四川科伦药业股份有限公司
Sichuan Kelun Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
79
79 products shown
🇺🇸 DMF
17
17 products shown
🇪🇺 CEP
1
1 products shown
Total
97
registrations
🇨🇳 CDE 注册 (79)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Alanyl Glutamine N(2)-L-丙氨酰-L-谷氨酰胺 | 39537-23-0 | Class A | Y20190008954 |
| Amoxicillin Sodium 阿莫西林钠 | 26787-78-0 | Class A | Y20190008892 |
| Apalutamide 阿帕他胺 | 956104-40-8 | Class A | Y20220001255 |
| Aprepitant 阿瑞匹坦 | 170729-80-3 | Class A | Y20220001106 |
| Atosiban 醋酸阿托西班 | 90779-69-4 | Class A | Y20240000529 |
| Avatrombopag 马来酸阿伐曲泊帕 | 570406-98-3 | Class A | Y20220001097 |
| Baclofen 巴氯芬 | 1134-47-0 | Class I | Y20170000669 |
| Brexpiprazole 布瑞哌唑 | 913611-97-9 | Class A | Y20220000975 |
| Brivaracetam 布瓦西坦 | 357336-20-0 | Class I | Y20240000811 |
| Bupivacaine Hydrochloride 布比卡因 | - | Class A | Y20220000764 |
| Canagliflozin 卡格列净 | 842133-18-0 | Class A | Y20200000093 |
| Celecoxib 塞来昔布 | 169590-42-5 | Class A | Y20190021398 |
| Cisatracurium Besilate 苯磺顺阿曲库铵 | 96946-41-7 | Class A | Y20200001414 |
| Citalopram 西酞普兰 | 59729-33-8 | Class A | Y20190008955 |
| Clevidipine 氯维地平 | 167221-71-8 | Class A | Y20220001166 |
| Colloidal Bismuth Pectin 胶体果胶铋 | 9000-69-5 | Class A | Y20190008855 |
| Dacomitinib 达可替尼 | 1110813-31-4 | Class A | Y20220001095 |
| Dapoxetine 盐酸达泊西汀 | 119356-77-3 | Class A | Y20180000136 |
| Edetate Calcium Disodium 依地酸钙钠 | 62-33-9 | Class A | Y20190008956 |
| Eldercalcitol 艾地骨化醇 | - | Class A | Y20230000297 |
| Eltrombopag Olamine 艾曲泊帕乙醇胺 | 496775-61-2 | Class A | Y20210000057 |
| Empagliflozin 恩格列净 | 864070-44-0 | Class A | Y20180001382 |
| Enzalutamide 氘恩扎鲁胺 | 915087-33-1 | Class A | Y20230001008 |
| Erlotinib 盐酸厄洛替尼 | 183321-74-6 | Class A | Y20190021483 |
| Escitalopram Oxalate 草酸艾司西酞普兰 | 59729-33-8 | Class A | Y20190008922 |
| Finerenone HS236 | 1050477-31-0 | Class I | Y20250000371 |
| Gadobenate Dimeglumine 钆贝葡胺 | 127000-20-8 | Class I | Y20250001147 |
| Gimeracil 吉美嘧啶 | 103766-25-2 | Class A | Y20220000807 |
| Ibrutinib 伊布替尼 | 936563-96-1 | Class A | Y20240000254 |
| Iguratimod 艾拉莫德 | 123663-49-0 | Class A | Y20240000983 |
| Ilaprazole 艾普拉唑 | 172152-36-2 | Class I | Y20250000807 |
| Iomeprol 碘美普尔 | 78649-41-9 | Class I | Y20230001149 |
| Isavuconazole 硫酸艾沙康唑 | 241479-67-4 | Class A | Y20230000518 |
| Ixazomib 枸橼酸伊沙佐米 | 1239908-20-3 | Class A | Y20230000110 |
| Levornidazole 磷酸左奥硝唑酯二钠 | 16773-42-5 | Class I | Y20250001307 |
| Ligustrazine Hydrochloride 盐酸尼非卡兰 | 7647-01-0 | Class A | Y20170001515 |
| Linezolid 利奈唑胺 | 165800-03-3 | Class A | Y20190021414 |
| Lumretuzumab 富马酸仑博替尼 | - | Class I | Y20250000853 |
| Lusutrombopag 芦曲泊帕 | 1110766-97-6 | Class A | Y20230000612 |
| Methylene Blue 亚甲蓝 | 61-73-4 | Class I | Y20250001201 |
| Mianserin 盐酸米安色林 | 24219-97-4 | Class I | Y20250001350 |
| Mirogabalin 苯磺酸美洛加巴林 | 1138245-13-2 | Class I | Y20250000830 |
| Mivacurium Chloride 米库氯铵 | 106861-44-3 | Class I | Y20240001048 |
| Nafamostat 甲磺酸萘莫司他 | 82956-11-4 | Class A | Y20240000248 |
| Nalfurafine 盐酸纳呋拉啡 | 152657-84-6 | Class A | Y20230001277 |
| Neratinib 马来酸奈拉替尼 | 698387-09-6 | Class A | Y20220000498 |
| Neratinib 马来酸奈拉替尼 | 698387-09-6 | Class A | Y20210000541 |
| Netupitant 奈妥匹坦 | 290297-26-6 | Class A | Y20220000763 |
| Nintedanib Ethanesulfonate 乙磺酸尼达尼布 | 656247-18-6 | Class A | Y20210000162 |
| Obeticholic Acid 奥贝胆酸 | 459789-99-2 | Class I | Y20210000692 |
| Olaparib 奥拉帕利 | 763113-22-0 | Class A | Y20220000006 |
| Olmesartan Medoxomil 奥美沙坦酯 | 144689-63-4 | Class I | Y20170001117 |
| Omadacycline 甲苯磺酸奥马环素 | 389139-89-3 | Class I | Y20250000446 |
| Omeprazole 奥美拉唑 | 73590-58-6 | Class A | Y20190008854 |
| Pazufloxacin 甲磺酸帕珠沙星 | 127045-41-4 | Class A | Y20190008663 |
| Pemafibrate 佩玛贝特 | 848259-27-8 | Class I | Y20230000301 |
| Posaconazole 泊沙康唑 | 171228-49-2 | Class A | Y20200001230 |
| Potassium Oxonate 奥替拉西钾 | 2207-75-2 | Class A | Y20220000806 |
| Prulifloxacin 普卢利沙星 | 123447-62-1 | Class A | Y20190008857 |
| Regorafenib 瑞戈非尼 | 755037-03-7 | Class A | Y20210000809 |
| Revefenacin 雷芬那辛 | 864750-70-9 | Class I | Y20240000001 |
| Roxadustat 罗沙司他 | 808118-40-3 | Class A | Y20220000992 |
| Ruxolitinib 磷酸芦可替尼 | 941678-49-5 | Class I | Y20250000039 |
| Sacubitril/valsartan Sodium 沙库巴曲缬沙坦钠 | 137862-53-4 | Class A | Y20210000407 |
| Sildenafil 枸橼酸西地那非 | - | Class A | Y20190021415 |
| Siponimod 西尼莫德 | 1230487-00-9 | Class A | Y20220001165 |
| Sodium Glycerophosphate 甘油磷酸钠 | 55073-41-1 | Class A | Y20230000484 |
| Sodium Pantothenate 泛酸钠 | 79-83-4 | Class A | Y20190008665 |
| Sorafenib 甲苯磺酸索拉非尼 | 284461-73-0 | Class A | Y20210000914 |
| Sugammadex Sodium 舒更葡糖钠 | 343306-71-8 | Class A | Y20180001443 |
| Tenofovir Alafenamide 富马酸丙酚替诺福韦 | 379270-37-8 | Class A | Y20190000242 |
| Terbutaline 硫酸特布他林 | 56829-85-1 | Class A | Y20210000543 |
| Tofacitinib 伊托法替布 | 477600-75-2 | Class A | Y20180000139 |
| Trelagliptin 琥珀酸曲格列汀 | 1029877-94-8 | Class A | Y20200000773 |
| Trifluridine, Combinations 曲氟尿苷 | - | Class A | Y20220000075 |
| Trifluridine, Combinations 曲氟尿苷 | - | Class I | Y20210001194 |
| Valaciclovir 盐酸伐昔洛韦 | 124832-26-4 | Class A | Y20190008661 |
| Vardenafil Hydrochloride 盐酸伐地那非三水合物 | 224785-90-4 | Class A | Y20180000752 |
| Vonoprazan 富马酸伏诺拉生 | 881681-00-1 | Class A | Y20210000854 |
🇺🇸 DMF 注册 (17)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Apalutamide 阿帕他胺 | 956104-40-8 | - | 2024-05-05 |
| Aprepitant 阿瑞匹坦 | 170729-80-3 | - | 2018-09-16 |
| Empagliflozin 恩格列净 | 864070-44-0 | - | 2017-12-29 |
| Enzalutamide 氘恩扎鲁胺 | 915087-33-1 | - | 2020-06-24 |
| Finerenone HS236 | 1050477-31-0 | - | 2024-10-29 |
| Ibrutinib 伊布替尼 | 936563-96-1 | - | 2017-05-05 |
| Neratinib Maleate 马来酸奈拉替尼 | 915942-22-2 | - | 2022-08-29 |
| Netupitant 奈妥匹坦 | 290297-26-6 | - | 2025-12-29 |
| Nintedanib Esylate 乙磺酸尼达尼布 | 656247-18-6 | - | 2018-04-02 |
| Olaparib 奥拉帕利 | 763113-22-0 | - | 2025-04-30 |
| Omadacycline Tosylate 甲苯磺酸奥马环素 | 1075240-43-5 | - | 2025-03-26 |
| Pemafibrate 佩玛贝特 | 848259-27-8 | - | 2025-06-17 |
| Posaconazole 泊沙康唑 | 171228-49-2 | - | 2016-02-10 |
| Regorafenib 瑞戈非尼 | 755037-03-7 | - | 2024-04-27 |
| Sacubitril Valsartan Sodium 沙库巴曲缬沙坦钠 | 1898188-76-5 | - | 2024-07-12 |
| Sildenafil Citrate 枸橼酸西地那非 | 171599-83-0 | - | 2004-10-25 |
| Siponimod 西尼莫德 | 1230487-00-9 | - | 2025-05-22 |
🇪🇺 CEP 注册 (1)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Sildenafil Citrate 枸橼酸西地那非 | 171599-83-0 | R0-CEP 2022-490 - Rev 00 | - |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-04-09 07:23:01