Aranesp (darbepoetin alfa) is a long-acting erythropoiesis-stimulating agent given as a single injection weekly, every two weeks or monthly, and it is bought as the Amgen originator or as an Indian-made version, depending on what the destination registers.
M Care Exports supplies Aranesp (darbepoetin alfa), made by Amgen, and Indian-made darbepoetin alfa such as Cresp, Actorise and Darbotin, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for Aranesp 40 mcg or 100 mcg, send the destination, the presentation and the quantity, and we quote per destination.
Darbepoetin alfa exporter and bulk supplier from India.
"We need a partner for darbepoetin alfa" is a typical renal-unit or tender enquiry. M Care is a merchant-exporter: we quote the Aranesp originator and Indian-made versions against your specification, and the Indian-made lines are offered only for destinations whose registration accepts them. Darbepoetin alfa is a refrigerated biological, so the quote depends on strength, presentation (vial, prefilled syringe or pen), quantity, the registration route and the cold-chain lane. Our catalogue also lists Indian-made lines of this molecule under the names Cresp, Actorise and Darbotin. We do not claim any of them is registered in a given destination. Darbepoetin alfa is a distinct molecule from epoetin alfa, which has its own page on this site.
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.
Erythropoiesis-stimulating agent (ESA), sourced and documented for export.
Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) given by injection. Per the FDA label, Aranesp is indicated for anaemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, and for anaemia due to concurrent myelosuppressive chemotherapy in non-myeloid malignancies when at least two more months of chemotherapy are planned. The EU SmPC lists symptomatic anaemia in chronic renal failure in adults and paediatric patients, and symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. The US label shows single-dose vials of 25, 40, 60, 100 and 200 mcg and prefilled syringes from 10 mcg up to 500 mcg. The EU SmPC lists prefilled syringes, SureClick prefilled pens and vials across strengths from 10 to 500 mcg. The SmPC states that darbepoetin alfa has a longer terminal half-life than r-HuEPO, allowing it to be given less frequently. The US label gives an average subcutaneous half-life of 46 hours in CKD patients on dialysis and 70 hours in those not on dialysis.
Active ingredient
Darbepoetin alfa. Erythropoiesis-stimulating agent (ESA).
Forms and strengths
25 mcg/1 mL single-dose vial; 40 mcg/1 mL single-dose vial; 60 mcg/1 mL single-dose vial; 100 mcg/1 mL single-dose vial; 200 mcg/1 mL single-dose vial; 10 mcg/0.4 mL prefilled syringe; 25 mcg/0.42 mL prefilled syringe; 40 mcg/0.4 mL prefilled syringe; 60 mcg/0.3 mL prefilled syringe; 100 mcg/0.5 mL prefilled syringe; 150 mcg/0.3 mL prefilled syringe; 200 mcg/0.4 mL prefilled syringe; 300 mcg/0.6 mL prefilled syringe; 500 mcg/1 mL prefilled syringe.
Indications
Darbepoetin alfa, a long-acting erythropoiesis-stimulating agent for anaemia in chronic kidney disease and in chemotherapy for non-myeloid malignancies. Sold as Aranesp (Amgen) and supplied alongside Indian-made versions to GCC, African and UK buyers.
Administration
Intravenous, Subcutaneous. Solution for injection in vial, prefilled syringe or prefilled pen.
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 are hospital pharmacists and nephrology or oncology formulary leads, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Aranesp 40 mcg for a dialysis unit" or "We need a partner for darbepoetin alfa for a tender". Each destination has its own registration 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. Renal units buy by presentation and strength, so a 40 mcg syringe and a 100 mcg syringe are separate lines with separate quantities.
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 darbepoetin alfa.
Several points matter on the ward. First, dosing depends on the indication. The US label gives CKD dialysis patients 0.45 mcg/kg once weekly or 0.75 mcg/kg every two weeks, and non-dialysis patients 0.45 mcg/kg every four weeks; chemotherapy anaemia is 2.25 mcg/kg weekly or 500 mcg every three weeks. The label says to use the lowest dose sufficient to reduce the need for red blood cell transfusions. Second, the boxed warning covers death, myocardial infarction, stroke, venous thromboembolism, vascular access thrombosis and tumour progression or recurrence, and in CKD trials patients had greater risks of death, serious cardiovascular reactions and stroke when ESAs targeted haemoglobin above 11 g/dL. Third, handling: do not shake, do not freeze, and protect from light in the carton. Fourth, the EU SmPC allows one removal from the refrigerator for up to seven days at room temperature (up to 25 C) for ambulatory use, then use or discard. The EU SmPC contraindicates poorly controlled hypertension and warns of pure red cell aplasia from neutralising anti-erythropoietin antibodies, mainly with subcutaneous use in CRF. The needle cap of the prefilled syringe and pen contains dry natural rubber, a latex derivative.
The documentation pack a regulator actually asks for.
Darbepoetin alfa is a cold-chain product. The US label sets storage at 2 to 8 C, do not freeze, protect from light, and the EU SmPC gives a shelf life of 3 years, stored in a refrigerator at 2 to 8 C. For a bulk order that means a validated 2 to 8 C lane, in-transit logging and a remaining-shelf-life check on arrival. The originator is made by Amgen: the US BLA 103951 lists Amgen, and the EU marketing authorisation holder is Amgen Europe B.V., authorised on 8 June 2001. A second EU darbepoetin product, Nespo from Dompé Biotec, was authorised the same day and has since been withdrawn (European Commission decision 5 December 2008). M Care documentation covers batch certificates of analysis, CDSCO export documents and destination-aligned dossier support where the regulator requires it. The manufacturer's WHO-GMP status is confirmed per line before quoting.
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 darbepoetin alfa.
Epoetin alfa biosimilar
rhEPO · CKD anaemia (dialysis + pre-dialysis) · chemo-induced anaemia · NHS biosimilar preferred-source · cold-chain biological
Human normal immunoglobulin
Plasma-derived IgG (IVIG, SCIG) · primary immunodeficiency, ITP, CIDP
Eculizumab biosimilar
C5 complement inhibitor · PNH · aHUS · gMG (anti-AChR) · NMOSD (anti-AQP4) · cold-chain biological · meningococcal vaccination mandatory
All haematology & biologicals
The full category listing for procurement desks.
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 darbepoetin alfa.
- 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.
Darbepoetin alfa supply, the specific questions.
What decides the landed price of Aranesp for an importer?
We do not publish prices. The landed cost of darbepoetin alfa depends on whether you choose the Aranesp originator or an Indian-made line, the strength and presentation (vial, prefilled syringe or pen), the quantity, the registration route in your destination, the cold-chain lane and Incoterms. Refrigerated freight is a real cost line for a 2 to 8 C biological. M Care Exports quotes per destination once you send the strength, volume and country.
Is there a generic or biosimilar of Aranesp?
In the US, Drugs@FDA lists Aranesp under BLA 103951, held by Amgen, and we found no other darbepoetin alfa application in FDA data. In the EU, the Aranesp EPAR page names Amgen Europe B.V. as the holder, and the second EU darbepoetin product, Nespo, has been withdrawn. The EMA medicines list we checked shows no darbepoetin alfa biosimilar. In India, our catalogue lists Indian-made darbepoetin alfa such as Cresp, Actorise and Darbotin. M Care supplies both the originator and Indian-made versions, where your regulator accepts them.
Do you supply Aranesp 40 mcg and 100 mcg, and in which presentations?
Yes, we quote both. The US label lists 40 mcg and 100 mcg as single-dose vials (1 mL) and as prefilled syringes (0.4 mL and 0.5 mL). The EU SmPC lists 40 mcg and 100 mcg as prefilled syringes and as SureClick prefilled pens. The EU SmPC restricts the pen to subcutaneous use, and the US label recommends the intravenous route for patients on haemodialysis, so the presentation should match your registration and how the unit doses. Send the presentation, quantity and destination, and we confirm availability.
What is Aranesp indicated for, and what are its uses?
The FDA label lists anaemia due to chronic kidney disease in patients on and not on dialysis, and anaemia due to concurrent myelosuppressive chemotherapy in non-myeloid malignancies when at least two more months of chemotherapy are planned. The EU SmPC lists symptomatic anaemia in chronic renal failure in adults and paediatric patients, and in adult cancer patients on chemotherapy. The US label states it is not indicated where cure is the expected outcome of chemotherapy, or as a substitute for transfusion when immediate correction is needed.
What is the Aranesp dose and how is it given?
Per the US label, CKD dialysis patients receive 0.45 mcg/kg once weekly or 0.75 mcg/kg every two weeks, with the intravenous route recommended for patients on haemodialysis, and non-dialysis patients 0.45 mcg/kg every four weeks. Chemotherapy anaemia is 2.25 mcg/kg weekly or 500 mcg every three weeks, subcutaneously. The EU SmPC states the pre-filled pen is for subcutaneous use only. Doses are adjusted to haemoglobin response, and the US label says to use the lowest dose sufficient to reduce the need for transfusions. The EU SmPC says treatment should be started by a physician experienced in these indications.
What are the side effects of Aranesp?
The EMA lists hypersensitivity and hypertension as the most common side effects in kidney failure patients, and hypersensitivity and oedema in cancer patients. The US boxed warning covers death, myocardial infarction, stroke, venous thromboembolism, vascular access thrombosis and tumour progression or recurrence, and the EU SmPC warns of pure red cell aplasia. Poorly controlled hypertension is a contraindication in the EU. This is a summary for procurement staff, not clinical advice: prescribers should use the full product information for the destination.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
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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