Medicine
Epkinly 48 mg/0.8 mL injection
Epkinly 48 mg/0.8 mL injection is a prescription medicine containing Epcoritamab for subcutaneous use, marketed by Genmab, 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 at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep in the…
Key facts
- Active ingredient (INN)
- Epcoritamab
- Brand
- Epkinly
- Strength
- 48 mg/0.8 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial of 0.8 mL
- Marketing authorisation holder
- Genmab
- Manufacturer
- Genmab
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep in the original carton to protect from light. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FX27 Epcoritamab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 May 2023
- Identifiers
- RxCUI 2637399, 2637405, 2637408 +1DailyMed set ID d7836711-b677-412d-bf2d-0f7c8444103aNDC 82705-010Application BLA761324
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 vial, glass in 1 carton / .8 mL in 1 vial, glass | 82705-010-01 | Genmab | 19 May 2023 |
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
Other strengths and forms of Epcoritamab
Clinical summary
Epcoritamab is a bispecific CD20-directed CD3 T cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, among other approved uses. MedsAcross supplies Epcoritamab 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 EpcoritamabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- EPKINLY prescribing information (Genmab) · U.S. National Library of Medicine, DailyMed
- Tepkinly: European public assessment report (EPAR) · European Medicines Agency
Need Epkinly 48 mg/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.