Medicine
Hepcludex 8.5 mg powder for injection
Hepcludex 8.5 mg powder for injection is a prescription medicine containing Bulevirtide for subcutaneous use, marketed by Gilead Sciences, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store HEPCLUDEX vials at room temperature between 68 °F to 77 °F (20 °C to 25…
Key facts
- Active ingredient (INN)
- Bulevirtide
- Brand
- Hepcludex
- Strength
- 8.5 mg
- Dosage form
- Powder for injection
- Route
- Subcutaneous
- Packs
- 30 vials
- Marketing authorisation holder
- Gilead Sciences
- Manufacturer
- Gilead Sciences
- Origin register
- US FDA, United States
- Storage
- Store HEPCLUDEX vials at room temperature between 68 °F to 77 °F (20 °C to 25 °C), excursions permitted from 59 °F to 86 °F (15 °C to 30 °C).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05A Direct acting antiviral
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 May 2026
- Identifiers
- RxCUI 2743611, 2743617DailyMed set ID 12391cc2-38c2-4cf5-86d3-2be9370127fcNDC 61958-3104Application BLA761468
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 |
|---|---|---|---|
| 30 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose | 61958-3104-1 | Gilead Sciences | 22 May 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.
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
Bulevirtide is a prescription medicine indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. It is available as powder for injection for subcutaneous use. MedsAcross supplies Bulevirtide 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 BulevirtideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- HEPCLUDEX prescribing information (Gilead Sciences) · U.S. National Library of Medicine, DailyMed
- Hepcludex: European public assessment report (EPAR) · European Medicines Agency
Need Hepcludex 8.5 mg 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.