Drug
Who makes dimethyl fumarate?
20 companies list dimethyl fumarate as a human prescription drug, including under the names Tecfidera. Forms: capsule; capsule, delayed release; kit. 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 dimethyl fumarate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Macleods Pharmaceuticals LimitedIndia | capsule, delayed release; kit | ANDAANDA210377 | 4 | 5 |
| Golden State Medical Supply Inc.United States | capsule, delayed release | ANDAANDA210382, ANDA210385 | 4 | 1 |
| MSN Laboratories Private Limited,India | capsule, delayed release; kit | ANDAANDA210460 | 3 | 8 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | capsule, delayed release; kit | ANDAANDA210305 | 3 | 7 |
| Biogen International GmbHUnited States | capsule; kit | NDANDA204063 | 3 | 3 |
| Camber Pharmaceuticals, Inc.United States | capsule, delayed release; kit | ANDAANDA210500 | 3 | 1 |
| ASCEND Therapeutics US, LLC | capsule, delayed release; kit | ANDAANDA210440 | 3 | 0 |
| Amneal Pharmaceuticals NY LLC | capsule, delayed release; kit | ANDAANDA210402 | 3 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | capsule, delayed release | ANDAANDA210460 | 2 | 15 |
| Zydus Lifesciences LimitedIndia | capsule, delayed release | ANDAANDA210538 | 2 | 12 |
| Glenmark Pharmaceuticals Inc., USAIndia | capsule | ANDAANDA210309 | 2 | 9 |
| Aurobindo Pharma LimitedIndia | capsule, delayed release | ANDAANDA210385 | 2 | 6 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | capsule, delayed release | ANDAANDA210499 | 2 | 2 |
| Zydus Pharmaceuticals USA Inc.India | capsule, delayed release | ANDAANDA210538 | 2 | 1 |
| CivicaScript, LLC | capsule, delayed release | ANDAANDA210440 | 2 | 0 |
| SOLA Pharmaceuticals, LLC | capsule, delayed release | ANDAANDA210436 | 2 | 0 |
| Solco healthcare U.S., LLC | capsule, delayed release | ANDAANDA210414 | 2 | 0 |
| Upsher-Smith Laboratories, Inc. | capsule, delayed release | ANDAANDA210382 | 2 | 0 |
| International Medication Systems, Ltd.United States | capsule, delayed release | ANDAANDA210500 | 1 | 3 |
| Quallent Pharmaceuticals Health, LLC | capsule, delayed release | ANDAANDA210500 | 1 | 0 |
Bulk ingredient listings
- Honour Lab LimitedIndia · 2 NDC
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 1 NDC
- Arevipharma GmbHGermany · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- DOTTIKON EXCLUSIVE SYNTHESIS AGSwitzerland · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Dr. Reddys Laboratories Limited · 1 NDC
- Granules Pharmaceuticals Inc.India · 1 NDC
- Laboratorium Ofichem BVNetherlands · 1 NDC
- MSN Organics Private LimitedIndia · 1 NDC
- Mylan Pharmaceuticals, Inc. · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Optimus Drugs Private LimitedIndia · 1 NDC
- SHILPA PHARMA LIFESCIENCES LIMITEDIndia · 1 NDC
- Sigma-Aldrich Production GmbH · 1 NDC
- Sionc Pharmaceuticals Private LimitedIndia · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Veranova, L.P.United States · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
Orange Book patents
9 unexpired patents list dimethyl fumarate as the active ingredient, expiring between Feb 2028 and Nov 2035. Application holder: BIOGEN INC.
Enquiry
Common questions
- Who makes dimethyl fumarate?
- 20 companies list dimethyl fumarate as a human prescription drug in the openFDA NDC Directory, led by Macleods Pharmaceuticals Limited, Golden State Medical Supply Inc., MSN Laboratories Private Limited,, CIPLA PHARMACEUTICALS LIMITED, Biogen International GmbH. 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 Tecfidera?
- 19 companies list dimethyl fumarate 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 dimethyl fumarate active ingredient?
- 20 companies list dimethyl fumarate as a bulk ingredient, including Honour Lab Limited, Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.), Arevipharma GmbH, Aurobindo Pharma Limited.