Medicine
Voyxact 400 mg/2 mL injection
Voyxact 400 mg/2 mL injection is a prescription medicine containing Sibeprenlimab for subcutaneous use, marketed by Otsuka America 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 VOYXACT in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze…
Key facts
- Active ingredient (INN)
- Sibeprenlimab
- Brand
- Voyxact
- Strength
- 400 mg/2 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 2 mL
- Marketing authorisation holder
- Otsuka America Pharmaceutical
- Manufacturer
- Otsuka America Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store VOYXACT in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Once VOYXACT prefilled syringe has reached room temperature, do not return it to the refrigerator. Do not use VOYXACT if it has been at room temperature for 7 days or longer. Do not shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 November 2025
- Identifiers
- RxCUI 2728400, 2728407DailyMed set ID c8a93b32-0676-4704-86dc-cb65f425c6e5NDC 59148-400Application BLA761434
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 in 1 carton / 2 mL in 1 syringe | 59148-400-75 | Otsuka America Pharmaceutical | 25 November 2025 |
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 |
| US FDA | First approved 25 November 2025 | Drugs@FDA |
| 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
Sibeprenlimab is a prescription medicine indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. It is available as injection for subcutaneous use. MedsAcross supplies Sibeprenlimab 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 SibeprenlimabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VOYXACT prescribing information (Otsuka America Pharmaceutical) · U.S. National Library of Medicine, DailyMed
Need Voyxact 400 mg/2 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.