浙江宏元药业股份有限公司
Zhejiang Hongyuan Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
6
6 products shown
🇺🇸 DMF
5
5 products shown
🇪🇺 CEP
2
2 products shown
Total
13
registrations
🇨🇳 CDE 注册 (6)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Atorvastatin Calcium 阿托伐他汀钙 | 134523-00-5 | Class A | Y20190006902 |
| Azilsartan Medoxomil 阿齐沙坦 | 863031-21-4 | Class A | Y20180001453 |
| Bempedoic Acid 贝派度酸 | 738606-46-7 | Class I | Y20250000330 |
| Dapagliflozin HS-10353 | 461432-26-8 | Class A | Y20240000845 |
| Empagliflozin 恩格列净 | 864070-44-0 | Class A | Y20220000943 |
| Ropinirole 盐酸罗匹尼罗 | 91374-21-9 | Class A | Y20220001278 |
🇺🇸 DMF 注册 (5)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Dapagliflozin Intermediate (dp3) | - | - | 2023-12-30 |
| Empagliflozin Advanced Intermidiate (ep2) | - | - | 2023-09-27 |
| L-1/atv-1/(4r-cis)-1,1-dimethylethyl-6-[2-[2-(4-fluorophenyl)-5-(1-isopropyl)-3-phenyl-4-[(phenylamino) Carbonyl]-1h-pyrrol-1-yl] Ethyl]-2,2-dimethyl-1,3-dioxane-4-acetate | 125971-95-1 | - | 2023-08-29 |
| Rosuvastatin Calcium Intermediate (r-2) | - | - | 2023-12-28 |
| Rosuvastatin Calcium Intermediate (r-2) (process 2) | - | - | 2025-12-31 |
🇪🇺 CEP 注册 (2)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Atorvastatin Calcium 阿托伐他汀钙 | 134523-00-5 | CEP 2017-158 - Rev 04 | - |
| Rosuvastatin Calcium 瑞舒伐他汀钙 | 287714-41-4 | CEP 2024-279 - Rev 00 | - |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-04-09 07:23:01