专论编号 | 物质名称 | 证书持有人 | 持有人ORG-ID和LOC-ID | 证书编号 | 发布日期 | 证书状态 | 到期续期 | 证书结束日期 | 证书类型 | 上一程序的结束日期 | 历史数据 程序类型|结论|日期 |
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2931 | Sorafenib tosilate | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | CEP 2021-247 - Rev 01 | 2024/04/23 | Valid | 10/07/2028 | Chemical | 2024/04/23 | Minor revision|CEP granted|23/04/2024; New application|CEP granted|10/07/2023 |
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1790 | Naltrexone hydrochloride, Wavelength site | NORAMCO, LLC. Wilmington US | 100048651;100080628 | CEP 2020-291 - Rev 02 | 2024/04/23 | Valid | 24/11/2025 | Chemical | 2024/04/23 | Notification|CEP granted|23/04/2024; Notification|CEP granted|17/03/2022; Notification|Accepted - CEP remains valid|19/04/2021; New application|CEP granted|24/11/2020 |
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1656 | Moxidectin for veterinary use, With butylhydroxytoluene, Process II | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2021-423 - Rev 01 | 2024/04/22 | Valid | 21/03/2027 | Chemical | 2024/04/22 | Minor revision|CEP granted|22/04/2024; Minor revision|Accepted - CEP remains valid|28/04/2023; New application|CEP granted|21/03/2022 |
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2174 | Cladribine | HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO., LTD. Jingmen City CN | 100020377;100029131 | CEP 2023-104 - Rev 00 | 2024/04/22 | Valid | 22/04/2029 | Chemical | 2024/04/22 | New application|CEP granted|22/04/2024 | |
627 | Nifedipine | SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN | 100017920;100052986 | CEP 2022-402 - Rev 00 | 2024/04/22 | Valid | 22/04/2029 | Chemical | 2024/04/22 | New application|CEP granted|22/04/2024 | |
2375 | Raloxifene hydrochloride | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2022-165 - Rev 00 | 2024/04/22 | Valid | 22/04/2029 | Chemical | 2024/04/22 | New application|CEP granted|22/04/2024 | |
2988 | Fingolimod hydrochloride | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100022645 | CEP 2022-413 - Rev 00 | 2024/04/22 | Valid | 22/04/2029 | Chemical | 2024/04/22 | New application|CEP granted|22/04/2024 | |
798 | Fusidic acid | JOYANG LABORATORIES Yancheng CN | 100033417;100052265 | CEP 2014-046 - Rev 01 | 2024/04/22 | Valid | Chemical | 2024/04/22 | Minor revision|CEP granted|22/04/2024; Renewal|CEP granted|25/06/2020 |
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2675 | Irinotecan hydrochloride trihydrate | FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN | 100011513;100018607 | CEP 2017-234 - Rev 03 | 2024/04/22 | Valid | Chemical | 2024/10/08 | Minor revision|Accepted - CEP remains valid|08/10/2024; Renewal|CEP granted|22/04/2024; Major revision|Accepted - CEP remains valid|25/10/2023; Minor revision|CEP granted|02/09/2022; Notification|Accepted - CEP remains valid|14/04/2022; Minor revision|Accepted - CEP remains valid|01/06/2021; Minor revision|CEP granted|09/10/2020 |
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1208 | Fenbendazole for veterinary use, Process 2 | Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. Hanzhong CN | 100012369;100079669 | CEP 2018-250 - Rev 02 | 2024/04/22 | Valid | Chemical | 2024/04/22 | Renewal|CEP granted|22/04/2024; Minor revision|CEP granted|28/11/2022 |
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1073 | Biotin | DSM Nutritional Products Ltd. Kaiseraugst CH | 100012007;100022521 | CEP 2001-405 - Rev 06 | 2024/04/22 | Valid | Chemical | 2024/04/22 | Minor revision|CEP granted|22/04/2024; Minor revision|CEP granted|16/01/2023; Minor revision|CEP granted|02/02/2022 |
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2015 | Ebastine | BAL PHARMA LIMITED Bengaluru IN | 100016398;100041736 | CEP 2013-051 - Rev 02 | 2024/04/22 | Valid | Chemical | 2024/04/22 | Notification|CEP granted|22/04/2024; Minor revision|CEP granted|28/11/2022 |
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627 | Nifedipine | Moehs Iberica S.L. Rubi ES | 100029092;100068825 | CEP 1996-105 - Rev 05 | 2024/04/22 | Valid | Chemical | 2024/04/22 | Minor revision|CEP granted|22/04/2024 | ||
1575 | Tiapride hydrochloride | Laboratorios Espinos Y Bofill S.A. (LEBSA) Cornellà ES | 100021595;100030302 | CEP 2018-066 - Rev 01 | 2024/04/19 | Valid | Chemical | 2024/04/19 | Renewal|CEP granted|19/04/2024; Minor revision|Accepted - CEP remains valid|03/02/2022 |
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3087 | Ticagrelor | PHARMARESOURCES (KAIYUAN) COMPANY LIMITED Kaiyuan City CN | 100037212;100058809 | CEP 2021-362 - Rev 00 | 2024/04/19 | Valid | 19/04/2029 | Chemical | 2024/04/19 | New application|CEP granted|19/04/2024 | |
1103 | Fentanyl citrate | AREVIPHARMA GMBH Radebeul DE | 100011616;100022155 | CEP 2007-340 - Rev 02 | 2024/04/19 | Valid | Chemical | 2024/04/19 | Administrative procedure|CEP granted|19/04/2024; Minor revision|Accepted - CEP remains valid|15/04/2024; Notification|Accepted - CEP remains valid|17/02/2021 |
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2765 | Eplerenone | JPN PHARMA PVT LTD Boisar IN | 100024390;100061494 | CEP 2021-373 - Rev 00 | 2024/04/19 | Valid | 19/04/2029 | Chemical | 2024/04/19 | New application|CEP granted|19/04/2024 | |
1114 | Iohexol | DIVI'S LABORATORIES LIMITED Hyderabad IN | 100011666;100052116 | CEP 2022-240 - Rev 00 | 2024/04/19 | Valid | 19/04/2029 | Chemical | 2024/09/26 | Minor revision|Accepted - CEP remains valid|26/09/2024; New application|CEP granted|19/04/2024 |
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2993 | Nilotinib hydrochloride monohydrate | RAVI BIOLIFE PRIVATE LTD. Mumbai IN | 100048404;100086771 | CEP 2022-425 - Rev 00 | 2024/04/19 | Valid | 19/04/2029 | Chemical | 2024/04/19 | New application|CEP granted|19/04/2024 | |
718 | Glibenclamide, Non-micronised, micronised | USV PRIVATE LIMITED Mumbai IN | 100006251;100010851 | CEP 2000-090 - Rev 05 | 2024/04/19 | Valid | Chemical | 2024/04/19 | Minor revision|CEP granted|19/04/2024; Notification|Rejected|22/01/2024 |