Medicine
Vyloy 20 mg/mL powder for injectable suspension
Vyloy 20 mg/mL powder for injectable suspension is a prescription medicine containing Zolbetuximab for intravenous 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
Storage as on the product label
Key facts
- Active ingredient (INN)
- Zolbetuximab
- Brand
- Vyloy
- Strength
- 20 mg/mL
- Dosage form
- Powder for injectable suspension
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Astellas Pharma
- Manufacturer
- Astellas Pharma
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FX31 Zolbetuximab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 October 2024
- Identifiers
- RxCUI 2695876, 2695882, 2710430 +1DailyMed set ID e7695a21-abb6-47ac-93f8-0ece5a9c4409NDC 0469-3425, 0469-4425Application BLA761365
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 vial in 1 box / 5 mL in 1 vial | 0469-3425-10 | Astellas Pharma | 24 October 2024 |
| 1 vial in 1 box / 15 mL in 1 vial | 0469-4425-30 | Astellas Pharma | 24 April 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.
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
Zolbetuximab is a claudin 18.2-directed cytolytic antibody indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, among other approved uses. MedsAcross supplies Zolbetuximab 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 ZolbetuximabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VYLOY prescribing information (Astellas Pharma) · U.S. National Library of Medicine, DailyMed
- Vyloy: European public assessment report (EPAR) · European Medicines Agency
Need Vyloy 20 mg/mL powder for injectable suspension 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.