浙江奥翔药业股份有限公司
Zhejiang Ausun Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
27
29 products shown
🇺🇸 DMF
24
24 products shown
🇪🇺 CEP
8
8 products shown
Total
59
registrations
🇨🇳 CDE 注册 (29)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| 贝美替尼 | - | Class I | Y20260000519 |
| Bicyclol 双环醇 | 118159-48-1 | Class A | Y20170000586 |
| Bimatoprost 贝美前列素 | 155206-00-1 | Class I | Y20250001251 |
| Dapagliflozin HS-10353 | 461432-26-8 | Class A | Y20240000835 |
| Entecavir 恩替卡伟 | 142217-69-4 | Class A | Y20170000439 |
| Febuxostat 非布司他 | 144060-53-7 | Class A | Y20190000927 |
| Fluvastatin Sodium 氟伐他汀钠 | 93957-54-1 | Class A | Y20240001245 |
| Galantamine 氢溴酸加兰他敏 | 357-70-0 | Class I | Y20260000687 |
| Ibrutinib 伊布替尼 | 936563-96-1 | Class I | Y20260000087 |
| Ibrutinib 伊布替尼 | 936563-96-1 | Class I | Y20250001309 |
| Imatinib 硫酸艾玛昔替尼 | 152459-95-5 | Class A | Y20230001105 |
| Lenvatinib 甲磺酸仑伐替尼 | 417716-92-8 | Class A | Y20240001119 |
| Lumateperone 甲苯磺酸卢美哌隆 | 313368-91-1 | Class I | Y20240001117 |
| Macitentan 马昔腾坦 | 441798-33-0 | Class A | Y20220001020 |
| Miglitol 米格列醇 | 72432-03-2 | Class A | Y20240000644 |
| Miglitol 米格列醇 | 72432-03-2 | Class A | Y20170001242 |
| Nebivolol 盐酸奈必洛尔 | 118457-14-0 | Class I | Y20230000174 |
| Olaparib 奥拉帕利 | 763113-22-0 | Class I | Y20250000734 |
| Osimertinib Mesylate 甲磺酸奥希替尼 | 1421373-66-1 | Class I | Y20260000324 |
| Palbociclib 帕博西尼 | 571190-30-2 | Class A | Y20240000519 |
| Pilocarpine 盐酸毛果芸香碱 | 92-13-7 | Class I | Y20240000995 |
| Posaconazole 泊沙康唑 | 171228-49-2 | Class A | Y20180001585 |
| Ramelteon 雷美替胺 | 196597-26-9 | Class I | Y20230001318 |
| Ruxolitinib 磷酸芦可替尼 | 941678-49-5 | Class A | Y20240001130 |
| Sitafloxacin 西他沙星 | 127254-12-0 | Class A | Y20200000899 |
| Sugammadex Sodium 舒更葡糖钠 | 343306-71-8 | Class A | Y20200000429 |
| Tafluprost 他氟前列素 | 209860-87-7 | Class A | Y20220000747 |
| Tofacitinib 伊托法替布 | 477600-75-2 | Class A | Y20210000144 |
| Trametinib 曲美替尼 | 871700-17-3 | Class I | Y20250001460 |
🇺🇸 DMF 注册 (24)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Avatrombopag Maleate Polymorphic Form B | 677007-74-8 | 41803 | 2025-04-30 |
| Avatrombopag Maleate Polymorphic Form C 阿伐曲泊帕 马来酸盐 | 677007-74-8 | 41921 | 2025-05-15 |
| Efinaconazole 艾氟康唑 | 164650-44-6 | 32076 | 2017-11-06 |
| Entecavir Monohydrate Bulk Drug Substance | 209216-23-9 | 25200 | 2011-08-05 |
| Febuxostat Hemihydrate 非布司他 | 442664-09-7 | 29716 | 2015-09-22 |
| Latanoprost 拉坦前列素 | 130209-82-4 | 41866 | 2025-06-28 |
| Lenvatinib Besylate 苯磺酸甲磺酸仑伐替尼 | 2414382-25-3 | 42077 | 2025-08-07 |
| Lubiprostone 芦比前列酮 | 333963-40-9 | 30802 | 2016-08-08 |
| Lumateperone Tosylate 甲苯磺酸卢美哌隆 | 1187020-80-9 | 42658 | 2025-10-02 |
| Macitentan 马昔腾坦 | 441798-33-0 | 41152 | 2025-04-29 |
| Maralixibat Chloride 马立昔巴特 | 228113-66-4 | 41496 | 2025-03-27 |
| Nebivolol Hydrochloride 盐酸奈必洛尔 | 152520-56-4 | 29730 | 2015-09-28 |
| Olaparib 奥拉帕利 | 763113-22-0 | 41845 | 2025-04-30 |
| Palbociclib 帕博西尼 | 571190-30-2 | 40807 | 2024-11-29 |
| Pilocarpine Hydrochloride 盐酸毛果芸香碱 | 54-71-7 | 38901 | 2023-09-30 |
| Posaconazole 泊沙康唑 | 171228-49-2 | 29731 | 2016-02-10 |
| Ramelteon 雷美替胺 | 196597-26-9 | 33719 | 2019-08-31 |
| Ruxolitinib Phosphate 磷酸芦可替尼 | 1092939-17-7 | 42119 | 2025-06-30 |
| Sitafloxacin Hydrate 西他沙星 | 163253-35-8 | 40808 | 2024-12-09 |
| Sugammadex Sodium 舒更葡糖钠 | 343306-71-8 | 35151 | 2020-09-29 |
| Tafluprost 他氟前列素 | 209860-87-7 | 39505 | 2024-02-06 |
| Tasimelteon 他司美琼 | 609799-22-6 | 32077 | 2017-11-07 |
| Tofacitinib Citrate 枸橼酸伊托法替布 | 540737-29-9 | 35152 | 2020-09-29 |
| Travoprost 曲伏前列素 | 157283-68-6 | 40018 | 2024-05-30 |
🇪🇺 CEP 注册 (8)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Entecavir Monohydrate 恩替卡伟 | 209216-23-9 | R1-CEP 2016-152 - Rev 00 | 2022-06-27 |
| Entecavir Monohydrate, Process Czk | 209216-23-9 | CEP 2023-239 - Rev 00 | 2024-12-11 |
| Imatinib Mesilate, Form-β | 220127-57-1 | CEP 2023-303 - Rev 01 | 2025-11-12 |
| Latanoprost 拉坦前列素 | 130209-82-4 | CEP 2022-174 - Rev 00 | 2023-10-23 |
| Nebivolol Hydrochloride 盐酸奈必洛尔 | 152520-56-4 | R0-CEP 2022-170 - Rev 00 | 2022-12-09 |
| Pilocarpine Hydrochloride 盐酸毛果芸香碱 | 54-71-7 | CEP 2023-367 - Rev 00 | 2025-04-02 |
| Ticagrelor 替格瑞洛 | 274693-27-5 | R0-CEP 2021-081 - Rev 00 | 2022-08-10 |
| Ticagrelor, Polymorphic Form II (process A) 替格瑞洛 | 274693-27-5 | CEP 2025-604 - Rev 00 | 2026-03-23 |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-09-11 06:00:12