Medicine
Brixadi 16 mg/0.32 mL injection
Brixadi 16 mg/0.32 mL injection is a prescription medicine containing Buprenorphine for subcutaneous use, marketed by Braeburn, 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 BRIXADI at room temperature at 20°C to 25°C (68°F to 77° F), with…
Key facts
- Active ingredient (INN)
- Buprenorphine
- Brand
- Brixadi
- Strength
- 16 mg/0.32 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.32 mL
- Marketing authorisation holder
- Braeburn
- Manufacturer
- Braeburn
- Origin register
- US FDA, United States
- Storage
- Store BRIXADI at room temperature at 20°C to 25°C (68°F to 77° F), with excursions permitted at 15°C to 30° C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIII
- ATC code
- N02AE01 Buprenorphine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 June 2023
- Identifiers
- RxCUI 2639021, 2639027, 2639029 +7DailyMed set ID 5d8a8fd0-8619-422a-a664-d1d2e8970f48NDC 58284-216Application NDA210136
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 syringe, glass in 1 carton / .32 mL in 1 syringe, glass | 58284-216-01 | Braeburn | 6 June 2023 |
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 Buprenorphine
Clinical summary
Buprenorphine is a partial opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, among other approved uses. MedsAcross supplies Buprenorphine 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 BuprenorphineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Buprenorphine prescribing information (Rhodes Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Buprenorphine Neuraxpharm: European public assessment report (EPAR) · European Medicines Agency
- Buvidal: European public assessment report (EPAR) · European Medicines Agency
Need Brixadi 16 mg/0.32 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.