Anti-epileptic Agent
Where is Zonisamide made?
13 companies sell it under their own name and 13 repackagers rebottle it. Their labels name 10 factories in India and the United States.
India 6United States 4
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cipla USA., Inc.100 mg · NDC 69097-861 | Cipla LimitedMakes it, tests it, packages it and labels it | Pune, India | Problems found, fixed voluntarilyMay 2024 |
| InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 | |
| InvaGen Pharmaceuticals, IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyJul 2026 | |
| Glenmark Pharmaceuticals Inc., USA25 mg, 50 mg, 100 mg · NDC 68462-130, 68462-128, 68462-129 | Glenmark Pharmaceuticals Inc., USAMakes it and tests it | Monroe, NC, United States | Problems found, fixed voluntarilyJun 2025 |
| Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 | |
| Aurobindo Pharma Limited25 mg, 50 mg, 100 mg · NDC 59651-380, 59651-378, 59651-379 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| BluePoint Laboratories.25 mg, 50 mg, 100 mg · NDC 68001-244, 68001-242, 68001-243 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Cadila Healthcare Limited25 mg, 50 mg, 100 mg · NDC 70771-1144, 70771-1142, 70771-1143 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Caraco Pharmaceutical Laboratories, Ltd.25 mg, 50 mg, 100 mg · NDC 62756-260, 62756-258, 62756-259 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Halol, India | Serious problems, FDA actionJun 2025 |
| Exelan Pharmaceuticals, Inc.25 mg, 50 mg, 100 mg · NDC 76282-228, 76282-226, 76282-227 | InvaGen Pharmaceuticals, IncMakes it and tests it | Hauppauge, NY, United States | No problems foundOct 2023 |
| Praxis, LLC Zonisade100 mg per 5 mL · NDC 59368-407 | Sixarp, LLCMakes it, packages it and labels it | Grand Rapids, MI, United States | No problems foundMar 2025 |
| Unichem Pharmaceuticals (USA), Inc.25 mg, 50 mg, 100 mg · NDC 29300-430, 29300-428, 29300-429 | Unichem Laboratories LimitedMakes it, tests it, packages it and labels it | Bardez, India | Problems found, fixed voluntarilyJul 2024 |
| Viona Pharmaceuticals Inc.25 mg, 50 mg, 100 mg · NDC 72578-042, 72578-040, 72578-041 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Advanz Pharma (US) Corp. Zonegran25 mg, 100 mg · NDC 59212-680, 59212-681 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) Zonisade100 mg per 5 mL · NDC 52652-8001 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Wockhardt Limited25 mg, 50 mg, 100 mg · NDC 55648-990, 55648-945, 55648-946 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Zonisamide 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.
- Advanced Rx Pharmacy of Tennessee, LLC:
80425-0392,80425-0370 - Aidarex Pharmaceuticals LLC:
33261-843,53217-301 - American Health Packaging:
60687-230 - AvPAK:
50268-816 - Bryant Ranch Prepack:
71335-9679,71335-2797,63629-3293,71335-0486+3 - Direct Rx:
61919-775,61919-917,72189-374,72189-624+3 - NCS HealthCare of KY, Inc dba Vangard Labs:
0615-8266 - Physicians Total Care, Inc.:
54868-5789,54868-6221 - Preferred Pharmaceuticals, Inc..:
68788-7438,68788-4004 - Proficient Rx LP:
63187-897,63187-583,71205-727 - Rebel Distributors Corp..:
21695-155,21695-654 - Remedyrepack Inc.:
70518-3224,70518-3903,70518-4600,70518-4349 - Stat Rx USA:
16590-539,16590-724
Recalls
- May 13, 2022 · Class II · Direct Rx
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. - Apr 25, 2022 · Class II · Glenmark Pharmaceuticals Inc., USA · 3 recall notices
cGMP deviations - Aug 27, 2021 · Class II · Glenmark Pharmaceuticals Inc., USA · 2 recall notices
CGMP Deviations
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.