Medicine
Releuko 480 mcg/0.8 mL injection
Releuko 480 mcg/0.8 mL injection is a prescription medicine containing Filgrastim for intravenous, subcutaneous use, marketed by Amneal Pharmaceuticals, 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store RELEUKO refrigerated at 2°C to 8°C (36°F to 46°F) in the original pack…
Key facts
- Active ingredient (INN)
- Filgrastim
- Brand
- Releuko
- Strength
- 480 mcg/0.8 mL
- Dosage form
- Injection
- Route
- Intravenous, subcutaneous
- Packs
- 1 syringe of 0.8 mL, 10 syringes of 0.8 mL
- Marketing authorisation holder
- Amneal Pharmaceuticals
- Manufacturer
- Amneal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store RELEUKO refrigerated at 2°C to 8°C (36°F to 46°F) in the original pack to protect from light. DO NOT freeze RELEUKO.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L03AA02 Filgrastim
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 February 2022
- Identifiers
- RxCUI 2595944, 2595950, 2595953 +5DailyMed set ID 74e1ec6e-1630-4654-895c-2bd355f939e7NDC 70121-1570Application BLA761082
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 syringe in 1 box / .8 mL in 1 syringe | 70121-1570-1 | Amneal Pharmaceuticals | 25 February 2022 |
| 10 syringe in 1 box / .8 mL in 1 syringe | 70121-1570-7 | Amneal Pharmaceuticals | 25 February 2022 |
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.
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
Alternatives
Other makers and brands of Filgrastim 480 mcg/0.8 mL injection.
- Granix 480 mcg/0.8 mL injectionAvailable on requestCephalonUS FDA4 packs Cold chain
- Zarxio 480 mcg/0.8 mL injectionAvailable on requestSandozUS FDA4 packs Cold chain
- Neupogen 480 mcg/0.8 mL injectionAvailable on requestAmgenUS FDA3 packs Cold chain
- Filkri 480 mcg/0.8 mL injectionAvailable on requestAccord BioPharmaIndiaUS FDA2 packs Cold chain
- Nivestym 480 mcg/0.8 mL injectionAvailable on requestPfizer LaboratoriesUS FDA2 packs Cold chain
Other strengths and forms of Filgrastim
Clinical summary
Filgrastim is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. MedsAcross supplies Filgrastim 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 FilgrastimFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- NEUPOGEN prescribing information (Amgen) · U.S. National Library of Medicine, DailyMed
- Accofil: European public assessment report (EPAR) · European Medicines Agency
- Filgrastim Hexal: European public assessment report (EPAR) · European Medicines Agency
Need Releuko 480 mcg/0.8 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.