HEC Pharm is an API and finished-dose manufacturer based in China. It holds 43 active US drug master files and 4 valid CEPs. Its filings concentrate with AEMPS (ES), US FDA and EMA. Its GMP standing is certified by EMA, US FDA and ZLG (DE). Its most recent recorded inspection, by US FDA, closed on 22 November 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Yidu City, China | Not on file |
| China, China | 3018718574 |
| Yidu, China | Not on file |
| China, China | 3009740510 |
| Shaoguan City, Ruyuan County, Guangdong Province, China | Not on file |
| China, China | 3015516273 |
3 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Clarithromycin | SFDA (Saudi Arabia), US FDA | 4 |
| Erythromycin | US FDA | 4 |
| Sitagliptin | SFDA (Saudi Arabia), US FDA | 4 |
| Azithromycin | SFDA (Saudi Arabia), US FDA | 3 |
| Entacapone | EDQM, US FDA | 3 |
| Escitalopram | US FDA | 3 |
| Moxifloxacin | EDQM, US FDA | 3 |
| Olanzapine | EDQM, US FDA | 3 |
| Atorvastatin | US FDA | 2 |
| Azilsartan Medoxomil | US FDA | 2 |
| Duloxetine | US FDA | 2 |
| Esomeprazole | US FDA | 2 |
| Febuxostat | US FDA | 2 |
| Fingolimod | SFDA (Saudi Arabia), US FDA | 2 |
| Levofloxacin | US FDA | 2 |
| Lincomycin | US FDA | 2 |
| Metoprolol | US FDA | 2 |
| Olmesartan | US FDA | 2 |
| Rosuvastatin | US FDA | 2 |
| Tenofovir Disoproxil | US FDA | 2 |
| Ticagrelor | US FDA | 2 |
| Zidovudine | US FDA | 2 |
| Alogliptin | US FDA | 1 |
| Apixaban | US FDA | 1 |
| Apremilast | US FDA | 1 |
| Aripiprazole | US FDA | 1 |
| Brivaracetam | US FDA | 1 |
| Finerenone | US FDA | 1 |
| Linagliptin | US FDA | 1 |
| Linagliptin And | SFDA (Saudi Arabia) | 1 |
| Moxifloxacin Hydrochloride | EDQM | 1 |
| Oseltamivir | US FDA | 1 |
| Prasugrel | US FDA | 1 |
| Ritonavir | US FDA | 1 |
| Rivaroxaban | US FDA | 1 |
| Sofosbuvir | SFDA (Saudi Arabia) | 1 |
| Solifenacin Succinate | US FDA | 1 |
| Sugammadex | US FDA | 1 |
| Tadalafil | US FDA | 1 |
| Vonoprazan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| AEMPS (ES) | 41 | None |
| US FDA | 35 | 2 |
| EMA | 27 | 9 |
| MPA (SE) | 5 | None |
| ARCSA (EC) | 3 | None |
| JFDA (JO) | 3 | None |
| ZLG (DE) | None | 2 |
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.
Choose your molecules and target markets. HEC Pharm comes back tiered against every other supplier able to file there.
Start for freeRanked by shared active ingredients where we have them, otherwise by country and comparable credentials.