Vasopressin V2 Receptor Antagonist
Where is Tolvaptan made?
9 companies sell it under their own name. Their labels name 9 factories in India and Japan.
India 5Japan 4
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Otsuka America Pharmaceutical, Inc. Jynarque, Samsca15 mg, 15 mg / 30 mg, 15 mg / 45 mg, 30 mg, 30 mg / 60 mg, 30 mg / 90 mg · NDC 59148-079, 59148-082, 59148-020 +6 | Otsuka Pharmaceutical Co LtdMakes it and tests it | Itano-gun, Japan | No problems foundOct 2025 |
| Otsuka Pharmaceutical Co LtdMakes the active ingredient and tests it | Tokushima, Japan | Problems found, fixed voluntarilyMar 2024 | |
| Otsuka Pharmaceutical Co LtdMakes it and tests it | Tokushima, Japan | No problems foundMay 2025 | |
| Otsuka Pharmaceutical Co., Ltd.Makes the active ingredient and tests it | Kanzaki-gun, Japan | Problems found, fixed voluntarilyJul 2025 | |
| Ascend Laboratories, LLC15 mg, 15 mg / 30 mg, 15 mg / 45 mg, 30 mg, 30 mg / 60 mg, 30 mg / 90 mg · NDC 67877-635, 67877-915, 67877-920 +10 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 | |
| Camber Pharmaceuticals Inc.15 mg, 30 mg · NDC 31722-868, 31722-869 | Annora Pharma Private LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilyMar 2025 |
| Lupin Pharmaceuticals, Inc.15 mg, 15 mg / 30 mg, 15 mg / 45 mg, 30 mg, 30 mg / 60 mg, 30 mg / 90 mg · NDC 70748-240, 70748-238, 70748-241 +4 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Northstar Rx LLC.15 mg, 30 mg · NDC 72603-932, 72603-933 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Novadoz Pharmaceuticals LLC15 mg, 30 mg · NDC 72205-130, 72205-131 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| Apotex Corp.15 mg, 15 mg / 30 mg, 15 mg / 45 mg, 30 mg, 30 mg / 60 mg, 30 mg / 90 mg · NDC 60505-4317, 60505-4781, 60505-4800 +6 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Par Health USA, LLC15 mg, 30 mg · NDC 49884-768, 49884-770 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.15 mg, 15 mg / 30 mg, 15 mg / 45 mg, 30 mg / 60 mg, 30 mg / 90 mg · NDC 0480-3414, 0480-3311, 0480-3312 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||