Medicine
Tregzi kit
Tregzi kit is a prescription medicine containing Allogeneic regulatory t cell immunotherapy with hspc and T cells, marketed by Orca Biosystems, 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
Store the Tregs and HSPCs in refrigerated storage at 2°C to 8°C (36°F to 46°F)…
Key facts
- Active ingredient (INN)
- Allogeneic regulatory t cell immunotherapy with hspc and T cells
- Brand
- Tregzi
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Orca Biosystems
- Manufacturer
- Orca Biosystems
- Origin register
- US FDA, United States
- Storage
- Store the Tregs and HSPCs in refrigerated storage at 2°C to 8°C (36°F to 46°F) until the time of use. Per institutional guidelines, Tregs and HSPCs may be kept in shipping container or moved to refrigerated storage up to the expiry time. Do not freeze. Cryopreserved TREGZI Tcons The Tcons are shipped frozen in vapor phase of liquid nitrogen at below -125°C (below -193°F).
- Cold chain
- Yes, shipped temperature controlled
- 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
- 30 June 2026
- Identifiers
- RxCUI 2747373, 2747379DailyMed set ID 2157e11b-87c3-4d54-a225-81b341e4e21aNDC 85866-223Application BLA125868
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 * 100 mL in 1 bag * 1 bag in 1 cartridge / 15 mL in 1 bag * 1 bag in 1 carton / 30 mL in 1 bag * 100 mL in 1 bag | 85866-223-04 | Orca Biosystems | 30 June 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 |
| 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
Allogeneic regulatory t cell immunotherapy with hspc and T cells is a fixed-dose combination medicine. It is available as kits. MedsAcross supplies Allogeneic regulatory t cell immunotherapy with hspc and T cells 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 Allogeneic regulatory t cell immunotherapy with hspc and T cellsFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TREGZI prescribing information (Orca Biosystems) · U.S. National Library of Medicine, DailyMed
Need Tregzi 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.