Bayer S/A is an API and finished-dose manufacturer based in United Arab Emirates. It holds 26 active US drug master files across a filed portfolio of 20 molecules. Its filings concentrate with ANVISA (Brazil), Health Canada and EMA. Its GMP standing is certified by BPOM (ID), ZLG (DE) and COFEPRIS (MX), among 11 authorities. Its most recent recorded inspection, by US FDA, closed on 20 July 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Berlin, United Arab Emirates | Not on file |
| Leverkusen, United Arab Emirates | Not on file |
| Garbagnate Milanese, United Arab Emirates | Not on file |
| Turku, United Arab Emirates | Not on file |
| Casablanca, United Arab Emirates | Not on file |
| BUENOS AIRES, Argentina | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Ciprofloxacin | US FDA | 3 |
| Azelaic Acid | US FDA | 2 |
| Norethisterone | US FDA | 2 |
| Rivaroxaban | US FDA | 2 |
| Testosterone | US FDA | 2 |
| Acarbose | US FDA | 1 |
| Dienogest | US FDA | 1 |
| Drospirenone | US FDA | 1 |
| Estradiol | US FDA | 1 |
| Estradiol Valerate | US FDA | 1 |
| Ethinylestradiol | US FDA | 1 |
| Gadobutrol | US FDA | 1 |
| Iloprost | US FDA | 1 |
| Iopromide | US FDA | 1 |
| Levonorgestrel | US FDA | 1 |
| Medroxyprogesterone Acetate | US FDA | 1 |
| Molidustat | US FDA | 1 |
| Norgestrel | US FDA | 1 |
| Testosterone Enanthate | US FDA | 1 |
| Testosterone Undecanoate | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ANVISA (Brazil) | 424 | 5 |
| Health Canada | 419 | None |
| EMA | 364 | 7 |
| INHRR (VE) | 341 | None |
| MHRA (UK) | 291 | 2 |
| AIFA (IT) | 269 | None |
| BPOM (ID) | None | 12 |
| ZLG (DE) | None | 10 |
| COFEPRIS (MX) | None | 8 |
| HSA (SG) | None | 4 |
| TMDA (TZ) | None | 4 |
| MFDS (Korea) | None | 4 |
| NAFDAC (NG) | None | 2 |
| US FDA | None | 1 |
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