Angiotensin 2 Receptor Blocker, Calcium Channel Blocker
Where is Amlodipine and Telmisartan made?
4 companies sell it under their own name. Their labels name 2 factories in India.
India 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Alembic Pharmaceuticals Inc.5 mg / 40 mg, 5 mg / 80 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 62332-185, 62332-187, 62332-184 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Alembic Pharmaceuticals Limited5 mg / 40 mg, 5 mg / 80 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 46708-185, 46708-187, 46708-184 +1 | Alembic Pharmaceuticals LimitedMakes it | Panchmahal, India | No problems foundJul 2024 |
| Lupin Pharmaceuticals, Inc.5 mg / 40 mg, 5 mg / 80 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 68180-197, 68180-199, 68180-196 +1 | Lupin LimitedMakes it | Salcette, India | Problems found, fixed voluntarilyNov 2025 |
| Mylan Pharmaceuticals Inc.5 mg / 40 mg, 5 mg / 80 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 0378-1076, 0378-1078, 0378-1075 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Oct 1, 2026 · Class III · Viatris, Inc.
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications - Apr 1, 2019 · Class III · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.