Medicine
Ebanga 400 mg/8 mL powder for injection
Ebanga 400 mg/8 mL powder for injection is a prescription medicine containing Ansuvimab for intravenous use, marketed by Emergent BioDefense Operations Lansing, 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 2ºC to 8ºC (36ºF to 46ºF) in the original carton to…
Key facts
- Active ingredient (INN)
- Ansuvimab
- Brand
- Ebanga
- Strength
- 400 mg/8 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 carton, 4 cartons, 8 cartons
- Marketing authorisation holder
- Emergent BioDefense Operations Lansing
- Manufacturer
- Emergent BioDefense Operations Lansing
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze. Do not shake. Prior to reconstitution, allow EBANGA vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for approximately 20 minutes.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J06BD04 Ansuvimab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 December 2020
- Identifiers
- RxCUI 2472156, 2472161DailyMed set ID de220c8f-ffcb-4522-a6a2-c7d6ce5de1b5NDC 71655-578Application BLA761172
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 carton in 1 box / 36 vial, glass in 1 carton / 8 mL in 1 vial, glass | 71655-578-03 | Emergent BioDefense Operations Lansing | 21 December 2020 |
| 4 carton in 1 box / 36 vial, glass in 1 carton / 8 mL in 1 vial, glass | 71655-578-04 | Emergent BioDefense Operations Lansing | 21 December 2020 |
| 8 carton in 1 box / 36 vial, glass in 1 carton / 8 mL in 1 vial, glass | 71655-578-08 | Emergent BioDefense Operations Lansing | 21 December 2020 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 21 December 2020 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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
Clinical summary
Ansuvimab is a zaire ebolavirus glycoprotein-directed antibody indicated for the treatment of infection caused by Orthoebolavirus zairense (formerly Zaire ebolavirus) in adult and pediatric patients, among other approved uses. MedsAcross supplies Ansuvimab 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 AnsuvimabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ebanga prescribing information (Emergent BioDefense Operations Lansing) · U.S. National Library of Medicine, DailyMed
Need Ebanga 400 mg/8 mL powder for 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.