Osimertinib is prescribed against a confirmed EGFR mutation and disease stage, not against a general non-small-cell lung cancer diagnosis, and each of its approved settings carries its own testing requirement.
Osimertinib (Tagrisso) is not prescribed for non-small-cell lung cancer generally: it is prescribed against a specific EGFR mutation result, confirmed by an FDA-approved tissue or plasma test, and against one of four distinct approved settings, first-line metastatic disease, adjuvant therapy after resection, unresectable Stage III disease after chemoradiation, or T790M-positive disease that has progressed on an earlier EGFR inhibitor. M Care Exports sources osimertinib for regulatory affairs teams and tender desks who already know which of those four applies.
Osimertinib exporter and bulk supplier from India.
Export documentation for osimertinib follows standard oncology-product practice: certificate of pharmaceutical product or free sale certificate from the country of manufacture, certificate of analysis per batch, GMP certificate for the manufacturing site, and a packing list confirming carton count and batch traceability. Because osimertinib is a solid oral tablet, no cold chain is required, but shipments still move under controlled ambient conditions with humidity-protective blister and carton packaging suited to tropical and Gulf transit routes. M Care prepares the documentation set to match the buyer's own registered label and destination import file, since the reference brand and any generic line can carry different registration histories in different markets. Availability of a specific strength or line is confirmed at enquiry.
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.
Third-generation EGFR tyrosine kinase inhibitor (antineoplastic agent), sourced and documented for export.
Osimertinib's label is built around a companion diagnostic result, not a dose. The molecule is a third-generation, oral EGFR tyrosine kinase inhibitor developed to remain active against the EGFR T790M resistance mutation that limits first- and second-generation inhibitors such as gefitinib, erlotinib and afatinib. Regulators approved it for four separate clinical settings, each requiring its own mutation confirmation: first-line metastatic disease with EGFR exon 19 deletion or exon 21 L858R, adjuvant therapy after complete tumor resection, unresectable Stage III disease following chemoradiation, and T790M-positive disease relapsing on an earlier-generation TKI. Clinical trial data also show materially better central nervous system disease control than earlier-generation inhibitors, a factor tender specifications increasingly name directly. Available as 40 mg and 80 mg film-coated tablets, taken once daily.
Active ingredient
Osimertinib (as osimertinib mesylate). Third-generation EGFR tyrosine kinase inhibitor (antineoplastic agent).
Forms and strengths
40 mg; 80 mg.
Indications
Osimertinib is an oral, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor indicated for EGFR exon 19 deletion or exon 21 L858R mutation-positive non-small cell lung cancer (first-line metastatic, adjuvant post-resection, and unresectable Stage III post-chemoradiation settings) and for EGFR T790M mutation-positive metastatic non-small cell lung cancer that has progressed on or after an earlier EGFR tyrosine kinase inhibitor, as detected by an FDA-approved companion diagnostic test run on tumor tissue or plasma.
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 osimertinib are almost always oncology-specific: hospital pharmacy and tender desks at cancer centres, national and regional cancer-treatment procurement bodies, and licensed pharmaceutical importers and distributors serving oncology channels, across the UK and EU, the Gulf and wider GCC, Africa, Latin America, Southeast Asia and the CIS states. Because dispensing depends on a confirmed EGFR mutation result, enquiries typically come from regulatory affairs and clinical procurement staff who already hold the diagnostic pathway and treatment-line information, rather than general wholesale buyers. Named-patient and parallel-import routes are common where the reference brand is not locally registered, and M Care supports that route where it is the normal path.
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 osimertinib.
A reviewing pharmacist checks that the EGFR mutation result driving the order, exon 19 deletion, exon 21 L858R, or T790M, matches the indication and treatment line stated on the tender or import file, since osimertinib's approved settings (first-line metastatic, adjuvant, unresectable Stage III post-chemoradiation, and T790M-relapsed) are not interchangeable. The FDA-approved companion diagnostic accepts either tumor tissue or plasma-based circulating tumor DNA when tissue is not evaluable, and the testing method used should be recorded against the batch. Osimertinib is a CYP3A4/5 substrate and a weak CYP3A4 inducer, and separately a substrate of P-glycoprotein and BCRP (osimertinib itself inhibits BCRP but not P-glycoprotein), so a pharmacist flags co-administered strong CYP3A4 inducers or inhibitors, narrow-therapeutic-index P-glycoprotein or BCRP substrates, and any QTc-prolonging comedication for dose review. Baseline and periodic ECG and electrolyte monitoring, left ventricular ejection fraction assessment in patients with cardiac risk factors, and prompt ophthalmology referral for keratitis symptoms are standard checks. Interstitial lung disease and pneumonitis carry a boxed warning: the label requires permanent discontinuation on diagnosis, with a Grade 2 or above threshold applying specifically to patients who received recent definitive chemoradiation before starting osimertinib, and discontinuation on any-grade diagnosis for other patients. Pregnancy status is verified before initiation given documented embryo-fetal toxicity.
The documentation pack a regulator actually asks for.
Each osimertinib shipment is supported by a certificate of analysis specific to the batch, a certificate of pharmaceutical product or free sale certificate issued for the country of manufacture, and a current GMP certificate for the manufacturing site, since M Care Exports is a merchant-exporter and sources from WHO-GMP certified Indian manufacturers rather than manufacturing itself. Buyers should independently confirm that the manufacturing site and product registration match their own national regulator's requirements, as registration status for both the reference brand and any generic osimertinib mesylate line varies by destination market and can change. Because dispensing is tied to a specific EGFR mutation and disease-stage indication, regulatory affairs teams typically request the approved label matching their own jurisdiction (FDA, EMA or the relevant national authority) alongside the manufacturer's documentation, to confirm the indication wording, the accepted companion diagnostic testing method, and the safety information their own market requires before filing. M Care Exports holds ISO 9001:2015 certification and a CDSCO export licence; it does not hold, and does not claim, WHO-GMP or WHO-PQ certification in its own name.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Prescription-only oncology medicine; dispensing requires confirmation of EGFR exon 19 deletion, exon 21 L858R, or T790M mutation status via an FDA-approved companion diagnostic run on tissue or plasma
Interstitial lung disease and pneumonitis carry a boxed warning; permanent discontinuation is required on diagnosis, with a Grade 2 or above threshold applying specifically to patients who received recent definitive chemoradiation before starting osimertinib, and discontinuation on any-grade diagnosis for other patients; a minority of cases have been fatal
QTc interval prolongation; ECG and electrolyte monitoring required in at-risk patients or those on QTc-prolonging comedications
Cardiomyopathy reported; left ventricular ejection fraction assessment required in patients with cardiac risk factors
Keratitis; prompt ophthalmology referral required for symptomatic patients
Embryo-fetal toxicity; pregnancy verification and effective contraception required during treatment and after the final dose
Adjacent lines procurement desks order alongside osimertinib.
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 osimertinib.
- 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.
Osimertinib supply, the specific questions.
Which EGFR mutations does osimertinib target, and how is that confirmed before an order is placed?
Osimertinib is active against EGFR exon 19 deletion and exon 21 L858R mutations, and against the EGFR T790M resistance mutation that develops in patients relapsing on an earlier-generation EGFR inhibitor. Mutation status is confirmed using an FDA-approved companion diagnostic, run on either tumor tissue or plasma-based circulating tumor DNA when tissue is not evaluable, and that result should match the indication stated on the buyer's tender or import file.
What clinical settings does the approved label actually cover?
Four distinct settings: first-line treatment of metastatic EGFR-mutated NSCLC, adjuvant therapy after complete tumor resection, unresectable Stage III disease that has not progressed after chemoradiation, and metastatic T790M-positive disease that has progressed on an earlier EGFR inhibitor. Each setting has its own pivotal trial and label wording, so buyers should confirm which one applies before finalising an order.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and sources osimertinib from WHO-GMP certified Indian manufacturers. M Care's own credentials are ISO 9001:2015 certification and a CDSCO export licence. Manufacturing-site GMP status, and WHO-PQ status where applicable, is documented per batch and per manufacturer, not claimed by M Care itself.
Can M Care supply the reference brand Tagrisso, generic osimertinib, or both?
M Care can source both branded and generic osimertinib lines, in the strengths and presentations that are genuinely registered and marketed, since it works across manufacturer networks rather than holding its own production. The specific brand or generic line available for a given destination market is confirmed at enquiry, against the buyer's own registered label and import file.
What is the main safety signal a buyer or importing pharmacist should know?
Interstitial lung disease and pneumonitis carry a boxed warning on the osimertinib label: it requires permanent discontinuation on diagnosis, with a Grade 2 or above threshold applying specifically to patients who received recent definitive chemoradiation before starting treatment, and discontinuation on any-grade diagnosis for other patients. Cardiomyopathy, QTc prolongation and keratitis are also labelled precautions, alongside documented embryo-fetal toxicity requiring pregnancy verification and contraception during treatment. These are standard oncology-label constraints buyers already build into their own dispensing protocols.
What documentation accompanies an osimertinib shipment?
A batch-specific certificate of analysis, a certificate of pharmaceutical product or free sale certificate from the country of manufacture, a current GMP certificate for the manufacturing site, and a packing list with batch traceability. M Care matches this documentation set to the buyer's own registered label and destination import file, since registration history differs between the reference brand and generic lines.
Does patent status affect where M Care can supply osimertinib?
Patent and exclusivity status for osimertinib differs by country and changes over time, so it affects whether a market has a locally registered generic line or originator-only supply. This is a matter for the buyer's own regulatory and legal review. M Care sources according to what is actually registered and available in the destination market at enquiry, including named-patient and parallel-import routes where that is the normal access path.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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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