Medicine
Galafold 123 mg capsule
Galafold 123 mg capsule is a prescription medicine containing Migalastat for oral use, marketed by Amicus 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 at USP Controlled Room Temperature of 20° to 25°C (68° to 77°F)…
Key facts
- Active ingredient (INN)
- Migalastat
- Brand
- Galafold
- Strength
- 123 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 14 blister pack
- Marketing authorisation holder
- Amicus Therapeutics
- Manufacturer
- Amicus Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at USP Controlled Room Temperature of 20° to 25°C (68° to 77°F). Excursions are permitted between 15° to 30°C (59° to 86°F). Store in the original packaging to protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AX14 Migalastat
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 August 2018
- Identifiers
- RxCUI 2054257, 2054263, 2054266 +1DailyMed set ID 66dbd928-0f1c-48b1-a832-54e4abd9f1dbNDC 71904-100Application NDA208623
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 |
|---|---|---|---|
| 14 blister pack in 1 carton / 1 capsule in 1 blister pack | 71904-100-01 | Amicus Therapeutics | 10 August 2018 |
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
Migalastat is a prescription medicine indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene ( GLA ) variant based on in vitro assay data. MedsAcross supplies Migalastat 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 MigalastatFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Galafold prescribing information (Amicus Therapeutics) · U.S. National Library of Medicine, DailyMed
- Galafold: European public assessment report (EPAR) · European Medicines Agency
Need Galafold 123 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.