Medicine
Brukinsa 80 mg capsule
Brukinsa 80 mg capsule is a prescription medicine containing Zanubrutinib for oral use, marketed by BeOne Medicines, 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 at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Zanubrutinib
- Brand
- Brukinsa
- Strength
- 80 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- BeOne Medicines
- Manufacturer
- BeOne Medicines
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EL03 Zanubrutinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 November 2019
- Identifiers
- RxCUI 2262440, 2262446, 2719220 +1DailyMed set ID 3e08fe23-d70e-424c-bc51-1222e320f902NDC 72579-011Application NDA213217
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 bottle, plastic in 1 carton / 120 capsule in 1 bottle, plastic | 72579-011-02 | BeOne Medicines | 14 November 2019 |
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 Zanubrutinib
Clinical summary
Zanubrutinib is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, among other approved uses. MedsAcross supplies Zanubrutinib 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 ZanubrutinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BRUKINSA prescribing information (BeOne Medicines) · U.S. National Library of Medicine, DailyMed
- Brukinsa: European public assessment report (EPAR) · European Medicines Agency
Need Brukinsa 80 mg capsule 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.