Bayer HealthCare is a finished-dose manufacturer based in United States. It appears in 540 regulatory filings across 21 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), DH (HK) and ANSM (FR). Its GMP standing is certified by ANSM (FR), US FDA and NAFDAC (NG), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 20 October 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| LONS, France | Not on file |
| Gaillard, France | Not on file |
| BERKELEY, United States | Not on file |
| Myerstown, United States | 2510692 |
| Berkeley, United States | 2910913 |
| Morristown, United States | 2243252 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| DIGEMAPS (DO) | 122 | None |
| DH (HK) | 86 | None |
| ANSM (FR) | 83 | 11 |
| EMA | 60 | 1 |
| EDA (EG) | 47 | None |
| Health Canada | 35 | None |
| US FDA | None | 3 |
| NAFDAC (NG) | None | 1 |
| ANVISA (Brazil) | None | 1 |
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