Bausch Health Companies is an API and finished-dose manufacturer based in Canada. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its filings concentrate with US FDA, HSA (SG) and ARCSA (EC). Its GMP standing is certified by ZLG (DE), EMA and US FDA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 19 January 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| STEINBACH, Canada | Not on file |
| Canada, Canada | 3002807186 |
| Canada, Canada | 3002806613 |
| Werne, Germany | Not on file |
| Terrugem, Portugal | Not on file |
| Conshohocken, United States | 3004459493 |
| Molecule | Regulators | Docs |
|---|---|---|
| Metformin | US FDA | 1 |
| Pirbuterol | US FDA | 1 |
| Pyridostigmine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 208 | 2 |
| HSA (SG) | 143 | 2 |
| ARCSA (EC) | 4 | None |
| MINSA (CR) | 2 | None |
| DMP (NO) | 1 | None |
| INVIMA (CO) | 1 | None |
| ZLG (DE) | None | 8 |
| EMA | None | 2 |
| ANVISA (Brazil) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2017 | $2.2B | Not reported | Not reported |
| 2016 | $2.4B | Not reported | Not reported |
| 2015 | $2.8B | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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