Hp Halden Pharma is a finished-dose manufacturer based in Norway. It appears in 21 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), EDE (AE) and DIGEMAPS (DO). Its GMP standing is certified by ANVISA (Brazil), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 10 May 2023 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Halden, United Arab Emirates | Not on file |
| HALDEN, Norway | Not on file |
| Norway, Norway | 3002608066 |
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 6 | None |
| EDE (AE) | 5 | None |
| DIGEMAPS (DO) | 3 | None |
| US FDA | 3 | 1 |
| MINSA (CR) | 3 | None |
| INVIMA (CO) | 1 | None |
| ANVISA (Brazil) | None | 2 |
| EMA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2024 | $117.4M | Not reported | Not reported |
Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.
Choose your molecules and target markets. Hp Halden Pharma comes back tiered against every other supplier able to file there.
Start for free