Medicine
Impavido 50 mg capsule
Impavido 50 mg capsule is a prescription medicine containing Miltefosine for oral use, marketed by Eton 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 at 20-25 °C (68-77 °F), excursions permitted to 15-30 °C (59-86 °F)…
Key facts
- Active ingredient (INN)
- Miltefosine
- Brand
- Impavido
- Strength
- 50 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 2 blister pack
- Marketing authorisation holder
- Eton Pharmaceuticals
- Manufacturers
- Eton PharmaceuticalsProfounda
- Origin register
- US FDA, United States
- Storage
- Store at 20-25 °C (68-77 °F), excursions permitted to 15-30 °C (59-86 °F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XX09 Miltefosine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 October 2015
- Identifiers
- RxCUI 1494071, 1495070DailyMed set ID bcb387ac-2e90-4f5e-94b2-d3635190678e, 57c515c8-f4af-b876-e063-6394a90af0ccNDC 69051-300, 71863-135Application NDA204684
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 |
|---|---|---|---|
| 2 blister pack in 1 carton / 14 capsule in 1 blister pack | 71863-135-28 | Eton Pharmaceuticals | 26 September 2026 |
| 2 blister pack in 1 carton / 14 capsule in 1 blister pack | 69051-300-01 | Profounda | 29 October 2015 |
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 19 March 2014 | 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
Miltefosine is an antileishmanial indicated in adults and pediatric patients 12 years of age and older weighing greater than or equal to 30 kg (66 lbs) for the treatment of visceral leishmaniasis caused by Leishmania donovani. MedsAcross supplies Miltefosine 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 MiltefosineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- IMPAVIDO prescribing information (Eton Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Impavido 50 mg capsule 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.