山东新时代药业有限公司
Shandong New Time Pharmaceutical Co. Ltd.
🇨🇳 CDE
141
141 products shown
🇺🇸 DMF
44
44 products shown
🇪🇺 CEP
9
9 products shown
Total
194
registrations
🇨🇳 CDE 注册 (141)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| Aceclofenac 醋氯芬酸 | 89796-99-6 | Class A | Y20200000569 |
| Acipimox 阿昔莫司 | 51037-30-0 | Class A | Y20190002764 |
| Alfuzosin 盐酸阿夫唑嗪 | 81403-80-7 | Class A | Y20190002344 |
| Amlodipine 氨氯地平 | 88150-42-9 | Class A | Y20190002117 |
| Aniracetam 茴拉西坦 | 72432-10-1 | Class A | Y20190001446 |
| Apalutamide 阿帕他胺 | 956104-40-8 | Class I | Y20250000313 |
| Apixaban 阿哌沙班 | 503612-47-3 | Class A | Y20220000194 |
| Apremilast 阿普斯特 | 608141-41-9 | Class A | Y20220000367 |
| Aprepitant 阿瑞匹坦 | 170729-80-3 | Class A | Y20230000180 |
| Argatroban 阿加曲班一水合物 | 74863-84-6 | Class A | Y20170000398 |
| Atomoxetine 盐酸托莫西汀 | 83015-26-3 | Class I | Y20230000755 |
| Atorvastatin Calcium 阿托伐他汀钙 | 134523-00-5 | Class A | Y20170000103 |
| Axitinib 阿昔替尼 | 319460-85-0 | Class A | Y20190021244 |
| Azacitidine 阿扎胞苷 | 320-67-2 | Class A | Y20200000659 |
| Azilsartan Medoxomil 阿齐沙坦 | 863031-21-4 | Class A | Y20240000327 |
| Azilsartan Medoxomil Potassium MY008211A | 863031-21-4 | Class I | Y20240001210 |
| Baricitinib 巴瑞替尼 | 1187594-09-7 | Class I | Y20250000801 |
| Bilastine 比拉斯汀 | 202189-78-4 | Class A | Y20230000151 |
| Bortezomib 硼替佐米 | 179324-69-7 | Class I | Y20250001463 |
| Bortezomib 硼替佐米 | 179324-69-7 | Class I | Y20250001236 |
| Brexpiprazole 布瑞哌唑 | 913611-97-9 | Class I | Y20240001445 |
| Butylphthalide 丁苯酞 | 6066-49-5 | Class A | Y20230000032 |
| Capecitabine 卡培他滨 | 154361-50-9 | Class A | Y20170000428 |
| Carfilzomib 卡非佐米 | 868540-17-4 | Class A | Y20230000582 |
| Cetylpyridinium Chloride 西吡氯铵 | 7773-52-6 | Class A | Y20210001271 |
| Chlorzoxazone 氯唑沙宗 | 95-25-0 | Class A | Y20230000235 |
| Choline Fenofibrate 非诺贝特酸胆碱 | 856676-23-8 | Class A | Y20210001178 |
| Cilastatin Sodium 西司他丁钠 | 81129-83-1 | Class A | Y20190007361 |
| Clopidogrel 氯吡格雷 | 113665-84-2 | Class A | Y20190008257 |
| Crisaborole 克立硼罗 | 906673-24-3 | Class A | Y20230000380 |
| Dasatinib 达沙替尼 | 302962-49-8 | Class A | Y20170000900 |
| Daunorubicin 盐酸柔红霉素 | 20830-81-3 | Class A | Y20190006712 |
| Decitabine 地西他滨 | 2353-33-5 | Class A | Y20190006711 |
| Dexborneol 右莰醇 | 464-43-7 | Class I | Y20250001402 |
| Dexibuprofen 右旋布洛芬 | 51146-56-6 | Class A | Y20170000726 |
| Doxorubicin 盐酸多柔比星 | 23214-92-8 | Class A | Y20240000966 |
| Dronedarone 盐酸决奈达隆 | 141626-36-0 | Class A | Y20240000678 |
| Dyclonine 盐酸达克罗宁 | 586-60-7 | Class A | Y20220000023 |
| Edoxaban Tosylate 甲苯磺酸艾多沙班 | 480449-70-5 | Class A | Y20210000644 |
| Eltrombopag Olamine 艾曲泊帕乙醇胺 | 496775-61-2 | Class A | Y20230000116 |
| Enoxaparin Sodium 依诺肝素钠 | 679809-58-6 | Class A | Y20170001372 |
| Entecavir 恩替卡伟 | 142217-69-4 | Class A | Y20170000757 |
| Enzalutamide 氘恩扎鲁胺 | 915087-33-1 | Class I | Y20240001008 |
| Epirubicin 盐酸表柔比星 | 56420-45-2 | Class A | Y20190006708 |
| Esmolol 盐酸艾司洛尔 | 81147-92-4 | Class A | Y20190007192 |
| Esomeprazole Sodium 埃索美拉唑镁 | 119141-88-7 | Class A | Y20170000429 |
| Etodolac 依托度酸 | 41340-25-4 | Class A | Y20190001990 |
| Everolimus 依维莫司 | 159351-69-6 | Class I | Y20230000177 |
| Ezetimibe 依折麦布 | 163222-33-1 | Class A | Y20210000182 |
| Fampridine 达伐吡啶 | 504-24-5 | Class I | Y20250000691 |
| Faropenem Sodium 法罗培南钠 | 106560-14-9 | Class A | Y20190005136 |
| Fasudil 盐酸法舒地尔 | 103745-39-7 | Class A | Y20170000421 |
| Fludarabine Phosphate 磷酸氟达拉滨 | 21679-14-1 | Class A | Y20170000982 |
| Fulvestrant 氟维司群 | 129453-61-8 | Class A | Y20200001165 |
| Gadobutrol 钆布醇 | 770691-21-9 | Class A | Y20200000846 |
| Gadoteric Acid Meglumine 钆特酸葡胺 | 72573-82-1 | Class A | Y20220000723 |
| Gadoteridol 钆特醇 | 120066-54-8 | Class I | Y20250001000 |
| Gefitinib 吉非替尼 | 184475-35-2 | Class A | Y20220000085 |
| Gimeracil 吉美嘧啶 | 103766-25-2 | Class A | Y20190007184 |
| Ibrutinib 伊布替尼 | 936563-96-1 | Class I | Y20240000915 |
| Imipenem And Cilastatin 亚胺培南 | 92309-29-0 | Class A | Y20190007359 |
| Ipratropium Bromide 异丙托溴铵 | 22254-24-6 | Class A | Y20190000617 |
| Isoflurane 异氟烷 | 26675-46-7 | Class A | Y20190006467 |
| Isosorbide 异山梨醇 | 87-33-2 | Class A | Y20200000099 |
| Isosorbide Dinitrate 硝酸异山梨酯 | 87-33-2 | Class A | Y20170001357 |
| Isosorbide Mononitrate 单硝酸异山梨酯 | 16051-77-7 | Class A | Y20190002360 |
| Ivabradine 盐酸伊伐布雷定 | 155974-00-8 | Class A | Y20190000673 |
| Ixazomib 枸橼酸伊沙佐米 | 1239908-20-3 | Class I | Y20240001475 |
| Ketorolac Tromethamine 酮咯酸氨丁三醇 | 74103-06-3 | Class A | Y20190021247 |
| Ketorolac Tromethamine 酮咯酸氨丁三醇 | 74103-06-3 | Class A | Y20190003666 |
| Lenvatinib 甲磺酸仑伐替尼 | 417716-92-8 | Class A | Y20210000870 |
| Lidocaine 利多卡因 | 137-58-6 | Class A | Y20210000152 |
| Lifitegrast 立他司特 | 1025967-78-5 | Class I | Y20220000061 |
| Linagliptin 利格列汀 | 668270-12-0 | Class A | Y20210000483 |
| Lurasidone 盐酸鲁拉西酮 | 367514-87-2 | Class I | Y20240001450 |
| Manganese 硫酸锰 | 7785-87-7 | Class I | Y20250000605 |
| Menatetrenone 四烯甲萘醌 | 863-61-6 | Class A | Y20240000634 |
| Metoprolol 琥珀酸美托洛尔 | 98474-52-3 | Class A | Y20200000203 |
| Miglitol 米格列醇 | 72432-03-2 | Class A | Y20190007138 |
| Minodronic Acid 米诺膦酸 | 180064-38-4 | Class A | Y20210001126 |
| Monosialotetrahexosylganglioside Sodium 单唾液酸四己糖神经节苷脂钠 | 85416-39-5 | Class I | Y20170000054 |
| Montelukast Sodium 孟鲁司特钠 | 158966-92-8 | Class A | Y20190000411 |
| Montelukast Sodium 孟鲁司特钠 | 158966-92-8 | Class I | Y20170001683 |
| Mosapride 枸橼酸莫沙必利 | 112885-41-3 | Class A | Y20190004116 |
| Mycophenolate Mofetil 吗替麦考酚酯 | 128794-94-5 | Class A | Y20190002063 |
| Mycophenolate Sodium 麦考酚钠 | 37415-62-6 | Class A | Y20230001035 |
| Nalfurafine 盐酸纳呋拉啡 | 152657-84-6 | Class A | Y20230000880 |
| Nevirapine 奈韦拉平 | 129618-40-2 | Class A | Y20190006329 |
| Olaparib 奥拉帕利 | 763113-22-0 | Class I | Y20240001221 |
| Orlistat 奥利司他 | 96829-58-2 | Class A | Y20190007185 |
| Palbociclib 帕博西尼 | 571190-30-2 | Class A | Y20230000379 |
| Parecoxib Sodium 帕瑞昔布钠 | 198470-84-7 | Class A | Y20200000754 |
| Pemetrexed Disodium 培美曲塞二钠 | 137281-23-3 | Class A | Y20170000641 |
| Phloroglucinol 间苯三酚三甲醚 | 108-73-6 | Class A | Y20210001037 |
| Pirfenidone 吡非尼酮 | 53179-13-8 | Class A | Y20240000922 |
| Plerixafor 普乐沙福 | 110078-46-1 | Class A | Y20230000140 |
| Policresulen 聚甲酚磺醛 | - | Class A | Y20200000753 |
| Posaconazole 泊沙康唑 | 171228-49-2 | Class A | Y20230001335 |
| Potassium Clavulanate WXSH0150 | - | Class A | Y20190006713 |
| Potassium Oxonate 奥替拉西钾 | 2207-75-2 | Class A | Y20190007300 |
| Pralatrexate 普拉曲沙 | 146464-95-1 | Class I | Y20240000511 |
| Prucalopride 琥珀酸普芦卡必利 | 179474-81-8 | Class A | Y20220000146 |
| Ramipril 雷米普利 | 87333-19-5 | Class A | Y20170001033 |
| Revefenacin 雷芬那辛 | 864750-70-9 | Class I | Y20250000816 |
| Rivaroxaban 利伐沙班 | 366789-02-8 | Class A | Y20190000588 |
| Rosuvastatin Calcium 瑞舒伐他汀钙 | 287714-41-4 | Class A | Y20190007037 |
| Roxadustat 罗沙司他 | 808118-40-3 | Class A | Y20230000551 |
| Ruxolitinib 磷酸芦可替尼 | 941678-49-5 | Class A | Y20230000288 |
| Sacubitril/valsartan Sodium 沙库巴曲缬沙坦钠 | 137862-53-4 | Class A | Y20220000888 |
| Selenious Acid 亚硒酸 | - | Class I | Y20250000615 |
| Selenium Sulfide 二硫化硒 | 7446-34-6 | Class I | Y20260000182 |
| Sevoflurane 七氟烷 | 28523-86-6 | Class A | Y20190007191 |
| Simeticone 西甲硅油 | - | Class A | Y20230000438 |
| Sitagliptin 西格列汀 | 486460-32-6 | Class A | Y20220000907 |
| Sivelestat Sodium 西维来司他钠 | 201677-61-4 | Class I | Y20240001529 |
| Sodium Bicarbonate 碳酸氢钠 | 144-55-8 | Class I | Y20250000639 |
| Sodium Bicarbonate 碳酸氢钠 | 144-55-8 | Class A | Y20240000414 |
| Somatostatin 生长抑素 | 38916-34-6 | Class A | Y20190003674 |
| Tacrolimus 他克莫司 | 104987-11-3 | Class I | Y20170000052 |
| Tadalafil 他达拉非 | 171596-29-5 | Class A | Y20230000248 |
| Tegafur 替加氟 | 17902-23-7 | Class A | Y20170000183 |
| Tenofovir Disoproxil 酒石酸替诺福韦二吡呋酯 | 201341-05-1 | Class A | Y20190006669 |
| Tipiracil 盐酸替匹嘧啶 | - | Class A | Y20220000039 |
| Tofacitinib 伊托法替布 | 477600-75-2 | Class A | Y20220001033 |
| Tolterodine 酒石酸托特罗定 | 124937-51-5 | Class A | Y20190005126 |
| Topiramate 托吡酯 | 97240-79-4 | Class A | Y20220000349 |
| Trelagliptin 琥珀酸曲格列汀 | 1029877-94-8 | Class I | Y20200000352 |
| Trifluridine, Combinations 曲氟尿苷 | - | Class A | Y20220001186 |
| Valaciclovir 盐酸伐昔洛韦 | 124832-26-4 | Class A | Y20190007761 |
| Valsartan 缬沙坦 | 137862-53-4 | Class A | Y20230000308 |
| Varenicline 酒石酸伐尼克兰 | 249296-44-4 | Class A | Y20240000621 |
| Venetoclax 维奈克拉 | 1257044-40-8 | Class I | Y20250001444 |
| Vericiguat 维立西呱 | 1350653-20-1 | Class I | Y20250001068 |
| Vonoprazan 富马酸伏诺拉生 | 881681-00-1 | Class A | Y20190021308 |
| Vortioxetine 氢溴酸伏硫西汀 | 508233-74-7 | Class I | Y20240001098 |
| Zanamivir 扎那米韦 | 139110-80-8 | Class A | Y20190009770 |
| Zanamivir 扎那米韦 | 139110-80-8 | Class A | Y20170002031 |
| Zidovudine 齐多夫定 | 30516-87-1 | Class A | Y20190005144 |
| Zoledronic Acid 唑来膦酸 | 118072-93-8 | Class A | Y20220000726 |
| Zoledronic Acid 唑来膦酸 | 118072-93-8 | Class A | Y20190002001 |
| Zolmitriptan 佐米曲普坦 | 139264-17-8 | Class A | Y20190003660 |
🇺🇸 DMF 注册 (44)
| Product | CAS | DMF Number | Date |
|---|---|---|---|
| Alfuzosin Hydrochloride 盐酸阿呋唑嗪 | 81403-80-7 | - | 2006-12-01 |
| Aminodesacetoxycephalosporanic Acid (7-adca) | 22252-43-3 | - | 2007-12-12 |
| Bempedoic Acid 贝派度酸 | 738606-46-7 | - | 2022-04-23 |
| Cabazitaxel 卡巴他赛 | 183133-96-2 | - | 2025-12-09 |
| Calteridol Calcium 卡尔特罗钙 | 121915-83-1 | - | 2025-12-06 |
| Carfilzomib 卡非佐米 | 868540-17-4 | - | 2023-09-06 |
| Clavulanate Potassium 克拉维酸钾-二氧化硅(1:1) | 26787-78-0 | - | 2012-01-16 |
| Dalfampridine 达伐吡啶 | 504-24-5 | - | 2025-07-25 |
| Daunorubicin Hydrochloride 盐酸柔红霉素 | 23541-50-6 | - | 1990-11-16 |
| Decitabine 地西他滨 | 2353-33-5 | - | 2014-03-12 |
| Diluted Isosorbide Dinitrate USP 异山梨醇 | 87-33-2 | - | 2021-12-05 |
| Diluted Isosorbide Mononitrate (60%) 单硝酸异山梨酯70%,乳糖稀释 | 16051-77-7 | - | 2009-10-21 |
| Diluted Isosorbide Mononitrate (70%) 单硝酸异山梨酯70%,乳糖稀释 | 16051-77-7 | - | 2009-10-21 |
| Diluted Isosorbide Mononitrate USP 单硝酸异山梨酯70%,乳糖稀释 | 16051-77-7 | - | 2015-07-17 |
| Elagolix Sodium 艾拉戈克钠 | 834153-87-6 | - | 2021-12-30 |
| Epirubicin Hydrochloride 盐酸表柔比星 | 56390-09-1 | - | 2002-12-18 |
| Epirubicin Hydrochloride USP 盐酸表柔比星 | 56390-09-1 | - | 2023-02-15 |
| Esomeprazole Sodium 埃索美拉唑镁 | 119141-88-7 | - | 2021-11-12 |
| Fosaprepitant Dimeglumine 福沙匹坦双葡甲胺 | 170729-80-3 | - | 2021-03-21 |
| Gadoteridol USP 钆特醇 | 120066-54-8 | - | 2025-09-16 |
| Gimeracil 吉美嘧啶 | 103766-25-2 | - | 2021-05-31 |
| Isoflurane (non-sterile Bulk) 异氟烷 | 26675-46-7 | - | 2005-11-28 |
| Isoflurane USP 异氟烷 | 26675-46-7 | - | 2020-12-22 |
| Isosorbide Mononitrate (non-sterile, Bulk Form) 单硝酸异山梨酯70%,乳糖稀释 | 16051-77-7 | - | 2007-08-24 |
| Ketorolac Tromethamine (non-sterile, Bulk Form) | 74103-07-4 | - | 2009-01-16 |
| Ketorolac Tromethamine USP 酮咯酸氨丁三醇 | 74103-07-4 | - | 2022-09-18 |
| Lasmiditan Hemisuccinate 拉米地坦 | 439239-92-6 | - | 2023-07-31 |
| Linagliptin 利格列汀 | 668270-12-0 | - | 2014-11-19 |
| Milrinone, USP 米力农 | 78415-72-2 | - | 2021-03-12 |
| Montelukast Sodium USP 孟鲁司特钠 | 151767-02-1 | - | 2019-08-13 |
| Mycophenolate Mofetil 吗替麦考酚酯 | 128794-94-5 | - | 2009-07-22 |
| Orlistat 奥利司他 | 96829-58-2 | - | 2008-10-24 |
| Oteracil Potassium 奥替拉西钾 | 2207-75-2 | - | 2021-01-23 |
| Potassium Clavulanate Diluted With Silicon Dioxide In The Ratio 1:1 克拉维酸钾/微晶纤维素混合物(1:1) | 61177-45-5 | - | 2012-01-16 |
| Potassium Clavulanate, Diluted With Microcrystalline Cellulose In The Ratio 1:1 克拉维酸钾/微晶纤维素混合物(1:1) | 61177-45-5 | - | 2012-01-16 |
| Potassium Clavulanate, Diluted, Non-sterile Bulk Form 克拉维酸钾/微晶纤维素混合物(1:1) | 61177-45-5 | - | 2006-06-16 |
| Sevoflurane (non-sterile Bulk Form) 七氟烷 | 28523-86-6 | - | 2005-12-20 |
| Sevoflurane USP 七氟烷 | 28523-86-6 | - | 2016-09-28 |
| Sitagliptin Phosphate USP | 654671-78-0 | - | 2021-08-12 |
| Tadalafil 他达拉非 | 171596-29-5 | - | 2019-04-11 |
| Tegafur 替加氟 | 17902-23-7 | - | 2021-12-20 |
| Temsirolimus 西罗莫司 | 162635-04-3 | - | 2025-01-11 |
| Zoledronic Acid 唑来膦酸 | 118072-93-8 | - | 2010-11-08 |
| Zoledronic Acid Monohydrate 唑来膦酸 | 165800-06-6 | - | 2021-05-18 |
🇪🇺 CEP 注册 (9)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Alfuzosin Hydrochloride 盐酸阿呋唑嗪 | 81403-80-7 | R0-CEP 2008-309 - Rev 00 | - |
| Isoflurane 异氟烷 | 26675-46-7 | CEP 2010-078 - Rev 02 | - |
| Isosorbide Mononitrate, Diluted, 70%, 60%, 50%, 40% In Lactose Monohydrate 单硝酸异山梨酯70%,乳糖稀释 | 16051-77-7 | R0-CEP 2020-153 - Rev 00 | - |
| Montelukast Sodium 孟鲁司特钠 | 158966-92-8 | R0-CEP 2019-211 - Rev 00 | - |
| Potassium Clavulanate WXSH0150 | - | CEP 2011-374 - Rev 01 | - |
| Potassium Clavulanate, Diluted With Microcrystalline Cellulose In The Ratio 1:1 克拉维酸钾/微晶纤维素混合物(1:1) | 61177-45-5 | CEP 2011-375 - Rev 03 | - |
| Potassium Clavulanate, Diluted, With Silicone Dioxide In The Ratio 1:1 克拉维酸钾/微晶纤维素混合物(1:1) | 61177-45-5 | CEP 2011-376 - Rev 03 | - |
| Sevoflurane 七氟烷 | 28523-86-6 | CEP 2012-234 - Rev 01 | - |
| Zoledronic Acid Monohydrate 唑来膦酸 | 165800-06-6 | R0-CEP 2021-177 - Rev 00 | - |
Source: cde_raw;FDA_DMF | Updated: 2026-04-09 07:23:01