Medicine
Lantidra 5000 units/400 mL injection
Lantidra 5000 units/400 mL injection is a prescription medicine containing Donislecel for intravascular use, marketed by CellTrans, 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 in the insulated container at 15°C to 25°C for up to 48 hours from time…
Key facts
- Active ingredient (INN)
- Donislecel
- Brand
- Lantidra
- Strength
- 5000 units/400 mL
- Dosage form
- Injection
- Route
- Intravascular
- Packs
- 400 mL
- Marketing authorisation holder
- CellTrans
- Manufacturer
- CellTrans
- Origin register
- US FDA, United States
- Storage
- Store in the insulated container at 15°C to 25°C for up to 48 hours from time of product release.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.51Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 June 2023
- Identifiers
- RxCUI 2642264, 2642270DailyMed set ID 24610d9f-0c5a-4f55-93b3-d456300bfd5dNDC 73539-001Application BLA125734
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 |
|---|---|---|---|
| 400 mL in 1 bag | 73539-001-01 | CellTrans | 28 June 2023 |
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
Donislecel is a prescription medicine indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. MedsAcross supplies Donislecel 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 DonislecelFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LANTIDRA prescribing information (CellTrans) · U.S. National Library of Medicine, DailyMed
Need Lantidra 5000 units/400 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.