山东新华制药股份有限公司
Shandong Xinhua Pharmaceutical Company Limited
Country: CN CDE+DMF MEDIUM
🇨🇳 CDE
87
87 products shown
🇺🇸 DMF
2
2 products shown
🇪🇺 CEP
0
0 products shown
Total
89
registrations
🇨🇳 CDE 注册 (87)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Alogliptin Benzoate 苯甲酸阿格列汀 | 850649-61-5 | Class A | Y20210001145 |
| Aminophenazone 氨基比林 | 58-15-1 | Class A | Y20190009433 |
| Aminophenazone 氨基比林 | 58-15-1 | Class I | Y20190000138 |
| Aminophylline 氨茶碱 | 317-34-0 | Class A | Y20190007733 |
| Amlodipine 氨氯地平 | 88150-42-9 | Class A | Y20170000237 |
| Amobarbital 异戊巴比妥 | 57-43-2 | Class A | Y20190009432 |
| Amobarbital 异戊巴比妥 | 57-43-2 | Class I | Y20190000602 |
| Apixaban 阿哌沙班 | 503612-47-3 | Class A | Y20200000748 |
| Aspirin 阿司匹林 | 50-78-2 | Class A | Y20190009431 |
| Aspirin 阿司匹林 | 50-78-2 | Class I | Y20180001326 |
| Atorvastatin Calcium 阿托伐他汀钙 | 134523-00-5 | Class A | Y20170000660 |
| Barbital 格鲁米特 | 57-44-3 | Class A | Y20190009437 |
| Barbital 格鲁米特 | 57-44-3 | Class I | Y20190000149 |
| Benserazide 盐酸苄丝肼 | - | Class I | Y20240000681 |
| Caffeine 咖啡因 | 58-08-2 | Class A | Y20190009426 |
| Caffeine 咖啡因 | 58-08-2 | Class I | Y20180001389 |
| Calcium Gluconate 葡萄糖酸钙 | 299-28-5 | Class A | Y20210000840 |
| Carbidopa 卡比多巴 | 28860-95-9 | Class A | Y20200000351 |
| Clarithromycin 克拉霉素 | 81103-11-9 | Class A | Y20190003671 |
| Clindamycin 克林霉素 | - | Class A | Y20190007927 |
| Cortisone 醋酸可的松 | 50-04-4 | Class I | Y20250001500 |
| Dexibuprofen 右旋布洛芬 | 51146-56-6 | Class A | Y20190009435 |
| Dexibuprofen 右旋布洛芬 | 51146-56-6 | Class A | Y20180001074 |
| Doxofylline 多索茶碱 | 69975-86-6 | Class A | Y20190009436 |
| Doxofylline 多索茶碱 | 69975-86-6 | Class I | Y20180001434 |
| Edaravone 依达拉奉 | 89-25-8 | Class A | Y20170000745 |
| Eicosapentaenoic Acid Ethyl Ester 二十碳五烯酸乙酯 | 86227-47-6 | Class A | Y20230000457 |
| Eicosapentaenoic Acid Ethyl Ester 二十碳五烯酸乙酯 | 86227-47-6 | Class I | Y20210001073 |
| Enoxacin 葡萄糖酸依诺沙星 | 74011-58-8 | Class A | Y20190001821 |
| Entacapone 恩他卡朋 | 130929-57-6 | Class I | Y20250000995 |
| Escitalopram Oxalate 草酸艾司西酞普兰 | 59729-33-8 | Class A | Y20170001449 |
| Esomeprazole Magnesium 埃索美拉唑镁 | 119141-88-7 | Class A | Y20220001327 |
| Etofesalamide 乙氧苯柳胺 | 64700-55-6 | Class A | Y20190001805 |
| Fasudil 盐酸法舒地尔 | 103745-39-7 | Class A | Y20170000376 |
| Febuxostat 非布司他 | 144060-53-7 | Class A | Y20210001232 |
| Glimepiride 格列美脲 | 93479-97-1 | Class A | Y20190008433 |
| Hydrocortisone 氢化可的松（工艺Ⅱ） | 50-23-7 | Class I | Y20250001403 |
| Hydrocortisone 氢化可的松（工艺Ⅱ） | 50-23-7 | Class A | Y20190009427 |
| Hydrocortisone 氢化可的松（工艺Ⅱ） | 50-23-7 | Class I | Y20190000619 |
| Hydrocortisone 氢化可的松（工艺Ⅱ） | 50-23-7 | Class I | Y20170001890 |
| Ibuprofen 精氨酸布洛芬 | 58560-75-1 | Class A | Y20230001014 |
| Irisquinone 马蔺子素 | 56495-82-0 | Class A | Y20190001803 |
| Lactic Acid (S)-乳酸 | 50-21-5 | Class A | Y20190003685 |
| Levodopa 多巴丝肼颗粒 | 59-92-7 | Class A | Y20190009756 |
| Levodopa 多巴丝肼颗粒 | 59-92-7 | Class A | Y20190000053 |
| Levodopa 多巴丝肼颗粒 | 59-92-7 | Class I | Y20180000897 |
| Meloxicam 美洛昔康 | 71125-38-7 | Class A | Y20190009424 |
| Meloxicam 美洛昔康 | 71125-38-7 | Class A | Y20190000328 |
| Meprednisone 泼尼松 | 1247-42-3 | Class A | Y20220000275 |
| Metamizole 安乃近 | 68-89-3 | Class A | Y20190009430 |
| Metamizole 安乃近 | 68-89-3 | Class A | Y20190009429 |
| Metamizole 安乃近 | 68-89-3 | Class I | Y20180001391 |
| Moxifloxacin 盐酸莫西沙星 | 151096-09-2 | Class I | Y20170000961 |
| Naloxone 盐酸纳洛酮 | 465-65-6 | Class A | Y20190001802 |
| Nevirapine 奈韦拉平 | 129618-40-2 | Class A | Y20190001809 |
| Nimodipine 尼莫地平（预制颗粒） | 66085-59-4 | Class A | Y20190009425 |
| Nimodipine 尼莫地平（预制颗粒） | 66085-59-4 | Class I | Y20180001435 |
| Nisoldipine 尼索地平 | 63675-72-9 | Class A | Y20190003686 |
| Omega-3 Fatty Acid Ethyl Esters 90 ω-3脂肪酸乙酯90 | 103368-22-5 | Class I | Y20250001501 |
| Oxiracetam 奥拉西坦 | 62613-82-5 | Class I | Y20170001291 |
| Pazufloxacin 甲磺酸帕珠沙星 | 127045-41-4 | Class A | Y20190006413 |
| Pentazocine 喷他佐辛 | 359-83-1 | Class A | Y20220001328 |
| Phenazone 安替比林 | 60-80-0 | Class A | Y20190009428 |
| Phenazone 安替比林 | 60-80-0 | Class I | Y20180001390 |
| Phenobarbital 苯巴比妥 | 50-06-6 | Class A | Y20190009361 |
| Phenobarbital 苯巴比妥 | 50-06-6 | Class I | Y20180001052 |
| Pipemidic Acid 吡哌酸 | 51940-44-4 | Class A | Y20190009434 |
| Pipemidic Acid 吡哌酸 | 51940-44-4 | Class I | Y20180001694 |
| Polycarbophil 聚卡波非钙 | 10125-98-1 | Class A | Y20190009887 |
| Polycarbophil 聚卡波非钙 | 10125-98-1 | Class I | Y20180000981 |
| Prednisolone 盐酸赖氨酸 | 50-24-8 | Class A | Y20230001352 |
| Prednisolone 盐酸赖氨酸 | 50-24-8 | Class A | Y20200000903 |
| Prednisone Acetate 醋酸泼尼松 | 1247-42-3 | Class A | Y20190001819 |
| Propyphenazone 异丙安替比林 | 479-92-5 | Class A | Y20190009423 |
| Propyphenazone 异丙安替比林 | 479-92-5 | Class I | Y20190000483 |
| Rabeprazole Sodium 雷贝拉唑钠 | 117976-89-3 | Class A | Y20190009852 |
| Rabeprazole Sodium 雷贝拉唑钠 | 117976-89-3 | Class A | Y20170001889 |
| Sacubitril/valsartan Sodium 沙库巴曲缬沙坦钠 | 137862-53-4 | Class A | Y20230000980 |
| Salicylic Acid 水杨酸 | 69-72-7 | Class A | Y20190001815 |
| Sevelamer 碳酸司维拉姆 | - | Class A | Y20210000306 |
| Sodium Stibogluconate 葡萄糖酸锑钠 | - | Class A | Y20190001816 |
| Sulfacetamide 乙酰胺 | 144-80-9 | Class A | Y20200001357 |
| Tofacitinib 伊托法替布 | 477600-75-2 | Class I | Y20250000704 |
| Tramadol 盐酸曲马多 | 27203-92-5 | Class A | Y20190001792 |
| Tribendimidine 三苯双脒 | 115103-15-6 | Class A | Y20190001796 |
| Trimethoprim 甲氧苄啶 | 738-70-5 | Class A | Y20190001817 |
| Vonoprazan 富马酸伏诺拉生 | 881681-00-1 | Class A | Y20230001353 |
🇺🇸 DMF 注册 (2)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Facility And Procedures In Zibo, Shandong, The People's Republic Of China. | - | - | 1994-01-20 |
| Ibuprofen BP 88/usp XXII | 15687-27-1 | - | 1994-11-29 |
Source: ema_cep;FDA_DMF | Updated: 2026-04-09 07:23:02