Medicine
Byfavo 2.5 mg/mL powder for injection
Byfavo 2.5 mg/mL powder for injection is a prescription medicine containing Remimazolam for intravenous use, marketed by Acacia Pharma, 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 controlled room temperature 20°C to 25°C (68°F to 77°F) excursions…
Key facts
- Active ingredient (INN)
- Remimazolam
- Brand
- Byfavo
- Strength
- 2.5 mg/mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 10 vials
- Marketing authorisation holder
- Acacia Pharma
- Manufacturer
- Acacia Pharma
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°C to 25°C (68°F to 77°F) excursions between 15° and 30°C (59° and 86°F) are allowed. Reconstituted BYFAVO can be stored in the vial for up to 8 hours under controlled room temperature at 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N05CD14 Remimazolam
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 October 2020
- Identifiers
- RxCUI 2383946, 2383951DailyMed set ID 4e1838f2-b999-41a7-a761-d94f09aa531fNDC 71390-011Application NDA212295
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 |
|---|---|---|---|
| 10 vial in 1 carton / 8 mL in 1 vial | 71390-011-11 | Acacia Pharma | 6 October 2020 |
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
Remimazolam is a prescription medicine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. It is available as powder for injection for intravenous use. MedsAcross supplies Remimazolam 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 RemimazolamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BYFAVO prescribing information (Acacia Pharma) · U.S. National Library of Medicine, DailyMed
- Byfavo: European public assessment report (EPAR) · European Medicines Agency
Need Byfavo 2.5 mg/mL 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.