Drug
Who makes difluprednate?
6 companies list difluprednate as a human prescription drug, including under the names DUREZOL. Forms: emulsion. 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 difluprednate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| CIPLA PHARMACEUTICALS LIMITEDIndia | emulsion | ANDAANDA211776 | 1 | 7 |
| Sandoz Industrial Products S.AAustria | emulsion | NDANDA022212 | 1 | 5 |
| CAPLIN STERILES LIMITEDIndia | emulsion | ANDAANDA219441 | 1 | 1 |
| Leading Pharma, LLCUnited States | emulsion | ANDAANDA219441 | 1 | 1 |
| Mylan Pharmaceuticals, Inc. | emulsion | ANDAANDA212566 | 1 | 0 |
| Upsher-Smith Laboratories, Inc. | emulsion | ANDAANDA218191 | 1 | 0 |
Bulk ingredient listings
- Farmabios S.p.A.Italy · 2 NDC
- Steroid S.p.A.Italy · 1 NDC
- Tianjin Pacific Chemical & Pharmaceutical Co., Ltd.China · 1 NDC
Enquiry
Common questions
- Who makes difluprednate?
- 6 companies list difluprednate as a human prescription drug in the openFDA NDC Directory, led by CIPLA PHARMACEUTICALS LIMITED, Sandoz Industrial Products S.A, CAPLIN STERILES LIMITED, Leading Pharma, LLC, Mylan Pharmaceuticals, 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 DUREZOL?
- 5 companies list difluprednate 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 difluprednate active ingredient?
- 3 companies list difluprednate as a bulk ingredient, including Farmabios S.p.A., Steroid S.p.A., Tianjin Pacific Chemical & Pharmaceutical Co., Ltd..