Medicine
Otarmeni 30000000000000 GC/mL injection
Otarmeni 30000000000000 GC/mL injection is a prescription medicine containing Lunsotogene parvec for intracochlear use, marketed by Regeneron Pharmaceuticals, 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
If not used immediately, the unpunctured thawed vial can be stored in the…
Key facts
- Active ingredient (INN)
- Lunsotogene parvec
- Brand
- Otarmeni
- Strength
- 30000000000000 GC/mL
- Dosage form
- Injection
- Route
- Intracochlear
- Packs
- 1 carton
- Marketing authorisation holder
- Regeneron Pharmaceuticals
- Manufacturer
- Regeneron Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- If not used immediately, the unpunctured thawed vial can be stored in the refrigerator (2°C to 8°C [36°F to 46°F]) for up to 24 hours or at room temperature (up to 25°C [77°F]) for up to 8 hours. Store and transport OTARMENI (package 1) frozen at -80°C (-112°F). Thaw OTARMENI at room temperature prior to administration.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 April 2026
- Identifiers
- RxCUI 2741622, 2741629DailyMed set ID a7a5e936-ab4a-4609-ac10-96efedc89035NDC 61755-062Application BLA125874
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 carton in 1 bag / 1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 61755-062-99 | Regeneron Pharmaceuticals | 23 April 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
Lunsotogene parvec is a prescription medicine. It is available as injection for intracochlear use. MedsAcross supplies Lunsotogene parvec 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 Lunsotogene parvecFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- OTARMENI prescribing information (Regeneron Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Otarmeni 30000000000000 GC/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.