HIKMA ITALIA is an API and finished-dose manufacturer based in United Arab Emirates. It holds 16 active US drug master files across a filed portfolio of 16 molecules. Its filings concentrate with US FDA, EDA (EG) and AIFA (IT). Its GMP standing is certified by EMA, US FDA and EDA (EG). Its most recent recorded inspection, by US FDA, closed on 17 January 2025 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Amman, United Arab Emirates | Not on file |
| Terrugem, United Arab Emirates | Not on file |
| Pavia, United Arab Emirates | Not on file |
| Amman, United Arab Emirates | Not on file |
| Amman, United Arab Emirates | Not on file |
| Amman, United Arab Emirates | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Betamethasone | US FDA | 1 |
| Dasatinib | US FDA | 1 |
| Enalaprilat | US FDA | 1 |
| Erlotinib | US FDA | 1 |
| Glycopyrronium | US FDA | 1 |
| Granisetron | US FDA | 1 |
| Hydrocortisone | US FDA | 1 |
| Methylprednisolone | US FDA | 1 |
| Milrinone | US FDA | 1 |
| Nicardipine | US FDA | 1 |
| Nilotinib | US FDA | 1 |
| Ondansetron | US FDA | 1 |
| Oxandrolone | US FDA | 1 |
| Prednisone | US FDA | 1 |
| Sunitinib | US FDA | 1 |
| Umeclidinium Bromide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 973 | 2 |
| EDA (EG) | 374 | 1 |
| AIFA (IT) | 256 | None |
| Health Canada | 121 | None |
| EDE (AE) | 102 | None |
| DPM (TN) | 68 | None |
| EMA | None | 5 |
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