Medicine
Udenyca 6 mg/0.6 mL injection
Udenyca 6 mg/0.6 mL injection is a prescription medicine containing Pegfilgrastim for subcutaneous use, marketed by Coherus Oncology, 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 refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect…
Key facts
- Active ingredient (INN)
- Pegfilgrastim
- Brand
- Udenyca
- Strength
- 6 mg/0.6 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.6 mL and 3 more
- Marketing authorisation holder
- Coherus Oncology
- Manufacturers
- Coherus OncologyAccord BioPharmaIndia
- Origin register
- US FDA, United States
- Storage
- Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Avoid freezing, if frozen, thaw in the refrigerator before administration. Store UDENYCA ONBODY in the refrigerator at 2°C to 8°C (36°F to 46°F) until 30 minutes prior to use. Discard UDENYCA stored at room temperature for more than 48 hours.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L03AA13 Pegfilgrastim
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 November 2018
- Identifiers
- RxCUI 2102703, 2102705, 2632544 +3DailyMed set ID 77a8576f-b91e-42ce-b613-2fa3c3d4a571, a8c290ee-b699-4395-a596-1453d4a4b4ebNDC 69448-025, 70114-101, 69448-026 +3Application BLA761039
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 carton / .6 mL in 1 syringe | 70114-101-01 | Coherus Oncology | 2 November 2018 |
| 1 syringe in 1 carton / .6 mL in 1 syringe | 70114-120-01 | Coherus Oncology | 6 March 2023 |
| 1 syringe in 1 carton / .6 mL in 1 syringe | 70114-130-01 | Coherus Oncology | 22 December 2023 |
| 1 syringe in 1 carton / .6 mL in 1 syringe | 69448-025-63 | Accord BioPharmaIndia | 15 December 2025 |
| 1 syringe in 1 carton / .6 mL in 1 syringe | 69448-026-63 | Accord BioPharmaIndia | 23 March 2026 |
| 1 syringe in 1 carton / .6 mL in 1 syringe | 69448-027-63 | Accord BioPharmaIndia | 27 October 2025 |
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 Pegfilgrastim 6 mg/0.6 mL injection.
- Stimufend 6 mg/0.6 mL injectionAvailable on requestFresenius KabiUS FDA2 packs Cold chain
- Armlupeg 6 mg/0.6 mL injectionAvailable on requestLupinIndiaUS FDA1 pack Cold chain
- Fulphila 6 mg/0.6 mL injectionAvailable on requestBiocon BiologicsIndiaUS FDA1 pack Cold chain
- Fylnetra 6 mg/0.6 mL injectionAvailable on requestAmneal PharmaceuticalsUS FDA1 pack Cold chain
- Neulasta 6 mg/0.6 mL injectionAvailable on requestAmgenUS FDA1 pack Cold chain
- Nyvepria 6 mg/0.6 mL injectionAvailable on requestPfizer LaboratoriesUS FDA1 pack Cold chain
Other strengths and forms of Pegfilgrastim
Clinical summary
Pegfilgrastim is a leukocyte growth factor indicated in adult and pediatric patients to Decrease the incidence of infection, as manifested by febrile neutropenia, among other approved uses. It is available as injection and kits for subcutaneous use. MedsAcross supplies Pegfilgrastim 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 PegfilgrastimFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Neulasta prescribing information (Amgen) · U.S. National Library of Medicine, DailyMed
- Neulasta: European public assessment report (EPAR) · European Medicines Agency
- Cavoley: European public assessment report (EPAR) · European Medicines Agency
Need Udenyca 6 mg/0.6 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.