Medicine
Lyfgenia 20000000/20 mL injectable suspension
Lyfgenia 20000000/20 mL injectable suspension is a prescription medicine containing Lovotibeglogene 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)
- Lovotibeglogene autotemcel
- Brand
- Lyfgenia
- Strength
- 20000000/20 mL
- Dosage form
- Injectable suspension
- Route
- Intravenous
- Packs
- 1 mL
- 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
- HS code (indicative)
- 3002.51Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 December 2023
- Identifiers
- RxCUI 2672691, 2672697DailyMed set ID 0d1b475e-5781-2bd1-e063-6294a90a7311NDC 73554-1111Application BLA125788
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 mL in 1 bag | 73554-1111-1 | Genetix Biotherapeutics | 8 December 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
Lovotibeglogene autotemcel is a prescription medicine indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events. MedsAcross supplies Lovotibeglogene 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 Lovotibeglogene 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
- Lyfgenia prescribing information (Genetix Biotherapeutics) · U.S. National Library of Medicine, DailyMed
Need Lyfgenia 20000000/20 mL 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.