Drug factory · FDA FEI 3010820594
Hanhui Pharmaceuticals Co., Ltd.
No.2, Haizheng Road, Xukou Town, Fuyang District, Hangzhou, China
No problems found at FDA's last inspection, Mar 14, 2025.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2015: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrochlorothiazide and Irbesartan | Makes it | Hisun Pharmaceuticals USA Inc. | 42658-141, 42658-142 |
| Irbesartan | Makes it | Hisun Pharmaceuticals USA Inc. | 42658-121, 42658-122, 42658-123 |
| Levetiracetam | Makes it | Hisun Pharmaceuticals USA Inc. | 42658-148, 42658-149 |
| Ticagrelor | Makes it | Hisun Pharmaceuticals USA Inc. | 42658-115 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 14, 2025 | No problems found | Drug Quality Assurance | — |
| Dec 7, 2018 | No problems found | Drug Quality Assurance | — |
| Oct 20, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 25, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture.