Medicine
Zynteglo 20000000 injectable suspension
Zynteglo 20000000 injectable suspension is a prescription medicine containing Betibeglogene autotemcel for intravenous use, marketed by Genetix Biotherapeutics, 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
Do not re-freeze after thawing. Keep the infusion bag(s) in the metal…
Key facts
- Active ingredient (INN)
- Betibeglogene autotemcel
- Brand
- Zynteglo
- Strength
- 20000000
- Dosage form
- Injectable suspension
- Route
- Intravenous
- Packs
- 1 suspension
- Marketing authorisation holder
- Genetix Biotherapeutics
- Manufacturer
- Genetix Biotherapeutics
- Origin register
- US FDA, United States
- Storage
- Do not re-freeze after thawing. Keep the infusion bag(s) in the metal cassette(s) and store in the vapor phase of liquid nitrogen at less than or equal to -140°C (≤ -220°F) until ready for thaw and administration.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B06AX02 Betibeglogene autotemcel
- HS code (indicative)
- 3002.51Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 August 2022
- Identifiers
- RxCUI 2610435, 2610436DailyMed set ID 86931613-c262-47f5-8202-bc31fa69ad3dNDC 73554-3111Application BLA125717
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 suspension in 1 bag | 73554-3111-1 | Genetix Biotherapeutics | 17 August 2022 |
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
Betibeglogene autotemcel is a prescription medicine indicated for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions. It is available as injectable suspension for intravenous use. MedsAcross supplies Betibeglogene autotemcel 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 Betibeglogene autotemcelFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zynteglo prescribing information (Genetix Biotherapeutics) · U.S. National Library of Medicine, DailyMed
Need Zynteglo 20000000 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.