Medicine
Tecelra 10000000000 injectable suspension
Tecelra 10000000000 injectable suspension is a prescription medicine containing Afamitresgene autoleucel for intravenous use, marketed by Uswm CT, 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 TECELRA in the original packaging, containing the cassette(s) protecting…
Key facts
- Active ingredient (INN)
- Afamitresgene autoleucel
- Brand
- Tecelra
- Strength
- 10000000000
- Dosage form
- Injectable suspension
- Route
- Intravenous
- Packs
- 1 injection
- Marketing authorisation holder
- Uswm CT
- Manufacturer
- Uswm CT
- Origin register
- US FDA, United States
- Storage
- Store TECELRA in the original packaging, containing the cassette(s) protecting the infusion bag(s), in the vapor phase of liquid nitrogen at less than or equal to -130°C.
- 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
- 2 August 2024
- Identifiers
- RxCUI 2690269, 2690275DailyMed set ID ab24631f-3364-46e1-8074-7244863bcbabNDC 83205-0001Application BLA125789
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 injection, suspension in 1 bag | 83205-0001-2 | Uswm CT | 2 August 2024 |
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
Afamitresgene autoleucel is a prescription medicine indicated for the treatment of adults and pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P. MedsAcross supplies Afamitresgene autoleucel 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 Afamitresgene autoleucelFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TECELRA prescribing information (Uswm CT) · U.S. National Library of Medicine, DailyMed
Need Tecelra 10000000000 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.