浙江江北药业有限公司
Zhejiang Jiangbei Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
9
12 products shown
🇺🇸 DMF
7
7 products shown
🇪🇺 CEP
9
10 products shown
Total
25
registrations
🇨🇳 CDE 注册 (12)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Atorvastatin Calcium 阿托伐他汀钙 | 134523-00-5 | Class A | Y20170000432 |
| Clopidogrel 氯吡格雷 | 113665-84-2 | Class I | Y20170000089 |
| Efavirenz 依非韦伦 | 154598-52-4 | Class A | Y20190009799 |
| Esomeprazole 埃索美拉唑镁 | 119141-88-7 | Class I | Y20170001319 |
| Levetiracetam 左乙拉西坦 | 102767-28-2 | Class A | Y20180001065 |
| Linezolid 利奈唑胺 | 165800-03-3 | Class I | Y20190021444 |
| Rosuvastatin Calcium 瑞舒伐他汀钙 | 287714-41-4 | Class A | Y20220000289 |
| Rosuvastatin Calcium 瑞舒伐他汀钙 | 287714-41-4 | Class A | Y20170001629 |
| Simvastatin 辛伐他汀 | 79902-63-9 | Class A | Y20190009704 |
| Simvastatin 辛伐他汀 | 79902-63-9 | Class A | Y20180001496 |
| Sitagliptin 西格列汀 | 486460-32-6 | Class A | Y20210000925 |
| Sitagliptin 西格列汀 | 486460-32-6 | Class I | Y20210000387 |
🇺🇸 DMF 注册 (7)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Atorvastatin Calcium 阿托伐他汀钙 | 134523-00-5 | 31764 | 2017-04-18 |
| Efavirenz 依非韦伦 | 154598-52-4 | 31400 | 2017-01-16 |
| Levetiracetam 左乙拉西坦 | 102767-28-2 | 34222 | 2019-12-10 |
| Simvastatin 辛伐他汀 | 79902-63-9 | 26971 | 2013-03-04 |
| Simvastatin (with 0.01% Bha) 辛伐他汀无润滑剂颗粒 | 79902-63-9 | 28583 | 2014-08-18 |
| Simvastatin Ammonium Salt | 139893-43-9 | 24935 | 2011-05-10 |
| Simvastatin Ammonium Salt (alternative Process) | 139893-43-9 | 26088 | 2012-05-16 |
🇪🇺 CEP 注册 (10)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Atorvastatin Calcium 阿托伐他汀钙 | 134523-00-5 | CEP 2014-160 - Rev 02 | 2024-02-12 |
| Atorvastatin Calcium, Im2 Process | 134523-03-8 | CEP 2021-383 - Rev 02 | 2024-09-20 |
| Clopidogrel Hydrogen Sulfate | 120202-66-6 | R0-CEP 2016-084 - Rev 00 | 2017-09-27 |
| Levetiracetam 左乙拉西坦 | 102767-28-2 | R1-CEP 2012-084 - Rev 03 | 2020-09-01 |
| Rosuvastatin Calcium 瑞舒伐他汀钙 | 287714-41-4 | R0-CEP 2020-346 - Rev 00 | 2023-01-20 |
| Rosuvastatin Calcium 瑞舒伐他汀钙 | 287714-41-4 | R0-CEP 2015-303 - Rev 00 | 2017-10-30 |
| Simvastatin 辛伐他汀 | 79902-63-9 | R1-CEP 2005-255 - Rev 03 | 2018-11-27 |
| Simvastatin, Antioxidant Butylated Hydroxyanisole 辛伐他汀无润滑剂颗粒 | 79902-63-9 | R1-CEP 2013-025 - Rev 03 | 2019-07-17 |
| Simvastatin, Process II 辛伐他汀无润滑剂颗粒 | 79902-63-9 | R0-CEP 2021-401 - Rev 00 | 2023-04-19 |
| Simvastatin, Process II, With Butylated Hydroxyanisole 0.010% 辛伐他汀无润滑剂颗粒 | 79902-63-9 | R0-CEP 2021-405 - Rev 00 | 2023-04-18 |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-09-11 06:00:12