gefitinib is a first-generation, selective EGFR (epidermal growth factor receptor) tyrosine-kinase inhibitor. It blocks the signalling that drives tumour growth in EGFR-mutant non-small-cell lung cancer, and it is taken as a tablet rather than infused, which is a real logistics difference against the cytotoxic agents on the rest of our oncology roster.
Its FDA-labelled indication is first-line treatment of metastatic non-small-cell lung cancer (NSCLC) whose tumours carry an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation, confirmed by an FDA-approved companion diagnostic test before treatment starts. Destination-country labelling may authorise gefitinib more broadly across lines of therapy for the same mutation-positive population, so buyers should check their own regulator's approved label for the full indication wording.
Gefitinib is supplied as 250mg film-coated tablets, dosed at one tablet orally once daily with or without food. It needs no reconstitution and is not a cold-chain product, which simplifies freight against the injectable cytotoxics we also carry.
Active ingredient
gefitinib. First-generation EGFR (epidermal growth factor receptor) tyrosine-kinase inhibitor.
Forms and strengths
250 mg film-coated tablet.
Indications
Oral EGFR tyrosine-kinase inhibitor indicated as first-line treatment of metastatic non-small-cell lung cancer whose tumours carry an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation, confirmed by an approved companion diagnostic.
Administration
oral. Film-coated tablet, 250mg.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for gefitinib are chiefly thoracic and medical oncology units in hospitals running EGFR mutation-testing pathways, national and regional MoH tender desks with lung-cancer treatment lists, licensed pharmaceutical wholesalers and importers serving cancer centres, and NGO or foundation procurement programmes supporting targeted-therapy access where EGFR testing capacity exists locally.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on gefitinib.
Gefitinib is dosed at 250mg orally once daily, taken continuously until disease progression or unacceptable toxicity; a missed dose should not be taken if it falls within 12 hours of the next scheduled dose. For patients unable to swallow tablets, the label permits dispersing a tablet in roughly 4-8 ounces (about 120-240mL) of non-carbonated water, stirred for around 15 minutes and taken immediately, or given by naso-gastric tube. Renal impairment needs no dose adjustment, since under 4% of the drug is renally excreted, but hepatic impairment warrants close monitoring and gefitinib should be withheld or discontinued for Grade 2 or higher ALT/AST elevation or confirmed severe hepatic impairment. The label also carries an interstitial lung disease (ILD) warning: withhold for worsening respiratory symptoms and discontinue if ILD is confirmed. Because eligibility turns entirely on a positive EGFR exon 19 deletion or L858R result from an approved companion diagnostic, we ask the receiving pharmacy to confirm their testing pathway before we release stock rather than dispatch against a bare prescription.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, gefitinib travels on standard ambient-temperature logistics rather than the validated cold-chain lanes we run for biologics. What buyers need instead is confirmation of their EGFR-testing pathway, since both the FDA and EMA labels restrict use to mutation-confirmed patients, alongside the usual import licence, CoA and batch documentation M Care compiles for every shipment.
On the brand-versus-generic question, Iressa remains AstraZeneca's originator product. Generic gefitinib has reached several of our core markets: the FDA has approved generic 250mg gefitinib tablets in the US, including a Teva-marketed line, and Sandoz launched a generic gefitinib across 13 EU countries in 2018 at loss of patent exclusivity. A separately EU-authorised Mylan/Viatris generic was later withdrawn from the market for commercial reasons in 2024 and is no longer available, so buyers should not assume it is current. Registration status still varies by destination country, so M Care checks local approval status before quoting brand or generic against a specific tender.
For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside gefitinib.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for gefitinib.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Gefitinib supply, the specific questions.
Does a generic version of Iressa exist?
Yes, though availability varies by market. The FDA has approved generic gefitinib 250mg tablets in the US, including a Teva-marketed line, and Sandoz launched a generic gefitinib across 13 EU countries in 2018 at loss of patent exclusivity. A separate EU-authorised Mylan/Viatris generic gefitinib was withdrawn from the market for commercial reasons in 2024, so it is no longer available there. M Care checks current local approval before quoting brand or generic against a specific tender.
Can M Care supply Iressa to our market?
Yes, on an import basis. We source Iressa through AstraZeneca's licensed Indian distribution channels, or a licensed generic where that better matches your tender specification, and dispatch against your import authorisation and confirmed EGFR-testing pathway.
What strength of gefitinib tablets are available?
250mg film-coated tablets, matching the labelled Iressa strength and dose. It is dosed as one tablet orally once daily, so a single strength covers standard prescribing.
Who is gefitinib licensed for?
Its FDA-labelled indication is first-line treatment of metastatic non-small-cell lung cancer whose tumours carry an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation, confirmed by an approved companion diagnostic before treatment starts. Check your destination regulator's approved label for the exact indication wording, since some markets authorise use more broadly across lines of therapy for the same mutation-positive population.
Does gefitinib need cold-chain shipping?
No. It is an oral tablet stored at controlled room temperature (20-25C), so it moves on standard ambient logistics rather than the validated cold-chain lanes we use for biologics and injectable cytotoxics.
What documentation does M Care provide with a gefitinib shipment?
CTD/eCTD-aligned dossier documentation, certificates of analysis, batch records and CDSCO export paperwork from the Indian side, plus confirmation that the receiving centre's EGFR-testing pathway and import authorisation are in order before dispatch.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-11.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
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