山东科源制药股份有限公司
Shandong Keyuan Pharmaceutical Co. Ltd. Jinan Cn
Country: CN CDE+DMF+CEP MEDIUM
🇨🇳 CDE
33
33 products shown
🇺🇸 DMF
3
3 products shown
🇪🇺 CEP
3
3 products shown
Total
39
registrations
🇨🇳 CDE 注册 (33)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Amlexanox 氨来呫诺 | 68302-57-8 | Class A | Y20190008795 |
| Chlorzoxazone 氯唑沙宗 | 95-25-0 | Class A | Y20190007706 |
| Clarithromycin 克拉霉素 | 81103-11-9 | Class A | Y20190008794 |
| Clemastine 富马酸氯马斯汀 | 15686-51-8 | Class A | Y20210000263 |
| Clemastine 富马酸氯马斯汀 | 15686-51-8 | Class A | Y20190008393 |
| Diclofenac Potassium 双氯芬酸钾 | 15307-86-5 | Class A | Y20190001590 |
| Edaravone 依达拉奉 | 89-25-8 | Class A | Y20170000092 |
| Esmolol 盐酸艾司洛尔 | 81147-92-4 | Class A | Y20190008385 |
| Esomeprazole Sodium 埃索美拉唑镁 | 119141-88-7 | Class A | Y20170001365 |
| Etamsylate 酚磺乙胺 | 2624-44-4 | Class A | Y20200000295 |
| Fluoxetine 盐酸氟西汀 | 54910-89-3 | Class A | Y20190008906 |
| Gliclazide 格列齐特 | 21187-98-4 | Class A | Y20190008391 |
| Isoprenaline 盐酸异丙肾上腺素 | 7683-59-2 | Class A | Y20190008387 |
| Isosorbide Dinitrate 硝酸异山梨酯 | 87-33-2 | Class A | Y20190008392 |
| Isosorbide Mononitrate 单硝酸异山梨酯 | 16051-77-7 | Class A | Y20190008394 |
| Lansoprazole 兰索拉唑 | 103577-45-3 | Class A | Y20190008916 |
| Lurasidone 盐酸鲁拉西酮 | 367514-87-2 | Class A | Y20230000055 |
| Mecobalamin 甲钴胺 | 13422-55-4 | Class A | Y20190008797 |
| Metformin 二甲双胍 | 657-24-9 | Class A | Y20190009395 |
| Metformin 二甲双胍 | 657-24-9 | Class A | Y20180000016 |
| Nisoldipine 尼索地平 | 63675-72-9 | Class A | Y20190008395 |
| Palonosetron 盐酸帕洛诺司琼 | 135729-61-2 | Class A | Y20170000795 |
| Parecoxib Sodium 帕瑞昔布钠 | 198470-84-7 | Class A | Y20200000867 |
| Phenylbutazone 保泰松 | 50-33-9 | Class I | Y20240001223 |
| Pranoprofen 普拉洛芬 | 52549-17-4 | Class A | Y20200000884 |
| Propafenone 盐酸普罗帕酮 | 54063-53-5 | Class A | Y20190001553 |
| Ropivacaine 盐酸罗哌卡因 | 84057-95-4 | Class A | Y20190008796 |
| Rotigotine 罗替戈汀 | 99755-59-6 | Class I | Y20240001227 |
| Sacubitril/valsartan Sodium 沙库巴曲缬沙坦钠 | 137862-53-4 | Class I | Y20250000880 |
| Trepibutone 曲匹布通 | 41826-92-0 | Class A | Y20190007701 |
| Vildagliptin 维格列汀 | 274901-16-5 | Class A | Y20200001448 |
| Vitamin A 维生素A棕榈酸酯（BHA,BHT） | 79-81-2 | Class I | Y20250001273 |
| Xantinol Nicotinate 烟酸占替诺 | 437-74-1 | Class A | Y20190008386 |
🇺🇸 DMF 注册 (3)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Diluted Isosorbide Mononitrate (drug Substance, Non-sterile) 单硝酸异山梨酯70%，乳糖稀释 | 16051-77-7 | - | 2008-06-18 |
| Metformin Hydrochloride 盐酸二甲双胍 + 0.5%硬脂酸镁 | 657-24-9 | - | 2002-11-25 |
| Resmetirom Intermediate: 6-(4-amino-2,6-dichlorophenoxy)-4-isopropylpyridazin-3(2h)-one | 920509-28-0 | - | 2025-01-13 |
🇪🇺 CEP 注册 (3)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Gliclazide 格列齐特 | 21187-98-4 | R1-CEP 2006-007 - Rev 01 | - |
| Isosorbide Mononitrate, Diluted, 80%, 40%, 25% And 20% In Lactose 单硝酸异山梨酯70%，乳糖稀释 | 16051-77-7 | CEP 2008-112 - Rev 01 | - |
| Metformin Hydrochloride 盐酸二甲双胍 + 0.5%硬脂酸镁 | 657-24-9 | R0-CEP 2019-288 - Rev 00 | - |
Source: ema_cep;FDA_DMF | Updated: 2026-04-09 07:23:02