Angiotensin 2 Receptor Blocker
Where is Irbesartan made?
17 companies sell it under their own name and 8 repackagers rebottle it. Their labels name 18 factories in India, the United States, France, China and Hungary.
India 9United States 3France 3China 2Hungary 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sanofi-Aventis U.S. LLC Avapro150 mg, 300 mg · NDC 0024-5851, 0024-5852 | EUROAPI Hungary Ltd.Makes the active ingredient and tests it | Budapest, Hungary | No problems foundJun 2019 |
| Sanofi Winthrop IndustrieMakes it, tests it, packages it and labels it | Tours, France | Problems found, fixed voluntarilyJan 2023 | |
| Sanofi Winthrop IndustrieMakes it and tests it | Ambares Et Lagrave, France | Problems found, fixed voluntarilyNov 2023 | |
| Sanofi Winthrop IndustrieMakes the active ingredient and tests it | Aramon, France | Problems found, fixed voluntarilyMar 2023 | |
| Camber Pharmaceuticals Inc.75 mg, 150 mg, 300 mg · NDC 31722-161, 31722-730, 31722-162 +3 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| ScieGen Pharmaceuticals, INC.Makes it, tests it and packages it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 | |
| Jubilant Cadista Pharmaceuticals Inc.75 mg, 150 mg, 300 mg · NDC 59746-448, 59746-449, 59746-447 | Havix Group Inc d/b/a Aavis PharmaceuticalsMakes it | Hoschton, GA, United States | Problems found, fixed voluntarilyJul 2025 |
| Jubilant Generics LimitedMakes it | Roorkee, India | Problems found, fixed voluntarilyFeb 2024 | |
| Macleods Pharmaceuticals Limited75 mg, 150 mg, 300 mg · NDC 33342-048, 33342-049, 33342-047 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 |
| Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Dhar, India | Problems found, fixed voluntarilyAug 2024 | |
| Northstar Rx LLC.75 mg, 150 mg, 300 mg · NDC 72603-671, 72603-672, 72603-670 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Daman, India | Problems found, fixed voluntarilyMay 2023 |
| Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Dhar, India | Problems found, fixed voluntarilyAug 2024 | |
| Alembic Pharmaceuticals Inc.75 mg, 150 mg, 300 mg · NDC 62332-042, 62332-043, 62332-041 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited75 mg, 150 mg, 300 mg · NDC 46708-440, 46708-441, 46708-439 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Amneal Pharmaceuticals75 mg, 150 mg, 300 mg · NDC 65162-285, 65162-286, 65162-284 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Aurobindo Pharma Limited75 mg, 150 mg, 300 mg · NDC 65862-638, 65862-639, 65862-637 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Chartwell RX, LLC.75 mg, 150 mg, 300 mg · NDC 62135-977, 62135-978, 62135-976 | Chartwell Pharmaceuticals Congers, LLC.Makes it | Congers, NY, United States | Serious problems, FDA actionNov 2025 |
| Hisun Pharmaceuticals USA Inc.75 mg, 150 mg, 300 mg · NDC 42658-122, 42658-123, 42658-121 | Hanhui Pharmaceuticals Co., Ltd.Makes it | Hangzhou, China | No problems foundMar 2025 |
| Lupin Pharmaceuticals, Inc.75 mg, 150 mg, 300 mg · NDC 68180-411, 68180-412, 68180-410 | Lupin LimitedMakes it | Pithampur, India | Serious problems, FDA actionJul 2025 |
| Novadoz Pharmaceuticals LLC75 mg, 150 mg, 300 mg · NDC 72205-328, 72205-329, 72205-327 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy (District), India | Problems found, fixed voluntarilyJun 2024 |
| ScieGen Pharmaceuticals, Inc.75 mg, 150 mg, 300 mg · NDC 50228-161, 50228-162, 50228-160 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Solco Healthcare U.S., LLC75 mg, 150 mg, 300 mg · NDC 43547-375, 43547-376, 43547-374 | Zhejiang Huahai Pharmaceutical Co., Ltd.Makes it | Linhai, China | Serious problems, FDA actionApr 2026 |
| AvKARE, Inc.75 mg, 150 mg, 300 mg · NDC 42291-941, 42291-942, 42291-940 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.75 mg, 150 mg, 300 mg · NDC 29300-213, 29300-214, 29300-212 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Irbesartan 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.
- A-S Medication Solutions:
50090-1284,50090-3431,50090-4519,50090-5055+4 - Bryant Ranch Prepack:
71335-0423,71335-2168,72162-2355,72162-2354+8 - Direct Rx:
72189-205,72189-270,72189-201 - Lake Erie Medical DBA Quality Care Products LLC:
83008-084,83008-085 - Physicians Total Care, Inc.:
54868-4199,54868-4414 - Preferred Pharmaceuticals, Inc..:
68788-8670 - Proficient Rx LP:
71205-082,63187-737,71205-452,71205-379 - Remedyrepack Inc.:
70518-1690,70518-2245,70518-2246,70518-1543+1
Recalls
- Jul 18, 2022 · Class II · Jubilant Cadista Pharmaceuticals, Inc.
Failed Dissolution Specifications - Jul 18, 2022 · Class II · Jubilant Cadista Pharmaceuticals, Inc.
Failed dissolution specifications. - Oct 12, 2021 · Class II · Lupin Pharmaceuticals Inc. · 3 recall notices
CGMP Deviations: impurity N-nitrosoirbesartan detected in API - Jan 18, 2019 · Class II · Prinston Pharmaceutical Inc
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.