Medicine
Rufinamide 40 mg/mL oral suspension
Rufinamide 40 mg/mL oral suspension is a generic prescription medicine for oral use, made by 9 labelers, 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 the oral suspension at 20º to 25ºC (68º to 77ºF). Store the oral…
Key facts
- Active ingredient (INN)
- Rufinamide
- Brand
- Sold under the generic name
- Strength
- 40 mg/mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 1 bottle, 3 trays and 6 more
- Manufacturers
- Ascend LaboratoriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaLupinIndiaNovadoz PharmaceuticalsIndiaAmerican Health PackagingBionpharmaHikma PharmaceuticalsNorthStar RxLLC
- Origin register
- US FDA, United States
- Storage
- Store the oral suspension at 20º to 25ºC (68º to 77ºF). Store the oral suspension in an upright position.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AF03 Rufinamide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 December 2018
- Identifiers
- RxCUI 1092357DailyMed set ID 1c2f9bf2-1711-4975-af02-32614db25add, 1e671632-d5bd-499a-ba06-0d1dc0d99622, 1a0b80de-754d-4e60-b5a9-b6daa323bf58 +6NDC 31722-688, 68180-797, 60687-824 +6Application ANDA216841, ANDA213457, ANDA207363 +4
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 460 mL in 1 bottle | 67877-673-62 | Ascend LaboratoriesIndia | 24 February 2021 |
| 1 bottle in 1 carton / 460 mL in 1 bottle | 59651-563-60 | Aurobindo PharmaIndia | 26 October 2022 |
| 1 bottle in 1 carton / 460 mL in 1 bottle | 31722-688-46 | Camber PharmaceuticalsIndia | 5 December 2023 |
| 1 bottle in 1 carton / 460 mL in 1 bottle | 68180-797-01 | LupinIndia | 22 June 2023 |
| 1 bottle in 1 carton / 460 mL in 1 bottle | 72205-038-77 | Novadoz PharmaceuticalsIndia | 1 June 2025 |
| 1 bottle in 1 carton / 460 mL in 1 bottle | 69452-223-84 | Bionpharma | 6 November 2020 |
| 1 bottle in 1 carton / 460 mL in 1 bottle | 0054-0528-63 | Hikma Pharmaceuticals | 1 November 2020 |
| 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 60687-824-08 | American Health Packaging | 6 January 2026 |
| 1 bottle in 1 carton / 460 mL in 1 bottle | 72603-261-01 | NorthStar RxLLC | 1 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.
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
Alternatives
Other makers and brands of Rufinamide 40 mg/mL oral suspension.
Other strengths and forms of Rufinamide
Clinical summary
Rufinamide is a prescription medicine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. It is available as tablets and oral suspension. MedsAcross supplies Rufinamide 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 RufinamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Banzel prescribing information (Eisai) · U.S. National Library of Medicine, DailyMed
- Inovelon: European public assessment report (EPAR) · European Medicines Agency
Need Rufinamide 40 mg/mL oral suspension for your hospital or patient?
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