Medicine
Bysanti 4 mg tablet
Bysanti 4 mg tablet is a prescription medicine containing Milsaperidone for oral use, marketed by Vanda Pharmaceuticals, 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 the tablets at controlled room temperature, 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Milsaperidone
- Brand
- Bysanti
- Strength
- 4 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 60 tablets
- Marketing authorisation holder
- Vanda Pharmaceuticals
- Manufacturer
- Vanda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store the tablets at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15° to 30 °C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 July 2026
- Identifiers
- RxCUI 2745770, 2745776, 2745778 +7DailyMed set ID 254a1c01-4a4c-4bdd-85d6-1f23f2e4e6f8NDC 43068-704Application NDA220358
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 |
|---|---|---|---|
| 60 tablet in 1 bottle | 43068-704-02 | Vanda Pharmaceuticals | 1 July 2026 |
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 20 February 2026 | 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
Other strengths and forms of Milsaperidone
Clinical summary
Milsaperidone is a prescription medicine indicated for the treatment of schizophrenia in adults. It is available as tablets and kits for oral use. MedsAcross supplies Milsaperidone 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 MilsaperidoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BYSANTI prescribing information (Vanda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Bysanti 4 mg tablet 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.