江苏恩华药业股份有限公司
Jiangsu Nhwa Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
68
68 products shown
🇺🇸 DMF
4
4 products shown
🇪🇺 CEP
2
2 products shown
Total
74
registrations
🇨🇳 CDE 注册 (68)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| CY150112 | - | Class I | Y20200000220 |
| Alfentanil Hydrochloride 盐酸阿芬太尼 | 71195-58-9 | Class A | Y20190000841 |
| Aripiprazole 阿立哌唑 | 129722-12-9 | Class A | Y20190001422 |
| Brexpiprazole 布瑞哌唑 | 913611-97-9 | Class I | Y20250000258 |
| Bupropion 盐酸安非他酮 | 34911-55-2 | Class I | Y20260000246 |
| Buspirone 盐酸丁螺环酮 | 36505-84-7 | Class A | Y20190003880 |
| Cilostazol 西洛他唑 | 73963-72-1 | Class A | Y20190004221 |
| Citalopram 西酞普兰 | 59729-33-8 | Class A | Y20190009588 |
| Citalopram 西酞普兰 | 59729-33-8 | Class A | Y20170001973 |
| Clomipramine 盐酸氯米帕明 | 303-49-1 | Class A | Y20190004054 |
| Clonazepam 氯硝西泮 | 1622-61-3 | Class A | Y20190009582 |
| Clonazepam 氯硝西泮 | 1622-61-3 | Class A | Y20170001892 |
| Clozapine 氯氮平 | 5786-21-0 | Class A | Y20210000420 |
| Dexketoprofen Tromethamine 右酮洛芬氨丁三醇 | 175676-42-3 | Class A | Y20240000499 |
| Dexmedetomidine 盐酸右美托咪定 | 113775-47-6 | Class A | Y20190006376 |
| Doxapram 盐酸多沙普仑 | - | Class A | Y20190003882 |
| Duloxetine 盐酸度洛西汀 | 116539-59-4 | Class A | Y20190007215 |
| Econazole 硝酸益康唑 | 27220-47-9 | Class A | Y20190009583 |
| Econazole 硝酸益康唑 | 27220-47-9 | Class A | Y20170002003 |
| Etomidate 甲氧依托咪酯盐酸盐 | 33125-97-2 | Class A | Y20190003881 |
| Fenofibrate NH600001 | 49562-28-9 | Class I | Y20250000697 |
| Fenofibrate NH600001 | 49562-28-9 | Class A | Y20190003910 |
| Fentanyl Citrate 枸橼酸芬太尼 | 437-38-7 | Class A | Y20190006561 |
| Flumazenil 氟马西尼 | 78755-81-4 | Class A | Y20190003915 |
| Flutrimazole 氟曲马唑 | 119006-77-8 | Class A | Y20170000865 |
| Gabapentin 加巴喷丁 | 60142-96-3 | Class A | Y20190004231 |
| Ketamine 盐酸(R)-氯胺酮 | 6740-88-1 | Class I | Y20250000820 |
| Ketoconazole 酮康唑 | 65277-42-1 | Class A | Y20190003909 |
| Levomethadone 盐酸左美沙酮 | 125-58-6 | Class I | Y20250000632 |
| Levomilnacipran 盐酸左米那普仑 | 96847-54-0 | Class I | Y20250001254 |
| Lithium Carbonate 碳酸锂 | 7439-93-2 | Class A | Y20190003917 |
| Lorazepam 劳拉西泮 | 846-49-1 | Class A | Y20240000388 |
| Miconazole 硝酸咪康唑 | 22832-87-7 | Class A | Y20190009584 |
| Miconazole 硝酸咪康唑 | 22832-87-7 | Class A | Y20170002001 |
| Midazolam 咪达唑仑 | 59467-70-8 | Class A | Y20200000399 |
| Midazolam 咪达唑仑 | 59467-70-8 | Class A | Y20190003911 |
| Midazolam Maleate 马来酸咪达唑仑 | 59467-70-8 | Class A | Y20190003914 |
| Mivacurium Chloride 米库氯铵 | 106861-44-3 | Class A | Y20230000574 |
| Naloxone 盐酸纳洛酮 | 465-65-6 | Class A | Y20190009581 |
| Naloxone 盐酸纳洛酮 | 465-65-6 | Class I | Y20170002013 |
| Naproxen 萘普生 | 22204-53-1 | Class A | Y20190003916 |
| Nitrazepam 硝西泮 | 146-22-5 | Class A | Y20190003890 |
| Nizatidine 尼扎替丁 | 76963-41-2 | Class A | Y20190003908 |
| Olanzapine 奥氮平 | 132539-06-1 | Class A | Y20170000211 |
| Oliceridine Oliceridine 富马酸盐 | 1401028-24-7 | Class A | Y20210001272 |
| Oliceridine Oliceridine 富马酸盐 | 1401028-24-7 | Class I | Y20200000127 |
| Paliperidone 棕榈酸帕利哌酮 | 144598-75-4 | Class I | Y20250000957 |
| Paroxetine 帕罗西汀 | 61869-08-7 | Class I | Y20170000941 |
| Penehyclidine 盐酸戊乙奎醚 | - | Class A | Y20170000844 |
| Pregabalin 普瑞巴林 | 148553-50-8 | Class A | Y20170001560 |
| Propofol 丙泊酚 | 2078-54-8 | Class A | Y20190006648 |
| Quetiapine 富马酸喹硫平 | 111974-69-7 | Class A | Y20170001025 |
| Riluzole 利鲁唑 | 1744-22-5 | Class A | Y20190004077 |
| Risperidone 利培酮 | 106266-06-2 | Class A | Y20190009586 |
| Risperidone 利培酮 | 106266-06-2 | Class A | Y20170002168 |
| Ropivacaine 盐酸罗哌卡因 | 84057-95-4 | Class A | Y20190004053 |
| Sufentanil 枸橼酸舒芬太尼 | 56030-54-7 | Class A | Y20190021647 |
| Sulpiride 舒必利 | 15676-16-1 | Class A | Y20200000177 |
| Tapentadol 盐酸他喷他多 | 175591-23-8 | Class A | Y20210001193 |
| Tiapride 盐酸硫必利 | 51012-32-9 | Class A | Y20240000763 |
| Triazolam 三唑仑 | 28911-01-5 | Class A | Y20190004078 |
| Vecuronium Bromide 维库溴铵 | 86029-43-8 | Class A | Y20190006367 |
| Viloxazine 盐酸维洛沙秦 | 46817-91-8 | Class I | Y20250000855 |
| Vortioxetine 氢溴酸伏硫西汀 | 508233-74-7 | Class A | Y20230000789 |
| Zaleplon 扎来普隆 | 151319-34-5 | Class A | Y20190004076 |
| Ziprasidone 甲磺酸齐拉西酮三水合物 | 146939-27-7 | Class A | Y20190009730 |
| Ziprasidone 甲磺酸齐拉西酮三水合物 | 146939-27-7 | Class A | Y20190007393 |
| Ziprasidone 甲磺酸齐拉西酮三水合物 | 146939-27-7 | Class A | Y20170002014 |
🇺🇸 DMF 注册 (4)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Buspirone Hydrochloride USP | 33386-08-2 | - | 2024-12-31 |
| Fenofibrate NH600001 | 49562-28-9 | - | 2010-11-18 |
| Gabapentin 加巴喷丁 | 60142-96-3 | - | 2007-08-20 |
| Lithium Carbonate USP 碳酸锂 | 554-13-2 | - | 2025-12-03 |
🇪🇺 CEP 注册 (2)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Fenofibrate NH600001 | 49562-28-9 | CEP 2007-350 - Rev 02 | - |
| Lithium Carbonate 碳酸锂 | 7439-93-2 | CEP 2023-247 - Rev 01 | - |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-04-09 07:23:01