Drug
Who makes bromfenac sodium?
6 companies list bromfenac sodium as a human prescription drug, including under the names Prolensa. Forms: solution/ drops. Routes: ophthalmic.
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 bromfenac sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Alembic Pharmaceuticals LimitedIndia | solution/ drops | ANDAANDA214340 | 2 | 7 |
| Dr. Reddy's Laboratories LimitedIndia | solution/ drops | NDA AUTHORIZED GENERICNDA203168 | 1 | 15 |
| Lupin LimitedIndia | solution/ drops | ANDAANDA206027 | 1 | 14 |
| Apotex Inc.Canada | solution/ drops | ANDAANDA207334 | 1 | 6 |
| Bausch & Lomb Ireland LimitedUnited States | solution/ drops | NDANDA203168 | 1 | 4 |
| Bausch & Lomb Americas Inc. | solution/ drops | NDA AUTHORIZED GENERICNDA203168 | 1 | 0 |
Bulk ingredient listings
- Apicore US LLCIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Esteve CDMO US, Inc. dba Regis Chemical CompanyUnited States · 1 NDC
- Indoco Remedies LimitedIndia · 1 NDC
Orange Book patents
3 unexpired patents list bromfenac sodium as the active ingredient, expiring between Mar 2029 and Nov 2033. Application holders: BAUSCH AND LOMB INC, SUN PHARMACEUTICAL INDUSTRIES LTD.
Enquiry
Common questions
- Who makes bromfenac sodium?
- 6 companies list bromfenac sodium as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Dr. Reddy's Laboratories Limited, Lupin Limited, Apotex Inc., Bausch & Lomb Ireland 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 Prolensa?
- 3 companies list bromfenac sodium 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 bromfenac sodium active ingredient?
- 4 companies list bromfenac sodium as a bulk ingredient, including Apicore US LLC, Darmerica, LLC, Esteve CDMO US, Inc. dba Regis Chemical Company, Indoco Remedies Limited.