Medicine
Opfolda 65 mg capsule
Opfolda 65 mg capsule is a prescription medicine containing Miglustat 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 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Miglustat
- Brand
- Opfolda
- Strength
- 65 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 4 bottles, 24 bottles, 100 bottles
- Marketing authorisation holder
- Amicus Therapeutics
- Manufacturer
- Amicus Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F),. Store in the original container to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AX06 Miglustat
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 October 2023
- Identifiers
- RxCUI 2667426, 2667432DailyMed set ID d7c38298-37db-5a80-e053-2995a90aee40NDC 71904-300Application NDA215211
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 |
|---|---|---|---|
| 4 bottle, plastic in 1 bottle, plastic / 1 capsule in 1 bottle, plastic | 71904-300-01 | Amicus Therapeutics | 11 October 2023 |
| 24 bottle, plastic in 1 bottle, plastic / 1 capsule in 1 bottle, plastic | 71904-300-02 | Amicus Therapeutics | 11 October 2023 |
| 100 bottle, plastic in 1 bottle, plastic / 1 capsule in 1 bottle, plastic | 71904-300-03 | Amicus Therapeutics | 11 October 2023 |
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 Miglustat
Clinical summary
Miglustat is a glucosylceramide synthase inhibitor indicated as monotherapy for treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option. MedsAcross supplies Miglustat 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 MiglustatFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Miglustat prescribing information (CoTherix) · U.S. National Library of Medicine, DailyMed
- Opfolda: European public assessment report (EPAR) · European Medicines Agency
- Zavesca: European public assessment report (EPAR) · European Medicines Agency
Need Opfolda 65 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.