Medicine
Brineura kit
Brineura kit is a prescription medicine containing Cerliponase alfa, marketed by BioMarin Pharmaceutical, 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 upright in a freezer (-25°C to -15°C) in original carton to protect from…
Key facts
- Active ingredient (INN)
- Cerliponase alfa
- Brand
- Brineura
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- BioMarin Pharmaceutical
- Manufacturer
- BioMarin Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store upright in a freezer (-25°C to -15°C) in original carton to protect from light. Do not freeze. Administration Kit for use with BRINEURA: Store in original carton separately from BRINEURA.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AB17 Cerliponase alfa
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 April 2017
- Identifiers
- RxCUI 1922453, 1922458DailyMed set ID 485ab3c5-0359-4878-872f-2fe1e7df4047NDC 68135-811Application BLA761052
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 kit in 1 carton * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 68135-811-02 | BioMarin Pharmaceutical | 27 April 2017 |
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
Cerliponase alfa is a prescription medicine indicated to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. MedsAcross supplies Cerliponase alfa 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 Cerliponase alfaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Brineura prescribing information (BioMarin Pharmaceutical) · U.S. National Library of Medicine, DailyMed
- Brineura: European public assessment report (EPAR) · European Medicines Agency
Need Brineura kit 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.