Ryoncil kit is a prescription medicine containing Remestemcel-l, marketed by Mesoblast, 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
conditions: RYONCIL must remain frozen at ≤ -135°C in liquid nitrogen vapor…
Key facts
- Active ingredient (INN)
- Remestemcel-l
- Brand
- Ryoncil
- Dosage form
- Kit
- Packs
- 1 kit and 9 more
- Marketing authorisation holder
- Mesoblast
- Manufacturer
- Mesoblast
- Origin register
- US FDA, United States
- Storage
- conditions: RYONCIL must remain frozen at ≤ -135°C in liquid nitrogen vapor phase until thawed immediately prior to administration.
- 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
- 17 March 2025
- Identifiers
- RxCUI 797544, 2700771, 2700778 +7DailyMed set ID a4e0918f-7444-4694-adeb-d38d98345659NDC 73648-116, 73648-121, 73648-113 +9Application BLA125706
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 kit in 1 carton * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch | 73648-111-01 | Mesoblast | 17 March 2025 |
| 1 kit in 1 carton * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-112-02 | Mesoblast | 17 March 2025 |
| 1 kit in 1 carton * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-113-03 | Mesoblast | 17 March 2025 |
| 1 kit in 1 carton * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch | 73648-114-01 | Mesoblast | 17 March 2025 |
| 1 kit in 1 carton * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-115-02 | Mesoblast | 17 March 2025 |
| 1 kit in 1 carton * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-116-03 | Mesoblast | 17 March 2025 |
| 1 kit in 1 carton * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-117-04 | Mesoblast | 17 March 2025 |
| 1 kit in 1 carton * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-118-02 | Mesoblast | 17 March 2025 |
| 1 kit in 1 carton * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-119-03 | Mesoblast | 28 September 2025 |
| 1 kit in 1 carton * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-120-04 | Mesoblast | 28 September 2025 |
| 1 kit in 1 carton * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 1 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-121-05 | Mesoblast | 28 September 2025 |
| 1 kit in 1 carton * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic * 1 mL in 1 pouch * 4 vial, plastic in 1 carton / 3.8 mL in 1 vial, plastic | 73648-122-03 | Mesoblast | 28 September 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 |
| 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
Remestemcel-l is a prescription medicine indicated for the treatment of steroid refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. It is available as kits. MedsAcross supplies Remestemcel-l 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 Remestemcel-lFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RYONCIL prescribing information (Mesoblast) · U.S. National Library of Medicine, DailyMed
Need Ryoncil kit 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.