Prescription drug
Where is Difluprednate made?
12 companies sell it under their own name and 1 repackager rebottle it. Their labels name 6 factories in India, Italy and Greece.
India 4Italy 1Greece 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.0.5 mg per 1 mL · NDC 69097-341 | Farmabios S.p.A.Makes the active ingredient | Gropello Cairoli, Italy | Problems found, fixed voluntarilyOct 2021 |
| Indoco Remedies LimitedMakes it | Goa, India | Serious problems, FDA actionFeb 2023 | |
| Amneal Pharmaceuticals0.5 mg per 1 mL · NDC 69238-1380 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Caplin Steriles Limited0.5 mg per 1 mL · NDC 65145-161 | Caplin Steriles LimitedMakes it, tests it and packages it | Gummidipoondi, India | No problems foundAug 2024 |
| Dr. Reddy's Laboratories Inc.0.5 mg per 1 mL · NDC 43598-588 | Dr.reddy's Laboratories LimitedMakes it, tests it and packages it | Visakhapatnam, India | Problems found, fixed voluntarilyMay 2024 |
| Exelan Pharmaceuticals, Inc.0.5 mg per 1 mL · NDC 76282-708 | Farmabios S.p.A.Makes the active ingredient | Gropello Cairoli, Italy | Problems found, fixed voluntarilyOct 2021 |
| Leading Pharma, LLC0.5 mg per 1 mL · NDC 69315-329 | Caplin Steriles LimitedMakes it | Gummidipoondi, India | No problems foundAug 2024 |
| Upsher-Smith Laboratories, Inc.0.5 mg per 1 mL · NDC 0832-6054 | Rafarm S.A.Makes it | Paiania, Greece | Problems found, fixed voluntarilyJun 2024 |
| Alembic Pharmaceuticals Inc.0.5 mg per 1 mL · NDC 62332-750 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Alembic Pharmaceuticals Limited0.5 mg per 1 mL · NDC 46708-750 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.5 mg per 1 mL · NDC 0378-7518 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Durezol0.5 mg per 1 mL · NDC 0078-0862 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc. Durezol0.5 mg per 1 mL · NDC 66758-086, 0781-6000 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Difluprednate in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Physicians Total Care, Inc.:
54868-6296
Recalls
- Aug 22, 2022 · Class II · Cipla · 2 recall notices
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility. - Aug 2, 2022 · Class II · Cipla
Lack of Assurance of Sterility: Complaints received of defective container closure. - Jul 14, 2022 · Class II · Cipla
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.