Drug
Who makes dalfampridine?
10 companies list dalfampridine as a human prescription drug, including under the names AMPYRA. Forms: tablet, extended release; tablet, film coated, extended release. 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 dalfampridine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Merz Pharma GmbH & Co. KGaAGermany | tablet, film coated, extended release | NDANDA022250 | 2 | 3 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, extended release | ANDAANDA208292 | 1 | 13 |
| Aurobindo Pharma LimitedIndia | tablet, film coated, extended release | ANDAANDA206811 | 1 | 6 |
| Micro Labs LimitedIndia | tablet, extended release | ANDAANDA210158 | 1 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated, extended release | ANDAANDA206863 | 1 | 2 |
| Actavis LLCUnited States | tablet, film coated, extended release | ANDAANDA206836 | 1 | 1 |
| Bryant Ranch PrepackUnited States | tablet, extended release | ANDAANDA210158 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet, film coated, extended release | ANDAANDA206765 | 1 | 1 |
| ASCEND Therapeutics US, LLC | tablet, film coated, extended release | ANDAANDA206765 | 1 | 0 |
| CivicaScript, LLC | tablet, film coated, extended release | ANDAANDA206765 | 1 | 0 |
Bulk ingredient listings
- Industriale Chimica SRLItaly · 2 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Esteve CDMO US, Inc. dba Regis Chemical CompanyUnited States · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- PROCOS SpAItaly · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes dalfampridine?
- 10 companies list dalfampridine as a human prescription drug in the openFDA NDC Directory, led by Merz Pharma GmbH & Co. KGaA, Sun Pharmaceutical Industries Limited, Aurobindo Pharma Limited, Micro Labs Limited, ACCORD HEALTHCARE LIMITED. 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 AMPYRA?
- 9 companies list dalfampridine under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies dalfampridine active ingredient?
- 8 companies list dalfampridine as a bulk ingredient, including Industriale Chimica SRL, Aurobindo Pharma Limited, Esteve CDMO US, Inc. dba Regis Chemical Company, Jubilant Biosys Limited.