Medicine
Gobarden 100 mg/4 mL injection
Gobarden 100 mg/4 mL injection is a prescription medicine containing Bendamustine for intravenous use, marketed by Avyxa Pharma, 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 GOBARDEN in refrigerator, 2°C to 8°C (36°F to 46°F). Retain in original…
Key facts
- Active ingredient (INN)
- Bendamustine
- Brand
- Gobarden
- Strength
- 100 mg/4 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 4 mL
- Marketing authorisation holder
- Avyxa Pharma
- Manufacturer
- Avyxa Pharma
- Origin register
- US FDA, United States
- Storage
- Store GOBARDEN in refrigerator, 2°C to 8°C (36°F to 46°F). Retain in original carton until time of use to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01AA09 Bendamustine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 September 2026
- Identifiers
- RxCUI 1726097, 2754334DailyMed set ID 353fdf70-2720-41d3-a6fc-7baf0d793282NDC 83831-176Application NDA219014
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 in 1 carton / 4 mL in 1 vial | 83831-176-04 | AVYXA Pharma | 25 September 2026 |
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 20 March 2008 | 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
Alternatives
Other makers and brands of Bendamustine 100 mg/4 mL injection.
- Vivimusta 100 mg/4 mL injectionAvailable on requestAzurity PharmaceuticalsUS FDA2 packs Cold chain
- Belrapzo 100 mg/4 mL injectionAvailable on requestEagle PharmaceuticalsUS FDA1 pack Cold chain
- Bendamustine 100 mg/4 mL injectionAvailable on request—US FDA1 pack Cold chain
- Bendeka 100 mg/4 mL injectionAvailable on requestTeva PharmaceuticalsUS FDA1 pack Cold chain
Other strengths and forms of Bendamustine
Clinical summary
Bendamustine is an alkylating drug indicated for treatment of patients with chronic lymphocytic leukemia (CLL), among other approved uses. It is available as powder for injection and injection for intravenous use. MedsAcross supplies Bendamustine 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 BendamustineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TREANDA prescribing information (Cephalon) · U.S. National Library of Medicine, DailyMed
Need Gobarden 100 mg/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.