Catechol-O-Methyltransferase Inhibitor
Where is Entacapone made?
11 companies sell it under their own name and 6 repackagers rebottle it. Their labels name 5 factories in India, Finland and China.
India 3Finland 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Wockhardt Limited200 mg · NDC 55648-781, 55648-711, 55648-290 | Orion Corporation, Orion PharmaMakes it | Espoo, Finland | Problems found, fixed voluntarilyNov 2024 |
| Wockhardt LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record | |
| Ajanta Pharma USA Inc.200 mg · NDC 27241-049 | Ajanta Pharma LimitedMakes it | Chhatrapati Sambhajinagar, India | Problems found, fixed voluntarilyApr 2026 |
| Alembic Pharmaceuticals Inc.200 mg · NDC 62332-478 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited200 mg · NDC 46708-478 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited200 mg · NDC 65862-654 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Caraco Pharmaceutical Laboratories, Ltd.200 mg · NDC 47335-007 | Orion Corporation, Orion PharmaMakes it, packages it and labels it | Espoo, Finland | Problems found, fixed voluntarilyNov 2024 |
| Lannett Company, Inc.200 mg · NDC 0527-1830 | Sunshine Lake Pharma Co., Ltd.Makes it | Dongguan, China | Problems found, fixed voluntarilyMar 2024 |
| Rising Pharma Holdings, Inc.200 mg · NDC 64980-722 | Sunshine Lake Pharma Co., Ltd.Makes it | Dongguan, China | Problems found, fixed voluntarilyMar 2024 |
| Wockhardt USA LLC.200 mg · NDC 64679-290 | Orion Corporation, Orion PharmaMakes it | Espoo, Finland | Problems found, fixed voluntarilyNov 2024 |
| Almatica Pharma Inc. Comtan200 mg · NDC 52427-800 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Macleods Pharmaceuticals Limited200 mg · NDC 33342-260 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Entacapone 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.
- American Health Packaging:
60687-188 - Aphena Pharma Solutions - Tennessee, Inc.:
71610-247,43353-996 - AvPAK:
50268-295 - Major Pharmaceuticals:
0904-6822 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8298 - Sandoz Inc.:
0781-5578
Recalls
- Jul 29, 2021 · Class II · The Harvard Drug Group
Failed Dissolution Specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.