Angiotensin 2 Receptor Blocker, Calcium Channel Blocker
Where is Amlodipine and Valsartan made?
10 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 6 factories in India and the United States.
India 5United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Lupin Pharmaceuticals, Inc.5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 43386-082, 68180-765, 43386-080 +5 | Lupin LimitedMakes it and packages it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 | |
| Macleods Pharmaceuticals Limited5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 33342-280, 33342-282, 33342-279 +1 | Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | District Solan, India | Problems found, fixed voluntarilyOct 2023 |
| Macleods Pharmaceuticals LimitedMakes it, tests it, packages it and labels it | Dhar, India | Problems found, fixed voluntarilyAug 2024 | |
| Alembic Pharmaceuticals Inc.5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 62332-206, 62332-208, 62332-205 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 46708-459, 46708-461, 46708-458 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Aurobindo Pharma Limited5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 65862-739, 65862-740, 65862-737 +1 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Novel Laboratories, Inc.5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 40032-082, 40032-080, 40032-083 +1 | Novel Laboratories, Inc.Makes it and tests it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Cadila Pharmaceuticals Limited5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 71209-022, 71209-024, 71209-021 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 23155-845, 23155-847, 23155-844 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 0378-1722, 0378-1724, 0378-1721 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novartis Pharmaceuticals Corporation Exforge5 mg / 160 mg, 5 mg / 320 mg, 10 mg / 160 mg, 10 mg / 320 mg · NDC 0078-0489, 0078-0491, 0078-0488 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Amlodipine and 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:
50090-2471 - Golden State Medical Supply, Inc.:
51407-773,51407-774,51407-771,51407-772 - Medsource Pharmaceuticals:
45865-889,45865-882,45865-880,45865-890 - Physicians Total Care, Inc.:
54868-5804,54868-5983,54868-5997,54868-5996
Recalls
- Dec 31, 2018 · Class II · Aurobindo Pharma USA Inc. · 4 recall notices
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.
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. · 3 recall notices
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.