Nitrogen Binding Agent
Where is Phenylbutyric Acid made?
13 companies sell it under their own name. Their labels name 7 factories in India, the United States and Germany.
India 4United States 2Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Acer Therapeutics Inc. Olpruva2 g, 2 g / 3 g, 3 g, 3 g / 3.67 g · NDC 72542-200, 72542-400, 72542-500 +3 | CU Chemie Uetikon GmbHMakes the active ingredient | Lahr, Germany | Problems found, fixed voluntarilyJan 2025 |
| Glatt Air Techniques, Inc.Makes it | Ramsey, NJ, United States | No problems foundApr 2023 | |
| Aurobindo Pharma Limited1.1 g per 1 mL · NDC 59651-988 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Camber Pharmaceuticals Inc.1.1 g per 1 mL · NDC 31722-605 | Annora Pharma Private LimitedMakes it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Glenmark Pharmaceuticals Inc., USA500 mg · NDC 68462-853 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Navinta LLC1.1 g per 1 mL, 500 mg · NDC 68475-807, 68475-011 | Apothecon Pharmaceuticals Private LimitedMakes it, makes the active ingredient, tests it and packages it | Vadodara, India | Problems found, fixed voluntarilyJan 2023 |
| Novadoz Pharmaceuticals LLC1.1 g per 1 mL · NDC 72205-331 | MSN Pharmaceuticals IncMakes it and tests it | Piscataway, NJ, United States | No problems foundMar 2026 |
| Zydus Pharmaceuticals (USA) Inc.1.1 g per 1 mL, 500 mg · NDC 70710-2193, 70710-2180 | Apothecon Pharmaceuticals Private LimitedMakes it, tests it and packages it | Vadodara, India | Problems found, fixed voluntarilyJan 2023 |
| ENDO USA, Inc.0.94 g per 1 g, 1.1 g per 1 mL, 500 mg · NDC 49884-006, 49884-264, 49884-170 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Horizon Therapeutics USA, Inc. Buphenyl, Ravicti0.94 g per 1 g, 1.1 g per 1 mL, 500 mg · NDC 75987-070, 75987-050, 75987-060 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lupin Pharmaceuticals, Inc. glycerol phenylbutyrate1.1 g per 1 mL · NDC 70748-425 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Medunik Pheburane483 mg per 1 g · NDC 71770-210, 71770-200 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.1.1 g per 1 mL · NDC 0121-1049 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.1.1 g per 1 mL · NDC 0480-3777 | The label doesn't name the factory. Plants this company names for other drugs | ||