Angiotensin 2 Receptor Blocker
Where is Azilsartan made?
3 companies sell it under their own name. Their labels name 2 factories in India and Ireland.
India 1Ireland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Lupin Pharmaceuticals, Inc.40 mg, 80 mg · NDC 70748-236, 70748-237 | Lupin LimitedMakes it and packages it | Nagpur, India | Problems found, fixed voluntarilyJul 2023 |
| Wilshire Pharmaceuticals Inc. Azilsartan Medoxomil40 mg, 80 mg · NDC 52536-004, 52536-008 | Takeda Ireland LimitedMakes it, tests it, packages it and labels it | Bray, Ireland | Problems found, fixed voluntarilyDec 2022 |
| Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) Edarbi40 mg, 80 mg · NDC 60631-040, 60631-080 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.