Acs Dobfar is an API and finished-dose manufacturer based in Italy. It holds 160 active US drug master files and 18 valid CEPs. Its filings concentrate with DIGEMAPS (DO), US FDA and MINSA (CR). Its GMP standing is certified by EMA, ANVISA (Brazil) and MFDS (Korea), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 23 November 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Teramo, United Arab Emirates | Not on file |
| Verona, United Arab Emirates | Not on file |
| Pomezia, United Arab Emirates | Not on file |
| POMEZIA (RM), Italy | Not on file |
| TERAMO (TE), Italy | Not on file |
| CASTELLALTO, Italy | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Meropenem | SFDA (Saudi Arabia), US FDA | 15 |
| Ceftazidime | EDQM, US FDA | 13 |
| Ceftriaxone | EDQM, SFDA (Saudi Arabia), US FDA | 11 |
| Imipenem | SFDA (Saudi Arabia), US FDA | 10 |
| Cefotaxime | EDQM, US FDA | 9 |
| Cefuroxime | SFDA (Saudi Arabia), US FDA | 9 |
| Amikacin | US FDA | 8 |
| Ampicillin | US FDA | 8 |
| Cefapirin | US FDA | 8 |
| Cefoxitin | US FDA | 8 |
| Nafcillin | US FDA | 8 |
| Clindamycin | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Cefaclor | EDQM, US FDA | 6 |
| Cilastatin | SFDA (Saudi Arabia), US FDA | 6 |
| Cefazolin | EDQM, US FDA | 5 |
| Cephalexin | EDQM, US FDA | 5 |
| Cefadroxil | US FDA | 4 |
| Cefalotin | US FDA | 4 |
| Cefepime | US FDA | 4 |
| Cefotetan | US FDA | 4 |
| Ceftaroline Fosamil | US FDA | 4 |
| Ceftibuten | US FDA | 4 |
| Ertapenem | US FDA | 4 |
| Gentamicin | US FDA | 4 |
| Piperacillin | US FDA | 4 |
| Sulbactam | US FDA | 4 |
| Tazobactam | US FDA | 4 |
| Cefalexin Monohydrate | EDQM | 2 |
| Amoxicillin Sodium | EDQM | 1 |
| Ampicillin Sodium | EDQM | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DIGEMAPS (DO) | 33 | None |
| US FDA | 20 | 4 |
| MINSA (CR) | 13 | None |
| INVIMA (CO) | 12 | None |
| ARCSA (EC) | 10 | None |
| Health Canada | 7 | None |
| EMA | None | 11 |
| ANVISA (Brazil) | None | 8 |
| MFDS (Korea) | None | 6 |
| NAFDAC (NG) | None | 1 |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
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