Drug
Who makes miglustat?
7 companies list miglustat as a human prescription drug, including under the names OPFOLDA, Zavesca, Yargesa. Forms: capsule. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing miglustat
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| ANI Pharmaceuticals, Inc.United States | capsule | ANDAANDA208342 | 1 | 1 |
| Navinta LLCUnited States | capsule | ANDAANDA219111 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule | ANDAANDA219111 | 1 | 1 |
| Actelion Pharmaceuticals US, Inc. | capsule | NDANDA021348 | 1 | 0 |
| Amicus Therapeutics US, LLC | capsule | NDANDA215211 | 1 | 0 |
| CoTherix, Inc. | capsule | NDA AUTHORIZED GENERICNDA021348 | 1 | 0 |
| Edenbridge Pharmaceuticals LLC. | capsule | ANDAANDA209821 | 1 | 0 |
Bulk ingredient listings
- APOTHECON PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- Amino Chemicals Ltd.Malta · 1 NDC
- Apicore US LLCIndia · 1 NDC
- Dipharma Francis SrlItaly · 1 NDC
- Lonza Biologics IncUnited States · 1 NDC
- Veranova, L.P.United States · 1 NDC
Orange Book patents
10 unexpired patents list miglustat as the active ingredient, expiring between Mar 2033 and Sept 2038. Application holder: AMICUS THERAPEUTICS US LLC.
Enquiry
Common questions
- Who makes miglustat?
- 7 companies list miglustat as a human prescription drug in the openFDA NDC Directory, led by ANI Pharmaceuticals, Inc., Navinta LLC, Zydus Pharmaceuticals USA Inc., Actelion Pharmaceuticals US, Inc., Amicus Therapeutics US, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic OPFOLDA?
- 4 companies list miglustat under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies miglustat active ingredient?
- 6 companies list miglustat as a bulk ingredient, including APOTHECON PHARMACEUTICALS PRIVATE LIMITED, Amino Chemicals Ltd., Apicore US LLC, Dipharma Francis Srl.