Medicine
Miplyffa 124 mg capsule
Miplyffa 124 mg capsule is a prescription medicine containing Arimoclomol for oral use, marketed by Acer Therapeutics, 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 MIPLYFFA at 20°C to 25°C (68°F to 77°F), excursions permitted between…
Key facts
- Active ingredient (INN)
- Arimoclomol
- Brand
- Miplyffa
- Strength
- 124 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Acer Therapeutics
- Manufacturer
- Acer Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store MIPLYFFA at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Store in original container. Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX17 Arimoclomol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 September 2024
- Identifiers
- RxCUI 2694288, 2694294, 2694296 +5DailyMed set ID 5feffc0e-453d-47fa-91dd-38d4952309bcNDC 72542-124Application NDA214927
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 / 90 capsule in 1 bottle | 72542-124-01 | Acer Therapeutics | 20 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 20 September 2024 | Drugs@FDA |
| EU (EMA) | Opinion | EMA medicines data |
| 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
Other strengths and forms of Arimoclomol
Clinical summary
Arimoclomol is a prescription medicine indicated in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. MedsAcross supplies Arimoclomol 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 ArimoclomolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- MIPLYFFA prescribing information (Acer Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Miplyffa 124 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.