Prescription drug
Where is Acamprosate made?
6 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 3 factories in India.
India 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Bionpharma Inc.333 mg · NDC 69452-353 | OrBion Pharmaceuticals Private LimitedMakes it | Kancheepuram, India | No problems foundOct 2025 |
| Glenmark Pharmaceuticals Inc., USA333 mg · NDC 68462-435 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Somerset Therapeutics, LLC333 mg · NDC 70069-860 | Steril-Gene Life Sciences Private LimitedMakes it, tests it, packages it and labels it | Puducherry, India | Serious problems, FDA actionAug 2026 |
| Cadila Healthcare Limited333 mg · NDC 70771-1057 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.333 mg · NDC 0378-6333 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Zydus Pharmaceuticals (USA) Inc.333 mg · NDC 68382-569 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Acamprosate 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:
60687-121 - AvPAK:
50268-028 - Carilion Materials Management:
68151-4760 - Major Pharmaceuticals:
0904-7213 - Marlex Pharmaceuticals, Inc.:
10135-636 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8660 - Remedyrepack Inc.:
70518-4616
Recalls
- Jul 24, 2026 · Class II · Mylan Pharmaceuticals Inc
Failed Dissolution Specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.