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MedsAcross

Medicine

Aranesp 40 mcg/0.4 mL injection

Darbepoetin alfa · Intravenous, subcutaneous · Amgen
Available on requestPrescription onlyUS FDA Cold chain

Aranesp 40 mcg/0.4 mL injection is a prescription medicine containing Darbepoetin alfa for intravenous, subcutaneous use, marketed by Amgen, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Protect from…

Key facts

Active ingredient (INN)
Darbepoetin alfa
Brand
Aranesp
Strength
40 mcg/0.4 mL
Dosage form
Injection
Route
Intravenous, subcutaneous
Packs
1 blister pack of 0.4 mL
Marketing authorisation holder
Amgen
Manufacturer
Amgen
Origin register
US FDA, United States
Storage
Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Protect from light, store Aranesp in the carton until use.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
B03XA02 Darbepoetin alfa
HS code (indicative)
3002.15Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
14 August 2006
Identifiers
RxCUI 349273, 349274, 349275 +7DailyMed set ID 0fd36cb9-c4f6-4167-93c9-8530865db3f9NDC 55513-021Application BLA103951

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

PackCodeLabelerMarketed since
1 blister pack in 1 package / 4 syringe in 1 blister pack / .4 mL in 1 syringe55513-021-04Amgen14 August 2006

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 17 September 2001Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Other strengths and forms of Darbepoetin alfa

Clinical summary

Darbepoetin alfa is an erythropoiesis-stimulating agent indicated for the treatment of anemia due to chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis, among other approved uses. MedsAcross supplies Darbepoetin alfa for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Darbepoetin alfa

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Aranesp 40 mcg/0.4 mL injection for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.