Medicine
Heplisav-b injection
Heplisav-b injection is a prescription medicine containing Hepatitis b vaccine (recombinant) adjuvanted for intramuscular use, marketed by Bamboo US BidCo, 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
Storage as on the product label
Key facts
- Active ingredient (INN)
- Hepatitis b vaccine (recombinant) adjuvanted
- Brand
- Heplisav-b
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 5 syringes
- Marketing authorisation holder
- Bamboo US BidCo
- Manufacturers
- Bamboo US BidCoA-S Medication SolutionsDynavax Technologies
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.41Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 January 2018
- Identifiers
- NDC 50090-4526, 43528-003, 83703-048Application BLA125428
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 |
|---|---|---|---|
| 5 syringe in 1 carton / .5 mL in 1 syringe | 83703-048-05 | Bamboo US BidCo | 1 January 2018 |
| 5 syringe in 1 carton / .5 mL in 1 syringe | 43528-003-05 | Dynavax Technologies | 1 January 2018 |
| 5 syringe in 1 carton / .5 mL in 1 syringe | 50090-4526-0 | A-S Medication Solutions | 1 January 2018 |
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 |
| 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
Clinical information for Hepatitis b vaccine (recombinant) adjuvanted is on its overview page.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Hepatitis b vaccine (recombinant) adjuvantedFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- US FDA NDC directory · Checked 12 November 2026
Need Heplisav-b 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.