Angiotensin 2 Receptor Blocker
Where is Valsartan made?
26 companies sell it under their own name and 16 repackagers rebottle it. Their labels name 19 factories in India, the United States and Bangladesh.
India 13United States 5Bangladesh 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals40 mg, 80 mg, 160 mg, 320 mg · NDC 53746-839, 65162-839, 53746-840 +5 | Amneal Pharmaceuticals Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJan 2025 |
| Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 | |
| Aurobindo Pharma Limited40 mg, 80 mg, 160 mg, 320 mg · NDC 65862-572, 65862-573, 65862-570 +1 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Aurolife Pharma LLCMakes it and tests it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 | |
| Macleods Pharmaceuticals Limited40 mg, 80 mg, 160 mg, 320 mg · NDC 33342-064, 33342-065, 33342-062 +1 | 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 | |
| ANI Pharmaceuticals, Inc.4 mg per 1 mL · NDC 70954-310 | Novitium Pharma LLCMakes it, tests it, packages it and labels it | East Windsor, NJ, United States | No problems foundFeb 2024 |
| Advagen Pharma Ltd.4 mg per 1 mL · NDC 72888-184 | Rubicon Research LimitedMakes it, tests it, packages it and labels it | Satara, India | Not inspected on record |
| Alembic Pharmaceuticals Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 62332-046, 62332-047, 62332-044 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited40 mg, 80 mg, 160 mg, 320 mg · NDC 46708-046, 46708-047, 46708-044 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Ascend Laboratories, LLC40 mg, 80 mg, 160 mg, 320 mg · NDC 67877-417, 67877-418, 67877-415 +1 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| Cadila Healthcare Limited40 mg, 80 mg, 160 mg, 320 mg · NDC 70771-1884, 70771-1885, 70771-1882 +1 | Zydus Pharmaceuticals LimitedMakes it and tests it | Matoda, India | Not inspected on record |
| Camber Pharmaceuticals Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 31722-747, 31722-153, 31722-748 +5 | Hetero Labs LimitedMakes it | Mahabubnagar, India | Problems found, fixed voluntarilyAug 2022 |
| Dr.Reddy's Laboratories Ltd.40 mg, 80 mg, 160 mg, 320 mg · NDC 55111-733, 55111-734, 55111-731 +1 | Dr. Reddy's Laboratories LimitedMakes it and tests it | Medchal-Malkajgiri, India | Problems found, fixed voluntarilyOct 2023 |
| Jubilant Cadista Pharmaceuticals Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 59746-362, 59746-393, 59746-360 +1 | Jubilant Generics LimitedMakes it | Roorkee, India | Problems found, fixed voluntarilyFeb 2024 |
| Laurus Labs Limited40 mg, 80 mg, 160 mg, 320 mg · NDC 42385-991, 42385-992, 42385-989 +1 | Laurus Labs LimitedMakes it, makes the active ingredient and tests it | Anakapalli, India | Problems found, fixed voluntarilyFeb 2023 |
| Lupin Pharmaceuticals, Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 68180-278, 68180-279, 68180-276 +1 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Ohm Laboratories Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 51660-142, 51660-143, 51660-140 +1 | Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 |
| ScieGen Pharmaceuticals, Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 50228-133, 50228-132, 50228-135 +1 | ScieGen Pharmaceuticals, INC.Makes it and tests it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMay 2026 |
| Square Pharmaceuticals Limited40 mg, 80 mg, 160 mg, 320 mg · NDC 76483-024, 76483-025, 76483-026 +1 | Square Pharmaceuticals Plc.Makes it, tests it, packages it and labels it | Gazipur, Bangladesh | Problems found, fixed voluntarilyJan 2020 |
| Viona Pharmaceuticals Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 72578-133, 72578-134, 72578-131 +1 | Zydus Pharmaceuticals LimitedMakes it and tests it | Matoda, India | Not inspected on record |
| AptaPharma Inc. Prexxartan4 mg per 1 mL · NDC 76281-155 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 42291-858, 42291-859, 42291-856 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Lifsa Drugs LLC4 mg per 1 mL · NDC 72336-910 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 10135-770, 10135-771, 10135-768 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 0378-5814, 0378-5815, 0378-5807 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Diovan40 mg, 80 mg, 160 mg, 320 mg · NDC 0078-0359, 0078-1252, 0078-0360 +4 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solco Healthcare U.S., LLC40 mg, 80 mg, 160 mg, 320 mg · NDC 43547-369, 43547-370, 43547-367 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Unichem Pharmaceuticals (USA), Inc.40 mg, 80 mg, 160 mg, 320 mg · NDC 29300-234, 29300-235, 29300-232 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Valsartan 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:
50090-4295,50090-2550,50090-4837,50090-5191+14 - American Health Packaging:
60687-634,60687-612,60687-623 - Aphena Pharma Solutions - Tennessee, Inc.:
67544-404,43353-203,53401-033,67544-403+1 - AvPAK:
50268-748,50268-749,50268-746,50268-747 - Bryant Ranch Prepack:
71335-1436,71335-2248,71335-2154,71335-3186+9 - Carilion Materials Management:
68151-5044,68151-4349 - Coupler LLC:
67046-1574,67046-1142,67046-1596 - Direct Rx:
72189-050,72189-049,72189-550 - Kesin Pharma Corporation:
81033-108,81033-109,81033-106,81033-107 - Medsource Pharmaceuticals:
45865-114,45865-101 - Northwind Pharmaceuticals:
51655-244,51655-834,51655-456,51655-695+3 - PD-Rx Pharmaceuticals, Inc.:
72789-281,72789-553 - Physicians Total Care, Inc.:
54868-4645,54868-6452,54868-5082,54868-6453+3 - Proficient Rx LP:
82804-154,63187-655,71205-301 - Rebel Distributors Corp..:
21695-918,21695-919,21695-917 - Unit Dose Services:
50436-2168
Recalls
- Aug 4, 2026 · Class II · Novartis Pharmaceuticals Corporation
Failed Dissolution Specifications - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - Dec 31, 2018 · Class II · Aurobindo Pharma USA 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. - Dec 31, 2018 · Class II · Aurobindo Pharma USA Inc. · 4 recall notices
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - Dec 4, 2018 · Class II · Mylan Laboratories Limited, (Nashik FDF) · 4 recall notices
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. - Nov 20, 2018 · Class II · Mylan Pharmaceuticals Inc. · 4 recall notices
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. - Aug 14, 2018 · Class III · Jubilant Cadista Pharmaceuticals, Inc. · 3 recall notices
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing. - Aug 8, 2018 · Class II · Hetero Labs Limited Unit V · 4 recall notices
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Jul 27, 2018 · Class II · Bryant Ranch Prepack Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Jul 13, 2018 · Class II · Prinston Pharmaceutical Inc · 4 recall notices
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. - Nov 29, 2017 · Class II · Prinston Pharmaceutical Inc
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.