Hec Pharm is an API and finished-dose manufacturer based in United States. It holds 20 active US drug master files and 3 valid CEPs across a filed portfolio of 19 molecules. Its filings concentrate with AEMPS (ES), EMA and US FDA. Its GMP standing is certified by EMA.
| Site | FDA FEI |
|---|---|
| Yidu, China | Not on file |
| Berlin, Germany | Not on file |
| Plainsboro, United States | 3016779715 |
| Molecule | Regulators | Docs |
|---|---|---|
| Azithromycin | SFDA (Saudi Arabia), US FDA | 2 |
| Entacapone | EDQM, US FDA | 2 |
| Erythromycin | US FDA | 2 |
| Moxifloxacin | EDQM, US FDA | 2 |
| Olanzapine | EDQM, US FDA | 2 |
| Atorvastatin | US FDA | 1 |
| Azilsartan Medoxomil | US FDA | 1 |
| Clarithromycin | US FDA | 1 |
| Duloxetine | US FDA | 1 |
| Escitalopram | US FDA | 1 |
| Esomeprazole | US FDA | 1 |
| Febuxostat | US FDA | 1 |
| Levofloxacin | US FDA | 1 |
| Lincomycin | US FDA | 1 |
| Metoprolol | US FDA | 1 |
| Olmesartan | US FDA | 1 |
| Tenofovir Disoproxil | US FDA | 1 |
| Ticagrelor | US FDA | 1 |
| Zidovudine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AEMPS (ES) | 41 | None |
| EMA | 27 | 4 |
| US FDA | 27 | None |
| MPA (SE) | 5 | None |
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