Afinitor and Zortress are both everolimus, but Novartis markets them as separate products for separate uses: Afinitor for oncology and tuberous sclerosis, Zortress for transplant rejection prophylaxis.
Afinitor (oncology, tuberous sclerosis) and Zortress (kidney and liver transplant) share the same active ingredient, everolimus, but carry different strengths, different dose ranges and different monitoring requirements. M Care sources both Novartis brands through licensed Indian distribution channels as a merchant exporter, alongside FDA-approved generic everolimus tablets for the oncology indications. We do not manufacture; we verify, dispatch and document.
Everolimus exporter and bulk supplier from India.
For tender and bulk procurement, M Care separates Afinitor and Zortress orders at the enquiry stage because dosing units, pack configurations and destination-country licensing can differ between the oncology and transplant lines. Hospital pharmacy and MoH tender desks sourcing everolimus for an oncology formulary should specify Afinitor or Afinitor Disperz by strength; transplant programmes should specify Zortress and confirm their local therapeutic drug monitoring (TDM) capability before order confirmation, since Zortress dosing is titrated to blood trough levels rather than a fixed schedule.
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.
mTOR (mammalian target of rapamycin) inhibitor, oral kinase inhibitor, sourced and documented for export.
Everolimus is an oral mTOR (mammalian target of rapamycin) inhibitor. As Afinitor, it is licensed for hormone receptor-positive, HER2-negative advanced breast cancer in combination with exemestane; progressive, unresectable or metastatic pancreatic and gastrointestinal/lung neuroendocrine tumours; advanced renal cell carcinoma after failure of sunitinib or sorafenib; and tuberous sclerosis complex-associated renal angiomyolipoma, subependymal giant cell astrocytoma (SEGA) and partial-onset seizures. As Zortress, the same molecule is licensed for prophylaxis of organ rejection in adult kidney transplant recipients at low-moderate immunologic risk (with basiliximab, reduced-dose cyclosporine and corticosteroids) and in adult liver transplant recipients (with reduced-dose tacrolimus and corticosteroids, started no earlier than 30 days post-transplant).
Afinitor tablets are supplied in 2.5 mg, 5 mg, 7.5 mg and 10 mg strengths; Afinitor Disperz (tablets for oral suspension, for paediatric and dysphagic patients) in 2 mg, 3 mg and 5 mg. Zortress tablets are supplied in 0.25 mg, 0.5 mg, 0.75 mg and 1 mg strengths, reflecting the narrow, trough-guided dose titration used in transplant protocols.
Both products are oral solid dosage forms held at controlled room temperature; neither requires cold-chain handling. Original blister packaging should be kept intact until dosing, as both are moisture- and light-sensitive.
Active ingredient
everolimus. mTOR (mammalian target of rapamycin) inhibitor, oral kinase inhibitor.
Forms and strengths
2.5 mg tablet (Afinitor); 5 mg tablet (Afinitor); 7.5 mg tablet (Afinitor); 10 mg tablet (Afinitor); 2 mg tablet for oral suspension (Afinitor Disperz); 3 mg tablet for oral suspension (Afinitor Disperz); 5 mg tablet for oral suspension (Afinitor Disperz); 0.25 mg tablet (Zortress); 0.5 mg tablet (Zortress); 0.75 mg tablet (Zortress); 1 mg tablet (Zortress).
Indications
Oral mTOR inhibitor marketed as Afinitor/Afinitor Disperz for hormone receptor-positive breast cancer, neuroendocrine tumours, renal cell carcinoma and tuberous sclerosis complex, and as Zortress for prophylaxis of kidney and liver transplant rejection.
Administration
oral. Tablets and tablets for oral suspension (Afinitor/Afinitor Disperz); tablets (Zortress).
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.
Enquiries split by indication. Oncology-side buyers are hospital pharmacies, cancer-centre procurement desks and MoH tender panels sourcing Afinitor or Afinitor Disperz for breast cancer, neuroendocrine tumour and renal cell carcinoma formularies, plus tuberous sclerosis clinics. Transplant-side buyers are hospital transplant units and NHS trust or MoH renal/hepatic transplant programmes sourcing Zortress, typically alongside cyclosporine or tacrolimus and basiliximab on the same order. Licensed importers and wholesalers across our GCC and African markets place both lines under distinct import documentation, since the two brands carry separate registration dossiers in most destination countries.
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 everolimus.
Confirm which brand the requisition means before quoting: 'everolimus' alone is ambiguous. Afinitor for oncology is typically dosed once daily at a fixed strength selected by indication and adjusted for toxicity or hepatic impairment; Afinitor Disperz must be dispersed in water immediately before administration and never swallowed whole or dispersed with other liquids or crushed foods. Zortress, by contrast, uses a starting dose that is then titrated to a whole-blood trough concentration target of 3 to 8 ng/mL measured by LC/MS/MS, with levels checked roughly 4 to 5 days after any dose change or after starting/stopping interacting drugs (cyclosporine and tacrolimus both interact with everolimus exposure).
Because Zortress dosing is TDM-driven, transplant programmes need functioning trough-level assay access before committing to Zortress-based protocols; this is a receiving-hospital capability issue, not something M Care's supply chain resolves. Oncology dosing under Afinitor does not require routine blood-level monitoring, though dose interruption or reduction is common for stomatitis, pneumonitis, hyperglycaemia and other class-typical adverse events.
Both products are strong CYP3A4/P-glycoprotein substrates: strong inhibitors (e.g. ketoconazole) and inducers (e.g. rifampicin) materially change everolimus exposure in either indication, so a full concomitant medication check belongs in every dispensing review, not just at transplant initiation.
Generic everolimus tablets, approved in the US oncology-indication market via ANDA (multiple manufacturers, including Teva, Aurobindo, Natco and others), exist for the Afinitor line; we can source and quote these on request. Zortress-line supply, given the narrow therapeutic index and trough-driven dosing transplant teams use it for, is generally sourced as the Novartis brand; buyers should confirm current generic availability and their own formulary's substitution policy for narrow-therapeutic-index drugs before switching.
The documentation pack a regulator actually asks for.
Everolimus ships as an oral solid, so the documentation chain is the standard small-molecule export file: certificate of analysis and certificate of pharmaceutical product per batch, CDSCO export licensure from the Mumbai desk, and destination-market import permits (MHRA, SFDA, MOHAP, NAFDAC, PPB, SAHPRA or equivalent, depending on market) arranged before dispatch. No cold-chain validation is required; storage and transport stay at controlled room temperature with humidity and light protection maintained through transit.
Brand-versus-generic positioning differs by indication. For Afinitor's oncology indications, FDA-approved ANDA generic everolimus exists and we can quote brand or generic against the same requisition. For Zortress's transplant indications, buyers should treat brand continuity as a clinical decision for their transplant team given the trough-monitored, narrow-therapeutic-index nature of immunosuppression, and confirm current generic status in their own market before requesting a substitution quote. M Care does not manufacture either product; supply runs through licensed Indian distribution channels as a merchant exporter.
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 everolimus.
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 everolimus.
- 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.
Everolimus supply, the specific questions.
Are Afinitor and Zortress the same drug?
Same active ingredient, everolimus, but different Novartis products. Afinitor (plus Afinitor Disperz) is licensed for oncology indications and tuberous sclerosis complex; Zortress is licensed for kidney and liver transplant rejection prophylaxis. They carry different strengths and different dosing logic, so specify the brand and indication when you enquire.
Is there a generic version of everolimus?
For the Afinitor oncology indications, yes: FDA-approved ANDA generic everolimus tablets exist from multiple manufacturers and we can source and quote them alongside the Novartis brand. For the Zortress transplant indications, confirm current generic status and your formulary's narrow-therapeutic-index substitution policy with your transplant team before requesting a generic quote.
Does everolimus need cold-chain shipping?
No. Both Afinitor and Zortress are oral tablets stored and transported at controlled room temperature, kept in original blister packaging and protected from light and moisture. Cold-chain validation is not required for this molecule.
Can M Care supply Afinitor or Zortress to our market?
We supply both as a merchant exporter, sourcing through licensed Indian distribution channels and CDSCO export licensure, with import documentation arranged for the destination country. We do not manufacture either product; confirm your local import and registration requirements with our Mumbai desk when you enquire.
What monitoring does Zortress require that Afinitor doesn't?
Zortress dosing is titrated to a whole-blood everolimus trough concentration target of 3 to 8 ng/mL, checked roughly 4 to 5 days after dose changes. Afinitor's oncology dosing does not require routine trough monitoring, though patients are monitored for class-typical adverse events.
What strengths are available?
Afinitor tablets: 2.5 mg, 5 mg, 7.5 mg, 10 mg. Afinitor Disperz (oral suspension tablets): 2 mg, 3 mg, 5 mg. Zortress tablets: 0.25 mg, 0.5 mg, 0.75 mg, 1 mg. Confirm the exact strength mix against your requisition when you enquire.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-28.
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.