Medicine
Firdapse 10 mg tablet
Firdapse 10 mg tablet is a prescription medicine containing Amifampridine for oral use, marketed by Catalyst 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store FIRDAPSE tablets at 20°C to 25°C (68°F to 77°F) with excursions…
Key facts
- Active ingredient (INN)
- Amifampridine
- Brand
- Firdapse
- Strength
- 10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 240 tablets, 12 blister pack, 60 tablets
- Marketing authorisation holder
- Catalyst Pharmaceuticals
- Manufacturer
- Catalyst Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store FIRDAPSE tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F). See Dosage and Administration for storage instructions for FIRDAPSE prepared suspension.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX05 Amifampridine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 January 2019
- Identifiers
- RxCUI 2106343, 2107518DailyMed set ID f015fe60-3128-4a43-8c31-19fc6b5def3fNDC 69616-211Application NDA208078
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 |
|---|---|---|---|
| 240 tablet in 1 bottle, plastic | 69616-211-03 | Catalyst Pharmaceuticals | 7 January 2019 |
| 12 blister pack in 1 carton / 10 tablet in 1 blister pack | 69616-211-06 | Catalyst Pharmaceuticals | 7 January 2019 |
| 60 tablet in 1 bottle, plastic | 69616-211-08 | Catalyst Pharmaceuticals | 7 January 2019 |
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
Clinical summary
Amifampridine is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. It is available as tablets for oral use. MedsAcross supplies Amifampridine 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 AmifampridineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Firdapse prescribing information (Catalyst Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Firdapse (previously Zenas): European public assessment report (EPAR) · European Medicines Agency
- Amifampridine SERB: European public assessment report (EPAR) · European Medicines Agency
Need Firdapse 10 mg tablet 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.