Medicine
Xospata 40 mg tablet
Xospata 40 mg tablet is a prescription medicine containing Gilteritinib for oral use, marketed by Astellas 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 XOSPATA tablets at 20ºC to 25ºC (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Gilteritinib
- Brand
- Xospata
- Strength
- 40 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Astellas Pharma
- Manufacturer
- Astellas Pharma
- Origin register
- US FDA, United States
- Storage
- Store XOSPATA tablets at 20ºC to 25ºC (68°F to 77°F), excursions permitted between 15ºC to 30ºC (59°F to 86°F). Protect from light, moisture and humidity.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EX13 Gilteritinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 November 2018
- Identifiers
- RxCUI 2105811, 2105817DailyMed set ID b5ff59aa-9c0d-49a8-9053-1f179b482383NDC 0469-1425Application NDA211349
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 bottle in 1 carton / 21 tablet in 1 bottle | 0469-1425-70 | Astellas Pharma | 2 November 2026 |
| 1 bottle in 1 carton / 90 tablet in 1 bottle | 0469-1425-90 | Astellas Pharma | 29 November 2018 |
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
Gilteritinib is a prescription medicine indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. MedsAcross supplies Gilteritinib 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 GilteritinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xospata prescribing information (Astellas Pharma) · U.S. National Library of Medicine, DailyMed
- Xospata: European public assessment report (EPAR) · European Medicines Agency
Need Xospata 40 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.