Drug
Who makes edaravone?
5 companies list edaravone as a human prescription drug, including under the names RADICAVA ORS. Forms: injection; injection, solution; kit. Routes: intravenous.
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 edaravone
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| GLAND PHARMA LIMITEDIndia | injection, solution | ANDAANDA216199 | 2 | 4 |
| Shionogi Pharma Co., Ltd.Japan | kit | NDANDA215446 | 2 | 4 |
| Sandoz Industrial Products S.AAustria | injection | ANDAANDA216902 | 1 | 5 |
| Piramal Critical Care IncUnited States | injection, solution | ANDAANDA216199 | 1 | 1 |
| XGen Pharmaceuticals DJB, Inc. | injection, solution | ANDAANDA217565 | 1 | 0 |
Bulk ingredient listings
- Biophore India Pharmaceuticals Private LimitedIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Dr. Reddys Laboratories Limited · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- Interquim, S.A.Spain · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Medichem Manufacturing (Malta) Ltd. · 1 NDC
- Medichem SASpain · 1 NDC
- Neuland Laboratories LimitedIndia · 1 NDC
- QUIMICA SINTETICA SASpain · 1 NDC
- SOLARA ACTIVE PHARMA SCIENCES LIMITEDIndia · 1 NDC
- Shionogi Pharma Co., Ltd.Japan · 1 NDC
- YUNG ZIP CHEMICAL IND. CO., LTD.Taiwan · 1 NDC
Orange Book patents
12 unexpired patents list edaravone as the active ingredient, expiring between Nov 2039 and Nov 2041. Application holder: SHIONOGI INC.
Enquiry
Common questions
- Who makes edaravone?
- 5 companies list edaravone as a human prescription drug in the openFDA NDC Directory, led by GLAND PHARMA LIMITED, Shionogi Pharma Co., Ltd., Sandoz Industrial Products S.A, Piramal Critical Care Inc, XGen Pharmaceuticals DJB, Inc.. 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 RADICAVA ORS?
- 4 companies list edaravone 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 edaravone active ingredient?
- 13 companies list edaravone as a bulk ingredient, including Biophore India Pharmaceuticals Private Limited, CIPLA PHARMACEUTICALS LIMITED, Dr. Reddys Laboratories Limited, Honour Lab Limited.