浙江天宇药业股份有限公司
Zhejiang Tianyu Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
35
35 products shown
🇺🇸 DMF
15
15 products shown
🇪🇺 CEP
18
18 products shown
Total
68
registrations
🇨🇳 CDE 注册 (35)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Apixaban 阿哌沙班 | 503612-47-3 | Class A | Y20200000025 |
| Avatrombopag 马来酸阿伐曲泊帕 | 570406-98-3 | Class A | Y20230000333 |
| Azilsartan Medoxomil 阿齐沙坦 | 863031-21-4 | Class A | Y20220000914 |
| Azilsartan Medoxomil 阿齐沙坦 | 863031-21-4 | Class A | Y20170001664 |
| Azilsartan Medoxomil Potassium MY008211A | 863031-21-4 | Class I | Y20240001145 |
| Brivaracetam 布瓦西坦 | 357336-20-0 | Class I | Y20240000776 |
| Candesartan Cilexetil 坎地沙坦酯 | 139481-59-7 | Class A | Y20190008803 |
| Dabigatran Etexilate 达比加群酯 | 211915-06-9 | Class A | Y20220000053 |
| Dapagliflozin HS-10353 | 461432-26-8 | Class A | Y20220001121 |
| Empagliflozin 恩格列净 | 864070-44-0 | Class A | Y20220000965 |
| Ezetimibe 依折麦布 | 163222-33-1 | Class I | Y20250000915 |
| Ezetimibe 依折麦布 | 163222-33-1 | Class A | Y20190000721 |
| Febuxostat 非布司他 | 144060-53-7 | Class A | Y20200000913 |
| Henggegliflozin Proline 脯氨酸恒格列净 | 5519-60-8 | Class A | Y20200000647 |
| Imrecoxib 艾瑞昔布 | 395683-14-4 | Class A | Y20190001037 |
| Irbesartan 厄贝沙坦 | 138402-11-6 | Class A | Y20190009706 |
| Irbesartan 厄贝沙坦 | 138402-11-6 | Class I | Y20180000158 |
| Losartan Potassium 氯沙坦钾 | 114798-26-4 | Class A | Y20190008907 |
| Montelukast Sodium 孟鲁司特钠 | 158966-92-8 | Class A | Y20190009826 |
| Montelukast Sodium 孟鲁司特钠 | 158966-92-8 | Class A | Y20190000083 |
| Nicorandil 尼可地尔(注射级) | 65141-46-0 | Class A | Y20220000959 |
| Olmesartan Medoxomil 奥美沙坦酯 | 144689-63-4 | Class A | Y20170000035 |
| Oteseconazole 奥特康唑 | 1340593-59-0 | Class A | Y20230000624 |
| Pregabalin 普瑞巴林 | 148553-50-8 | Class A | Y20180001381 |
| Rivaroxaban 利伐沙班 | 366789-02-8 | Class A | Y20200001006 |
| Sacubitril/valsartan Sodium 沙库巴曲缬沙坦钠 | 137862-53-4 | Class A | Y20220000721 |
| Silodosin 赛洛多辛 | 160970-54-7 | Class A | Y20200000509 |
| Sitagliptin 西格列汀 | 486460-32-6 | Class A | Y20190021346 |
| Tafluprost 他氟前列素 | 209860-87-7 | Class A | Y20190000507 |
| Telmisartan 替米沙坦 | 144701-48-4 | Class I | Y20170000342 |
| Ticagrelor 替格瑞洛 | 274693-27-5 | Class A | Y20170002223 |
| Valsartan 缬沙坦 | 137862-53-4 | Class A | Y20210000953 |
| Valsartan 缬沙坦 | 137862-53-4 | Class A | Y20190009705 |
| Valsartan 缬沙坦 | 137862-53-4 | Class A | Y20170002209 |
| Vildagliptin 维格列汀 | 274901-16-5 | Class A | Y20190021405 |
🇺🇸 DMF 注册 (15)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Cabozantinib (s)-malate 卡博替尼 | 1140909-48-3 | - | 2025-09-25 |
| Edoxaban Tosilate 依度沙班 | 480449-71-6 | - | 2024-12-30 |
| Ezetimibe 依折麦布 | 163222-33-1 | - | 2021-09-22 |
| Losartan Potassium 氯沙坦钾 | 114798-26-4 | - | 2011-12-20 |
| Losartan Potassium (l-3) 氯沙坦钾 | 124750-99-8 | - | 2021-08-21 |
| Methyl N-[(2'-cyanobiphenyl-4-yl)methyl]-l-valinate Hydrochloride | - | - | 2019-07-17 |
| Montelukast Backone Diol | - | - | 2012-05-26 |
| Montelukast Sodium 孟鲁司特钠 | 158966-92-8 | - | 2018-03-24 |
| Olmesartan Medoxomil 奥美沙坦酯 | 144689-63-4 | - | 2018-02-09 |
| Rivaroxaban 利伐沙班 | 366789-02-8 | - | 2015-05-18 |
| Sacubitril Sodium 沙库巴曲钠 | 149690-05-1 | - | 2018-12-31 |
| Sacubitril Sodium (process Ii) | 149690-05-1 | - | 2025-09-30 |
| Telmisartan Methyl Ester 替米沙坦 | 528560-93-2 | - | 2011-11-09 |
| Valsartan 缬沙坦 | 137862-53-4 | - | 2012-03-01 |
| Valsartan Disodium 缬沙坦二钠 | 137862-53-4 | - | 2018-12-30 |
🇪🇺 CEP 注册 (18)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Brivaracetam 布瓦西坦 | 357336-20-0 | CEP 2025-089 - Rev 00 | - |
| Candesartan Cilexetil 坎地沙坦酯 | 139481-59-7 | CEP 2013-256 - Rev 03 | - |
| Dabigatran Etexilate Mesilate, Micronised, Non-micronised | 872728-81-9 | CEP 2024-073 - Rev 02 | - |
| Irbesartan 厄贝沙坦 | 138402-11-6 | CEP 2012-233 - Rev 03 | - |
| Irbesartan, Process II 厄贝沙坦颗粒 | 138402-11-6 | CEP 2025-025 - Rev 00 | - |
| Losartan Potassium 氯沙坦钾 | 114798-26-4 | CEP 2009-227 - Rev 07 | - |
| Losartan Potassium, Process-iii | 124750-99-8 | R0-CEP 2021-320 - Rev 00 | - |
| Montelukast Sodium 孟鲁司特钠 | 158966-92-8 | R1-CEP 2014-115 - Rev 01 | - |
| Nicorandil 尼可地尔(注射级) | 65141-46-0 | CEP 2023-426 - Rev 00 | - |
| Olmesartan Medoxomil 奥美沙坦酯 | 144689-63-4 | CEP 2013-268 - Rev 03 | - |
| Olmesartan Medoxomil, Process II 奥美沙坦酯 | 144689-63-4 | R0-CEP 2022-058 - Rev 00 | - |
| Rivaroxaban 利伐沙班 | 366789-02-8 | R0-CEP 2020-330 - Rev 01 | - |
| Sitagliptin Phosphate Monohydrate | 654671-77-9 | CEP 2020-037 - Rev 02 | - |
| Telmisartan 替米沙坦 | 144701-48-4 | R1-CEP 2014-190 - Rev 00 | - |
| Telmisartan, Process II 替米沙坦 | 144701-48-4 | CEP 2025-215 - Rev 00 | - |
| Ticagrelor 替格瑞洛 | 274693-27-5 | R0-CEP 2021-348 - Rev 00 | - |
| Valsartan 缬沙坦 | 137862-53-4 | R1-CEP 2013-159 - Rev 02 | - |
| Valsartan, Process-ii 缬沙坦二钠 | 137862-53-4 | CEP 2020-389 - Rev 04 | - |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-04-09 07:23:01