Company on the label
Burel Pharmaceuticals, LLC
17 prescription drugs on current FDA listings. Its labels name 8 plants.
Plants named on its labels
| Plant | Where | Role | Last FDA inspection |
|---|---|---|---|
| Elite Laboratories, Inc. | Northvale, NJ, United States | Makes it and labels it | Problems found, fixed voluntarilyAug 2025 |
| VKT Pharma Private Limited | Srikakulam, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyFeb 2025 |
| Rubicon Research Limited | Thane, India | Makes it, tests it, packages it and labels it | No problems foundMar 2024 |
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 2023 |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 2022 |
| Cosette Pharmaceuticals NC Laboratories, LLC | Lincolnton, NC, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJul 2023 |
| Apl Healthcare Limited | Mahabubnagar, India | Makes it and tests it | No problems foundJan 2023 |
| Apl Healthcare Limited | Mahabubnagar, India | Makes it and tests it | No problems foundJan 2023 |
Drugs
- Acetaminophen and Butalbital 35573-455, 35573-456
- Amphetamine and Dextroamphetamine 35573-464, 35573-465, 35573-466 +3
- Betamethasone 35573-107
- Carglumic Acid 35573-459
- Clomiphene 35573-470
- Finasteride 35573-400
- Fluoride Ion 35573-435
- Haloperidol 35573-442, 35573-441
- Ketoconazole 35573-433
- Leflunomide 35573-447, 35573-448
- Levalbuterol 35573-443, 35573-444, 35573-445
- Nicardipine 35573-457, 35573-458
- Pantoprazole 35573-428
- Phenoxybenzamine 35573-473
- Polystyrene Sulfonic Acid 35573-108
- Tadalafil 35573-462, 35573-460, 35573-463 +1
- Triamcinolone Acetonide 35573-404