浙江乐普药业股份有限公司
Zhejiang Lepu Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
40
40 products shown
🇺🇸 DMF
15
15 products shown
🇪🇺 CEP
7
7 products shown
Total
62
registrations
🇨🇳 CDE 注册 (40)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Anagliptin 那格列汀 | 739366-20-2 | Class I | Y20220000055 |
| Apixaban 阿哌沙班 | 503612-47-3 | Class A | Y20200000491 |
| Atorvastatin Calcium 阿托伐他汀钙 | 134523-00-5 | Class A | Y20190007449 |
| Betahistine 盐酸倍他司汀 | 5638-76-6 | Class A | Y20200001060 |
| Brivaracetam 布瓦西坦 | 357336-20-0 | Class I | Y20220000078 |
| Bromhexine 盐酸溴己新 | 3572-43-8 | Class A | Y20190004465 |
| Canagliflozin 卡格列净 | 842133-18-0 | Class A | Y20230001275 |
| Clopidogrel 氯吡格雷 | 113665-84-2 | Class A | Y20200001051 |
| Clopidogrel 氯吡格雷 | 113665-84-2 | Class A | Y20190001006 |
| Clopidogrel 氯吡格雷 | 113665-84-2 | Class A | Y20170002277 |
| Doxazosin 甲磺酸多沙唑嗪 | 74191-85-8 | Class A | Y20190007511 |
| Elagolix Sodium 艾拉戈克钠 | 834153-87-6 | Class I | Y20230000795 |
| Empagliflozin 恩格列净 | 864070-44-0 | Class A | Y20210000790 |
| Esomeprazole Sodium 埃索美拉唑镁 | 119141-88-7 | Class A | Y20170000384 |
| Fexofenadine 盐酸非索非那定 | 83799-24-0 | Class A | Y20190007452 |
| Finerenone HS236 | 1050477-31-0 | Class I | Y20250000132 |
| Fluvastatin Sodium 氟伐他汀钠 | 93957-54-1 | Class A | Y20230001392 |
| Fluvastatin Sodium 氟伐他汀钠 | 93957-54-1 | Class I | Y20230001125 |
| Itraconazole 伊曲康唑 | 84625-61-6 | Class A | Y20190007019 |
| Lansoprazole 兰索拉唑 | 103577-45-3 | Class A | Y20190007737 |
| Lenvatinib 甲磺酸仑伐替尼 | 417716-92-8 | Class A | Y20210000391 |
| Macitentan 马昔腾坦 | 441798-33-0 | Class A | Y20190000010 |
| Norfloxacin 诺氟沙星 | 70458-96-7 | Class A | Y20190007457 |
| Pamabrom 帕马溴 | 606-04-2 | Class A | Y20190007259 |
| Pazopanib 盐酸培唑帕尼 | 444731-52-6 | Class I | Y20250000951 |
| Rivaroxaban 利伐沙班 | 366789-02-8 | Class A | Y20210000022 |
| Rosuvastatin Calcium 瑞舒伐他汀钙 | 287714-41-4 | Class A | Y20210000578 |
| Selexipag 司来帕格 | 475086-01-2 | Class A | Y20230000520 |
| Sertraline 舍曲林 | 79617-96-2 | Class A | Y20190007454 |
| Sildenafil 枸橼酸西地那非 | - | Class I | Y20170000614 |
| Sitagliptin 西格列汀 | 486460-32-6 | Class A | Y20200001086 |
| Sodium Phenylbutyrate 苯丁酸钠 | 1716-12-7 | Class I | Y20170001102 |
| Tenofovir Disoproxil 酒石酸替诺福韦二吡呋酯 | 201341-05-1 | Class A | Y20170001084 |
| Thiamphenicol Glycinate Hydrochloride 盐酸甲砜霉素甘氨酸酯 | 15318-45-3 | Class A | Y20190003999 |
| Thymol 麝香草酚 | 89-83-8 | Class I | Y20240001056 |
| Ticagrelor 替格瑞洛 | 274693-27-5 | Class A | Y20190000753 |
| Tofacitinib 伊托法替布 | 477600-75-2 | Class A | Y20210000971 |
| Venlafaxine 文拉法辛 | - | Class A | Y20190003998 |
| Vortioxetine 氢溴酸伏硫西汀 | 508233-74-7 | Class I | Y20250000384 |
| Vortioxetine 氢溴酸伏硫西汀 | 508233-74-7 | Class A | Y20230001182 |
🇺🇸 DMF 注册 (15)
🇪🇺 CEP 注册 (7)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Atorvastatin Calcium 阿托伐他汀钙 | 134523-00-5 | R1-CEP 2012-139 - Rev 01 | - |
| Atorvastatin Calcium, Process 2 | 134523-03-8 | R0-CEP 2022-466 - Rev 00 | - |
| Clopidogrel Hydrogen Sulfate | 120202-66-6 | R0-CEP 2020-408 - Rev 00 | - |
| Clopidogrel Hydrogen Sulfate, Process II | 120202-66-6 | CEP 2024-001 - Rev 00 | - |
| Norfloxacin 诺氟沙星 | 70458-96-7 | CEP 2006-037 - Rev 05 | - |
| Rivaroxaban 利伐沙班 | 366789-02-8 | R0-CEP 2021-142 - Rev 00 | - |
| Rosuvastatin Calcium 瑞舒伐他汀钙 | 287714-41-4 | CEP 2020-243 - Rev 01 | - |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-04-09 07:23:01