Tarceva (erlotinib) is licensed for first-line EGFR mutation-positive metastatic NSCLC and, combined with gemcitabine, for first-line pancreatic cancer, with FDA-approved generic erlotinib now on the market from several manufacturers.
Tarceva (erlotinib hydrochloride), originated by OSI Pharmaceuticals and developed and marketed for many years by Genentech and Roche, is an oral EGFR tyrosine-kinase inhibitor now authorised in the EU under Cheplapharm Registration GmbH. M Care Exports is a merchant exporter: we source both branded Tarceva and FDA-approved generic erlotinib tablets against buyer specification and destination-market registration status, and dispatch on quote, not from our own production line.
Erlotinib exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes erlotinib against buyer specification: brand (Tarceva) or generic, strength (25 mg, 100 mg or 150 mg) and destination-market regulatory documentation. Because a first-line NSCLC order needs prior EGFR-mutation testing to justify at the tender-review stage, and pancreatic-cancer orders are dosed differently and packaged separately from the NSCLC line, we confirm indication and dose at enquiry before we build the quote, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
Epidermal growth factor receptor (EGFR/HER1) tyrosine kinase inhibitor, sourced and documented for export.
Erlotinib hydrochloride is a small-molecule, reversible inhibitor of the epidermal growth factor receptor (EGFR/HER1) tyrosine kinase. It blocks intracellular EGFR autophosphorylation, which slows proliferation in tumours driven by activating EGFR mutations.
The FDA label covers three settings: first-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations; maintenance and post-chemotherapy treatment of locally advanced or metastatic NSCLC after platinum-based first-line therapy; and first-line locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine. Destination-country labelling may narrow or extend this list, so buyers should confirm against their own regulator's approved indications.
Erlotinib is supplied as 25 mg, 100 mg and 150 mg film-coated tablets, taken orally. It is not a cold-chain product; it needs no reconstitution, which keeps freight simple relative to injectable oncology lines on the same order.
Active ingredient
erlotinib hydrochloride. Epidermal growth factor receptor (EGFR/HER1) tyrosine kinase inhibitor.
Forms and strengths
25 mg film-coated tablet; 100 mg film-coated tablet; 150 mg film-coated tablet.
Indications
Oral EGFR tyrosine-kinase inhibitor indicated as first-line therapy for metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) mutations, for NSCLC maintenance and post-chemotherapy use, and, in combination with gemcitabine, for first-line locally advanced or metastatic pancreatic cancer.
Administration
oral. Film-coated tablet.
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 erlotinib are mainly hospital thoracic and hepatobiliary oncology pharmacists running EGFR-tested NSCLC and pancreatic-cancer formularies, national and regional MoH tender desks with an oncology procurement list, licensed pharmaceutical wholesalers and importers serving cancer centres, and NGO or foundation procurement programmes supporting lung-cancer treatment access where EGFR testing infrastructure and erlotinib registration are both in place.
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 erlotinib.
Dosing splits by indication and this drives pack-mix planning. The NSCLC dose is 150 mg orally once daily; the pancreatic-cancer dose, given with gemcitabine, is 100 mg orally once daily. Both are taken at least one hour before or two hours after food, since food materially increases erlotinib bioavailability and the label dose was set on a fasted-state pharmacokinetic profile.
Smoking status matters clinically: current smokers show roughly half the steady-state erlotinib exposure of former or never-smokers, so prescribers often dose-escalate in smokers who tolerate treatment, worth flagging at intake so hospital pharmacies plan dose-reduced and dose-escalated pack mixes rather than a single fixed strength.
Hepatic function needs checking before and during therapy: the label advises against use in patients with total bilirubin above 3 times the upper limit of normal, with dose interruption or reduction for worsening liver tests, since hepatotoxicity, including hepatic failure, has been reported with and without pre-existing hepatic impairment.
Proton pump inhibitors reduce erlotinib exposure meaningfully (omeprazole cuts AUC by around 46%) because erlotinib solubility is pH-dependent, so concomitant PPI use should be avoided where possible and switched to an H2-blocker or antacid with dose-timing separation instead; a common medicines-reconciliation catch worth flagging at dispensing, since gastro-oesophageal reflux is common in this cancer population.
Erlotinib is an oral solid needing no cold chain, which simplifies last-mile freight for GCC and African tender routes compared with the infused agents often co-listed on the same oncology tender.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, erlotinib travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics. What buyers need instead is confirmation of EGFR-mutation testing capability behind an NSCLC order, since the first-line indication is biomarker-restricted, alongside the usual import licence, CoA and batch documentation M Care compiles for every shipment.
On the brand-versus-generic question, Tarceva remains the originator product; OSI Pharmaceuticals originated it, and marketing authorisation has since passed through Genentech, Roche and, in the EU, Cheplapharm Registration GmbH, while the branded FDA listing in the US is currently marked discontinued (not for safety or efficacy reasons) as generic uptake has grown. FDA-approved generic erlotinib hydrochloride tablets from multiple manufacturers, including Mylan/Viatris, Teva, Camber and Alembic, are now separately registered and marketed in the US, so buyers genuinely have a brand-or-generic choice; M Care quotes either against the tender specification and destination-market registration status, since generic approval status, and current brand availability, can differ by country.
Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.
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 erlotinib.
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 erlotinib.
- 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.
Erlotinib supply, the specific questions.
Does a generic version of Tarceva exist?
Yes. FDA-approved generic erlotinib hydrochloride tablets are now registered and marketed in the US from several manufacturers, including Mylan/Viatris, Teva, Camber and Alembic, alongside the originator Tarceva. Registration status for generic erlotinib varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Tarceva to our market?
Yes, on an import basis, where the brand is registered in your market. Tarceva's marketing authorisation now sits with Cheplapharm Registration GmbH in the EU, after originating with OSI Pharmaceuticals and being developed and marketed for many years by Genentech and Roche; the branded FDA listing in the US is currently marked discontinued, though not for safety or efficacy reasons. We source against your import authorisation and destination-market registration requirements and do not manufacture the product ourselves.
What strengths of erlotinib tablets are available?
25 mg, 100 mg and 150 mg film-coated tablets, matching the FDA-labelled Tarceva strengths. The 150 mg strength is the standard NSCLC dose; 100 mg is the standard pancreatic-cancer dose given with gemcitabine. Tell us your dosing protocol and we quote the strength mix accordingly.
Is erlotinib restricted to patients with a specific EGFR mutation?
For first-line metastatic NSCLC, yes: the FDA label restricts that indication to tumours with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, confirmed by an approved test. Maintenance and post-chemotherapy NSCLC use, and the pancreatic-cancer indication with gemcitabine, do not carry the same biomarker restriction. Check destination-country labelling for the exact indication wording your market requires.
Does erlotinib need cold-chain shipping?
No. It is an oral tablet stored at controlled room temperature, so it moves on standard ambient logistics rather than the validated cold-chain lanes M Care uses for biologics and vaccines.
What documentation does M Care provide with an erlotinib shipment?
CTD/eCTD-aligned dossier documentation, certificates of analysis, batch records and CDSCO export paperwork from the Indian side, plus confirmation of your receiving hospital's or importer's registration status 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.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.