Medicine
Vigafyde 100 mg/mL oral solution
Vigafyde 100 mg/mL oral solution is a prescription medicine containing Vigabatrin for oral use, marketed by Upsher-Smith Laboratories, 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 unopened bottles at room temperature between 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Vigabatrin
- Brand
- Vigafyde
- Strength
- 100 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Upsher-Smith Laboratories
- Manufacturer
- Upsher-Smith Laboratories
- Origin register
- US FDA, United States
- Storage
- Store unopened bottles at room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). After opening, store bottle in a refrigerator or at room temperature between 2°C to 30°C (36°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AG04 Vigabatrin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 June 2024
- Identifiers
- RxCUI 2685217, 2685223DailyMed set ID 8d3d6316-33ab-41e8-9485-4495c218be56NDC 80789-003Application NDA217684
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 bottle in 1 carton / 150 mL in 1 bottle | 80789-003-15 | Upsher-Smith Laboratories | 26 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
Other strengths and forms of Vigabatrin
Clinical summary
Vigabatrin is an anti-epileptic agent indicated for the treatment of refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments, among other approved uses. MedsAcross supplies Vigabatrin 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 VigabatrinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SABRIL prescribing information (Lundbeck Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Kigabeq: European public assessment report (EPAR) · European Medicines Agency
Need Vigafyde 100 mg/mL oral solution 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.