山东诚汇双达药业有限公司
Shandong Chenghui Shuangda Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
25
27 products shown
🇺🇸 DMF
7
7 products shown
🇪🇺 CEP
8
8 products shown
Total
40
registrations
🇨🇳 CDE 注册 (27)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Apalutamide 阿帕他胺 | 956104-40-8 | Class A | Y20240001176 |
| Articaine, Combinations 盐酸阿替卡因 | - | Class A | Y20230000440 |
| Baloxavir Marboxil 玛巴洛沙韦 | 1985606-14-1 | Class I | Y20250001001 |
| Bupivacaine 盐酸布比卡因 | 38396-39-3 | Class A | Y20230000841 |
| Bupivacaine Hydrochloride 布比卡因 | - | Class I | Y20240001283 |
| Celecoxib 塞来昔布 | 169590-42-5 | Class A | Y20170000787 |
| Crisaborole 克立硼罗 | 906673-24-3 | Class A | Y20230000985 |
| Dapagliflozin HS-10353 | 461432-26-8 | Class A | Y20240000916 |
| Finerenone HS236 | 1050477-31-0 | Class I | Y20250000977 |
| Lacidipine 拉西地平 | 103890-78-4 | Class A | Y20210000356 |
| Letermovir 来特莫韦 | 917389-32-3 | Class A | Y20240000270 |
| Lidocaine 利多卡因 | 137-58-6 | Class A | Y20200000994 |
| Lidocaine 利多卡因 | 137-58-6 | Class A | Y20200000212 |
| Ozagrel Sodium 奥扎格雷钠 | 82571-53-7 | Class A | Y20200001289 |
| Potassium Sulfate 硫酸钾 | 7778-80-5 | Class A | Y20240000755 |
| Prilocaine, Combinations 丙胺卡因 | - | Class A | Y20200001098 |
| Ropivacaine 盐酸罗哌卡因 | 84057-95-4 | Class A | Y20220000839 |
| Ruxolitinib 磷酸芦可替尼 | 941678-49-5 | Class I | Y20250000861 |
| Sodium Sulfate 硫酸钠 | 7757-82-6 | Class A | Y20240000756 |
| Sugammadex Sodium 舒更葡糖钠 | 343306-71-8 | Class A | Y20200001107 |
| Tadalafil 他达拉非 | 171596-29-5 | Class A | Y20240001046 |
| Tetracaine 盐酸丁卡因 | 136-47-0 | Class A | Y20210000732 |
| Tetracaine 盐酸丁卡因 | 136-47-0 | Class I | Y20200001041 |
| Tolvaptan 托伐普坦喷雾干燥粉末 | 150683-30-0 | Class I | Y20250001132 |
| Upadacitinib 乌帕替尼 | 1310726-60-3 | Class I | Y20250000947 |
| Urapidil 盐酸乌拉地尔 | 34661-75-1 | Class A | Y20200001409 |
| Vonoprazan 富马酸伏诺拉生 | 881681-00-1 | Class A | Y20230000546 |
🇺🇸 DMF 注册 (7)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Enoxaparin Sodium USP 依诺肝素钠 | 679809-58-6 | 28665 | 2014-09-23 |
| Heparin Sodium 肝素钠 | 9041-08-1 | 29353 | 2015-05-06 |
| Nadroparin Calcium 那屈肝素钙 | 37270-89-6 | 31703 | 2017-04-21 |
| Pramoxine Hydrochloride | 637-58-1 | 37519 | 2022-09-15 |
| Prilocaine Hydrochloride | 1786-81-8 | 34701 | 2020-03-30 |
| Tetracaine 盐酸丁卡因 | 136-47-0 | 35615 | 2021-02-04 |
| Vonoprazan Fumarate 富马酸伏诺拉生 | 881681-01-2 | 39107 | 2023-11-02 |
🇪🇺 CEP 注册 (8)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Articaine Hydrochloride | 23964-57-0 | CEP 2023-255 - Rev 01 | 2025-11-13 |
| Lidocaine 利多卡因 | 137-58-6 | CEP 2024-285 - Rev 00 | 2025-10-09 |
| Lidocaine Hydrochloride Monohydrate | 6108-05-0 | CEP 2024-340 - Rev 00 | 2025-11-10 |
| Meldonium Dihydrate 米屈肼二水合物 | 86426-17-7 | CEP 2022-113 - Rev 01 | 2024-09-17 |
| Prilocaine | 721-50-6 | CEP 2024-300 - Rev 00 | 2025-12-19 |
| Ropivacaine Hydrochloride Monohydrate 罗哌卡因 | 132112-35-7 | CEP 2023-148 - Rev 01 | 2025-01-20 |
| Tadalafil 他达拉非 | 171596-29-5 | CEP 2025-131 - Rev 01 | 2026-02-19 |
| Tetracaine Hydrochloride 盐酸丁卡因 | 136-47-0 | CEP 2024-442 - Rev 00 | 2025-08-20 |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-09-11 06:00:12