Medicine
Aqneursa 1000 mg oral suspension
Aqneursa 1000 mg oral suspension is a prescription medicine containing Levacetylleucine for oral use, marketed by IntraBio, 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 AQNEURSA at room temperature between 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Levacetylleucine
- Brand
- Aqneursa
- Strength
- 1000 mg
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 28 packets
- Marketing authorisation holder
- IntraBio
- Manufacturer
- IntraBio
- Origin register
- US FDA, United States
- Storage
- Store AQNEURSA at room temperature between 20°C to 25°C (68°F to 77°F), excursion permitted between 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 September 2024
- Identifiers
- RxCUI 2693617, 2693623DailyMed set ID 0f248e55-d1bb-13f9-e063-6294a90a05ceNDC 83853-101Application NDA219132
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 |
|---|---|---|---|
| 28 packet in 1 carton / 1 granule, for suspension in 1 packet | 83853-101-01 | IntraBio | 24 September 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 |
| US FDA | First approved 24 September 2024 | Drugs@FDA |
| 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
Levacetylleucine is a prescription medicine indicated for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg, among other approved uses. It is available as oral suspension. MedsAcross supplies Levacetylleucine 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 LevacetylleucineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- AQNEURSA prescribing information (IntraBio) · U.S. National Library of Medicine, DailyMed
Need Aqneursa 1000 mg oral 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.