WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Exjade and Jadenu (deferasirox) are Novartis iron chelators for chronic iron overload, sold as tablets for oral suspension, film-coated tablets and granules that are dosed differently, and none of them needs a cold chain.

M Care Exports supplies Exjade and Jadenu (deferasirox), the Novartis brands, to hospital pharmacies, haematology units, importers and tender desks in the GCC, Africa and the UK. If you are looking for Exjade 500 mg tablets for oral suspension, Jadenu film-coated tablets or Jadenu Sprinkle granules, send the destination, the formulation and the quantity, and we quote per destination.

Jadenu 360 mg film-coated tablets pack (deferasirox), Novartis
WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Deferasirox exporter and bulk supplier from India.

"We need a partner for deferasirox" is a typical enquiry from a haematology pharmacy or a tender desk, and the first question is always which formulation. Deferasirox is not one product. The US Exjade label covers tablets for oral suspension of 125, 250 and 500 mg, which are stirred in a liquid and drunk. The US Jadenu label covers film-coated tablets and Jadenu Sprinkle granules, each in 90, 180 and 360 mg, and the Jadenu label states that the dose should be about 30% lower when converting from Exjade. In the UK, the emc lists Exjade as 90, 180 and 360 mg film-coated tablets, and the EMA page for Exjade lists film-coated tablets, dispersible tablets and granules. So "Exjade" means a different tablet depending on the market. M Care is a merchant-exporter: we supply originator or regulator-registered brands and Indian-made lines, confirm the formulation and strength your destination registers, and quote against that. Quotes turn on the product, pack, quantity, registration route and Incoterms. The US labels give room-temperature storage and the UK SmPC states no special storage conditions, so freight is simpler than for refrigerated biologics.

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.

Request a bulk quote → Send a bulk enquiry by form How bulk supply works
At a glance

Iron chelator, sourced and documented for export.

Deferasirox is an iron chelator, and every form on these labels is taken by mouth. The US Exjade label (Novartis Pharmaceuticals Corporation, DailyMed, updated January 2026) gives tablets for oral suspension of 125 mg, 250 mg and 500 mg in bottles of 30. The US Jadenu label (DailyMed, December 2025) gives film-coated tablets and Jadenu Sprinkle granules, each in 90 mg, 180 mg and 360 mg. Both US labels state the indication as chronic iron overload due to blood transfusions in patients 2 years of age and older, and in non-transfusion-dependent thalassaemia syndromes in patients 10 years of age and older, the latter with a liver iron concentration of at least 5 mg Fe/g dry weight and serum ferritin above 300 mcg/L. The EMA page lists Novartis Europharm Limited as holder of the Exjade authorisation, issued on 28 August 2006, and the UK emc lists Novartis Pharmaceuticals UK Limited for the Exjade film-coated tablets, with 1 January 2021 given as the date of first authorisation or renewal. The EU and UK texts word the indications by age and by whether deferoxamine is contraindicated or inadequate. Drugs@FDA lists the US Exjade tablets for suspension as a prescription product in all three strengths, with no discontinued entry.

Active ingredient

Deferasirox. Iron chelator.

Forms and strengths

125 mg tablet for oral suspension (US Exjade); 250 mg tablet for oral suspension (US Exjade); 500 mg tablet for oral suspension (US Exjade); 90 mg film-coated tablet or granules sachet (US Jadenu; UK Exjade tablet); 180 mg film-coated tablet or granules sachet (US Jadenu; UK Exjade tablet); 360 mg film-coated tablet or granules sachet (US Jadenu; UK Exjade tablet).

Indications

Deferasirox is an iron chelator for chronic iron overload due to blood transfusions and, where the label states it, non-transfusion-dependent thalassaemia syndromes. The labels distinguish tablets for oral suspension from film-coated tablets and granules, which are dosed differently.

Administration

Oral. Tablet for oral suspension (US Exjade); film-coated tablet and granules (Jadenu; Exjade film-coated tablet in the UK).

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

Buyers are hospital pharmacists in haematology and thalassaemia services, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Exjade 500 mg tablets for a thalassaemia centre" or "We need a partner for deferasirox film-coated tablets for a tender". Each destination has its own registration or import route, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. M Care supplies both originator or regulator-registered brands and Indian-made lines such as Defrijet, Desirox and Desifer tablets for destinations whose registration accepts them. We do not claim these Indian lines are registered anywhere. Whether a destination needs a registered product or a named-patient import depends on the regulator, and M Care confirms the route per enquiry.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on deferasirox.

Check the formulation before you check the strength, because the same milligram number means a different dose across forms. The Jadenu label states that the dose should be about 30% lower when converting from Exjade: the transfusional starting dose is 14 mg/kg once daily for Jadenu against 20 mg/kg for Exjade, and the UK film-coated SmPC likewise states that a 30% lower dose is needed than for the dispersible tablet. Administration also differs. The US Exjade tablets are not chewed or swallowed whole, are stirred in water, orange juice or apple juice, and are taken on an empty stomach at least 30 minutes before food. Jadenu tablets are swallowed with water or other liquids, on an empty stomach or with a light meal, or, for patients who have difficulty swallowing, crushed and mixed with soft food, and the granules are sprinkled on soft food. Both US labels carry a boxed warning for renal failure, hepatic failure and gastrointestinal haemorrhage. The US Exjade label sets renal and liver monitoring before the start and at set intervals in the first month. Storage on both US labels is 20 to 25 °C, protected from moisture, so no cold chain applies.

Regulatory & quality

The documentation pack a regulator actually asks for.

Deferasirox needs no cold chain on the labels we read. The US Exjade and Jadenu labels give 20 to 25 °C with excursions permitted to 15 to 30 °C and say to protect from moisture. The UK emc SmPC for the film-coated tablets states that no special storage conditions are required and gives a shelf life of 3 years. The WHO Model List (2023), section 10.3 Other medicines for haemoglobinopathies, reads: "deferasirox. Therapeutic alternatives: deferiprone. Tablet (dispersible): 100 mg; 125 mg; 250 mg; 400 mg; 500 mg. Tablet (film-coated): 90 mg; 180 mg; 360 mg." Deferoxamine is listed separately on the Complementary List. M Care documentation covers batch certificates of analysis and export documents, and destination-aligned dossier support where the regulator asks for it. We state the source and status of each line before quoting. Pharmacovigilance contacts follow the registration route in the destination.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for deferasirox.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Deferasirox supply, the specific questions.

What is Exjade 500 mg, and where is it labelled?

The US Exjade label (Novartis Pharmaceuticals Corporation, DailyMed) lists tablets for oral suspension of 125 mg, 250 mg and 500 mg, supplied in bottles of 30. Exjade 500 mg is therefore a US tablet for oral suspension, not a film-coated tablet. The UK emc lists Exjade only as film-coated tablets of 90 mg, 180 mg and 360 mg, so a UK buyer will not find a 500 mg Exjade there. Tell us the formulation and strength your destination registers, and M Care Exports confirms what we can supply against it.

Exjade vs Jadenu: what does the label say is different?

We compare only on label facts and do not recommend either. Exjade in the US is a tablet for oral suspension of 125, 250 or 500 mg, stirred in water, orange juice or apple juice and taken on an empty stomach at least 30 minutes before food. Jadenu in the US is a film-coated tablet or Sprinkle granules of 90, 180 or 360 mg. The tablets are taken with water or other liquids, on an empty stomach or with a light meal, and may be crushed and mixed with soft food for patients who have difficulty swallowing; the granules are sprinkled on soft food. The Jadenu label states that the dose should be about 30% lower when converting from Exjade: the transfusional starting dose of 20 mg/kg/day for Exjade compares with 14 mg/kg/day for Jadenu. Both carry the same boxed warning.

Is there an Exjade generic in the US, EU and UK?

Drugs@FDA lists AB-rated entries for the Exjade tablets for suspension from eight firms. The EMA lists Deferasirox Accord as a generic of Exjade, authorised on 9 January 2020, as film-coated tablets of 90, 180 and 360 mg. The UK emc SmPC for Exjade states that deferasirox is also available as film-coated and dispersible tablets under other tradenames as generic alternatives to Exjade. Which version a destination accepts depends on its regulator, and M Care Exports confirms this per enquiry.

What sets the landed price of Exjade for an importer?

We do not publish prices. The landed cost depends on whether you want the originator Exjade or Jadenu, a regulator-registered generic or an Indian-made line, the formulation and strength, the pack size, the quantity, the registration route in your destination and Incoterms. The labels we read give room-temperature storage or no special storage conditions, so no cold chain is needed. M Care Exports quotes per destination once we have the formulation, strength and quantity.

What is the Exjade dose?

The dose depends on the formulation, so read the label for the product you hold. The US Exjade label gives a starting dose of 20 mg/kg once daily for transfusional iron overload and 10 mg/kg once daily for non-transfusion-dependent thalassaemia. The US Jadenu label gives 14 mg/kg and 7 mg/kg respectively. The UK Exjade film-coated SmPC gives a starting dose of 14 mg/kg/day for transfusional iron overload, with alternative starting doses by transfusion burden, and 7 mg/kg/day for non-transfusion-dependent thalassaemia. Doses are rounded to the nearest whole tablet. Prescribing decisions rest with the treating clinician.

What are the Exjade side effects and monitoring requirements?

Both US labels carry a boxed warning for renal failure, hepatic failure and gastrointestinal haemorrhage. The US Exjade label requires renal function weekly in the first month after starting or changing the dose, then at least monthly, liver tests every 2 weeks in the first month, then at least monthly, and monthly serum ferritin and blood counts. It also requires auditory and ophthalmic testing before the start and at regular intervals. The UK SmPC adds warnings on skin reactions, hypersensitivity, metabolic acidosis and hyperammonaemic encephalopathy. Adverse reaction frequencies are in the full label for the product you supply.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-09.

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.

Deferasirox enquiry

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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.

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