Drug
Who makes prednisolone acetate?
10 companies list prednisolone acetate as a human prescription drug, including under the names PRED FORTE, PRED MILD. Forms: suspension/ 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 prednisolone acetate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | suspension/ drops | ANDA, NDA AUTHORIZED GENERICANDA216935, NDA017011, NDA017469 | 4 | 3 |
| Amneal Pharmaceuticals NY LLC | suspension/ drops | ANDAANDA218256 | 3 | 0 |
| Allergan, Inc.United States | suspension/ drops | NDANDA017011, NDA017100 | 2 | 7 |
| Sportpharm LLC | suspension/ drops | NDA AUTHORIZED GENERICNDA017011, NDA017469 | 2 | 0 |
| Lupin LimitedIndia | suspension/ drops | ANDAANDA216935 | 1 | 14 |
| Sandoz Industrial Products S.AAustria | suspension/ drops | NDA AUTHORIZED GENERICNDA017469 | 1 | 5 |
| Pacific Medical Industries LtdUnited States | suspension/ drops | NDA AUTHORIZED GENERICNDA017011 | 1 | 4 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | suspension/ drops | NDA AUTHORIZED GENERICNDA017011 | 1 | 1 |
| NuCare Pharmaceuticals,Inc.United States | suspension/ drops | NDA AUTHORIZED GENERICNDA017011 | 1 | 1 |
| RedPharm DrugUnited States | suspension/ drops | ANDAANDA216935 | 1 | 1 |
Bulk ingredient listings
- EUROAPIFrance · 2 NDC
- Farmabios S.p.A.Italy · 2 NDC
- Henan Lihua Pharmaceutical Co LtdChina · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Symbiotec Pharmalab LimitedIndia · 1 NDC
- Symbiotica Speciality Ingredients Sdn. BhdMalaysia · 1 NDC
- Zhejiang Xianju Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
1 unexpired patent lists prednisolone acetate as the active ingredient, expiring between Oct 2028 and Oct 2028. Application holder: SUN PHARMA CANADA INC.
Enquiry
Common questions
- Who makes prednisolone acetate?
- 10 companies list prednisolone acetate as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Amneal Pharmaceuticals NY LLC, Allergan, Inc., Sportpharm LLC, Lupin 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 PRED FORTE?
- 4 companies list prednisolone acetate 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 prednisolone acetate active ingredient?
- 8 companies list prednisolone acetate as a bulk ingredient, including EUROAPI, Farmabios S.p.A., Henan Lihua Pharmaceutical Co Ltd, MEDISCA Inc..