Nonsteroidal Anti-inflammatory Drug
Where is Bromfenac made?
14 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 8 factories in India, the United States and Switzerland.
India 5United States 2Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Inc.0.805 mg per 1 mL, 1.035 mg per 1 mL · NDC 62332-583, 62332-508 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Akorn1.035 mg per 1 mL · NDC 50383-249 | AkornMakes it | Location not on file | Not inspected on record |
| Alembic Pharmaceuticals Limited0.805 mg per 1 mL, 1.035 mg per 1 mL · NDC 46708-583, 46708-508 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Amneal Pharmaceuticals0.7 mg per 1 mL · NDC 60219-1526 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and sterilizes it | Ahmedabad, India | No problems foundJun 2024 |
| Armas Pharmaceuticals Inc.1.035 mg per 1 mL · NDC 72485-649 | Ophtapharm AGMakes it | Hettlingen, Switzerland | Problems found, fixed voluntarilyFeb 2020 |
| Aurobindo Pharma Limited0.9 mg per 1 mL · NDC 65862-789 | Eugia Pharma Specialities LimitedMakes it and tests it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Bausch & Lomb Americas Inc.0.7 mg per 1 mL · NDC 82260-602 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Bausch & Lomb Incorporated Prolensa0.7 mg per 1 mL · NDC 24208-602 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Caraco Pharmaceutical Laboratories, Ltd. Bromsite 0.075%0.76 mg per 1 mL · NDC 49708-754, 49708-755 | Woodstock Sterile Solutions, Inc.Makes it, tests it, packages it and labels it | Woodstock, IL, United States | No problems foundOct 2022 |
| Dr. Reddy's Laboratories Inc.0.7 mg per 1 mL · NDC 75907-093 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Gland Pharma Limited0.9 mg per 1 mL · NDC 68083-313 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Lupin Pharmaceuticals, Inc.0.75 mg per 1 mL, 0.805 mg per 1 mL, 0.9 mg per 1 mL · NDC 68180-434, 68180-433, 68180-436 | Lupin LimitedMakes it and packages it | Pithampur, India | Serious problems, FDA actionJul 2025 |
| Apotex Corp.0.7 mg per 1 mL · NDC 60505-1006 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fosun Pharma USA Inc.0.9 mg per 1 mL · NDC 72266-142 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Bromfenac 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.:
54868-6301,54868-6343 - Unit Dose Services:
50436-6301
Recalls
- May 7, 2025 · Class II · Alembic Pharmaceuticals Limited
Failed Impurities/Degradation Specifications - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Jan 24, 2019 · Class II · Sun Pharmaceutical Industries, Inc.
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.