山东安信制药有限公司
Shandong Anxin Pharmaceutical Co. Ltd.
Country: CN CDE+DMF+CEP VERY_HIGH
🇨🇳 CDE
36
39 products shown
🇺🇸 DMF
19
19 products shown
🇪🇺 CEP
14
14 products shown
Total
69
registrations
🇨🇳 CDE 注册 (39)
| Product | CAS | Status | Reg Number |
|---|---|---|---|
| 恩考芬尼 | - | Class I | Y20260000441 |
| 贝美替尼 | - | Class I | Y20260000539 |
| Amikacin 阿米卡星 | 37517-28-5 | Class A | Y20190001593 |
| Amikacin Sulfate 硫酸阿米卡星 | 39831-55-5 | Class A | Y20190001575 |
| Ampicillin Sodium 氨苄西林钠 | 69-53-4 | Class A | Y20190001541 |
| Aprepitant 阿瑞匹坦 | 170729-80-3 | Class A | Y20180001363 |
| Capecitabine 卡培他滨 | 154361-50-9 | Class A | Y20190008885 |
| Carmofur 卡莫氟 | 61422-45-5 | Class A | Y20190001534 |
| Celecoxib 塞来昔布 | 169590-42-5 | Class A | Y20170000772 |
| Decitabine 地西他滨 | 2353-33-5 | Class I | Y20240000263 |
| Docetaxel 多西他赛 | 114977-28-5 | Class A | Y20250000074 |
| Escitalopram Oxalate 草酸艾司西酞普兰 | 59729-33-8 | Class A | Y20190008896 |
| Etoricoxib 依托考昔 | 202409-33-4 | Class A | Y20170001901 |
| Evt-101 阿普唑仑 | 1189088-41-2 | Class A | Y20190001538 |
| Finerenone, Non-sterile Bulk Drug Substance 非奈利酮 | 1050477-31-0 | Class I | Y20260000440 |
| Fosaprepitant Dimeglumine 福沙匹坦双葡甲胺 | 170729-80-3 | Class A | Y20180001076 |
| Hydroxycarbamide 过氧化碳酰胺 | 57-13-6 | Class A | Y20190001536 |
| Ibrutinib 伊布替尼 | 936563-96-1 | Class A | Y20230000290 |
| Imatinib 硫酸艾玛昔替尼 | 152459-95-5 | Class A | Y20190021643 |
| Imatinib 硫酸艾玛昔替尼 | 152459-95-5 | Class I | Y20180000974 |
| Lenvatinib 甲磺酸仑伐替尼 | 417716-92-8 | Class A | Y20190021453 |
| Montelukast Sodium 孟鲁司特钠 | 158966-92-8 | Class A | Y20170001337 |
| Niraparib Tosylate Monohydrate 甲苯磺酸尼拉帕利 | 1613220-15-7 | Class I | Y20260000432 |
| Olmesartan Medoxomil 奥美沙坦酯 | 144689-63-4 | Class A | Y20170000202 |
| Piperacillin Sodium 哌拉西林钠 | 61477-96-1 | Class A | Y20190009502 |
| Piperacillin Sodium 哌拉西林钠 | 61477-96-1 | Class A | Y20170000228 |
| Ponatinib 盐酸泊那替尼 | 943319-70-8 | Class I | Y20250000177 |
| Quetiapine 富马酸喹硫平 | 111974-69-7 | Class A | Y20170000460 |
| Tadalafil 他达拉非 | 171596-29-5 | Class A | Y20180001768 |
| Tazobactam 他唑巴坦 | 89786-04-9 | Class A | Y20190008388 |
| Tazobactam Sodium 他唑巴坦钠 | 89786-04-9 | Class A | Y20250000214 |
| Tazobactam Sodium 他唑巴坦钠 | 89786-04-9 | Class A | Y20190002975 |
| Tegafur 替加氟 | 17902-23-7 | Class A | Y20190001537 |
| Ticarcillin Sodium 替卡西林钠 | - | Class A | Y20170000799 |
| Tipiracil 盐酸替匹嘧啶 | - | Class A | Y20180001365 |
| Tofacitinib 伊托法替布 | 477600-75-2 | Class A | Y20180001747 |
| Trazodone 盐酸曲唑酮 | 19794-93-5 | Class I | Y20250000875 |
| Trifluridine, Combinations 曲氟尿苷 | - | Class A | Y20180001364 |
| Uracil 尿嘧啶 | 66-22-8 | Class A | Y20190001533 |
🇺🇸 DMF 注册 (19)
🇪🇺 CEP 注册 (14)
| Product | CAS | CEP Number | Date |
|---|---|---|---|
| Amikacin Sulfate 硫酸阿米卡星 | 39831-55-5 | CEP 2010-308 - Rev 02 | 2025-08-25 |
| Aprepitant, Form I, milled | - | CEP 2024-456 - Rev 00 | 2026-05-21 |
| Azithromycin Dihydrate 阿奇霉素枸橼酸二氢钠 | 117772-70-0 | CEP 2025-033 - Rev 00 | 2025-09-15 |
| Capecitabine 卡培他滨 | 154361-50-9 | CEP 2014-189 - Rev 04 | 2024-11-27 |
| Celecoxib 塞来昔布 | 169590-42-5 | R1-CEP 2015-297 - Rev 01 | 2022-08-26 |
| Docetaxel Trihydrate, Shandong Anxin Site | 148408-66-6 | CEP 2025-133 - Rev 00 | 2025-09-17 |
| Hydroxycarbamide 过氧化碳酰胺 | 57-13-6 | CEP 2005-051 - Rev 05 | 2025-09-01 |
| Imatinib Mesilate | 220127-57-1 | R1-CEP 2016-039 - Rev 00 | 2022-06-01 |
| Imatinib Mesilate, Β Form, Milled, Non-milled | 220127-57-1 | CEP 2017-292 - Rev 04 | 2025-04-04 |
| Olmesartan Medoxomil 奥美沙坦酯 | 144689-63-4 | R1-CEP 2014-225 - Rev 00 | 2022-01-05 |
| Piperacillin Monohydrate 哌拉西林 | 66258-76-2 | R1-CEP 2015-389 - Rev 00 | 2022-04-22 |
| Piperacillin Sodium, Sterile 哌拉西林 钠 | 59703-84-3 | CEP 2024-333 - Rev 00 | 2025-05-19 |
| Quetiapine Fumarate 富马酸喹硫平 | 111974-72-2 | R0-CEP 2015-080 - Rev 01 | 2020-01-15 |
| Tadalafil 他达拉非 | 171596-29-5 | R1-CEP 2016-001 - Rev 00 | 2022-02-02 |
Source: cde+fda_direct; DMF高置信 | Updated: 2026-09-11 06:00:12