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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1028 | Metoprolol tartrate | IPCA Laboratories Limited Mumbai IN | 100011685;100018680 | R1-CEP 2003-091 - Rev 04 | 2023/03/16 | Valid | Chemical | 2023/03/16 | Minor revision|CEP granted|16/03/2023 | ||
595 | Bisacodyl | DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN | 100062133 | R1-CEP 2007-163 - Rev 03 | 2023/03/16 | Valid | Chemical | 2023/03/16 | Minor revision|CEP granted|16/03/2023 | ||
896 | Deferoxamine mesilate, Produced by a synthetic process | EXCELLA GMBH & CO. KG Feucht DE | 100012030;100020739 | R1-CEP 2009-401 - Rev 04 | 2023/03/16 | Valid | Chemical | 2023/03/16 | Minor revision|CEP granted|16/03/2023 | ||
2465 | Irbesartan | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | R1-CEP 2011-153 - Rev 04 | 2023/03/16 | Valid | Chemical | 2023/03/16 | Major revision|CEP granted|16/03/2023; Minor revision|CEP granted|30/08/2021 |
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992 | Cefuroxime sodium, Sterile | ZHEJIANG DONGYING PHARMACEUTICAL CO., LTD. Shaoxing CN | 100047603;100078635 | R0-CEP 2021-308 - Rev 00 | 2023/03/15 | Valid | 15/03/2028 | Chemical | 2023/03/15 | New application|CEP granted|15/03/2023 | |
1286 | Alfacalcidol | CARBOGEN AMCIS B.V. Veenendaal NL | R1-CEP 1998-097 - Rev 09 | 2023/03/15 | Valid | Chemical and TSE | 2023/03/15 | Notification|CEP granted|15/03/2023; Notification|CEP granted|09/03/2022 |
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330 | Gelatin, Limed hide gelatin | ITALGEL S.P.A. Santa Vittoria D'alba IT | R1-CEP 2000-312 - Rev 03 | 2023/03/15 | Valid | TSE | 2023/03/15 | Notification|CEP granted|15/03/2023; Notification|CEP granted|07/04/2022 |
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577 | Amoxicillin sodium, Sterile | ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN | 100022945;100052547 | R1-CEP 2013-125 - Rev 03 | 2023/03/15 | Valid | Chemical | 2023/03/15 | Major revision|CEP granted|15/03/2023; Major revision|CEP granted|05/08/2022; Major revision|CEP granted|06/11/2020 |
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1104 | Fluoxetine hydrochloride | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | R1-CEP 2013-199 - Rev 02 | 2023/03/15 | Valid | Chemical | 2024/04/16 | Minor revision|Accepted - CEP remains valid|16/04/2024; Minor revision|Accepted - CEP remains valid|12/12/2023; Minor revision|CEP granted|15/03/2023; Minor revision|Accepted - CEP remains valid|01/03/2021; Monograph revision|CEP granted|14/12/2020; Minor revision|Accepted - CEP remains valid|09/06/2020 |
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199 | Oxytetracycline dihydrate | YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. Yangzhou CN | 100023496;100032638 | R1-CEP 2017-105 - Rev 00 | 2023/03/15 | Valid | Chemical | 2023/03/15 | Renewal|CEP granted|15/03/2023 | ||
1511 | Enoxolone | Alps Pharmaceutical Ind. Co., Ltd. Hida JP | 100011598;100021193 | R0-CEP 2016-098 - Rev 01 | 2023/03/14 | Expired | 2023/08/02 | Chemical | 2023/03/14 | ||
38 | Levodopa | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | R0-CEP 2022-320 - Rev 00 | 2023/03/14 | Valid | 14/03/2028 | Chemical | 2023/03/14 | New application|CEP granted|14/03/2023 | |
1416 | Dihydroergocristine mesilate | CURIA ITALY S.R.L. Rozzano, Milano IT | R1-CEP 2000-073 - Rev 07 | 2023/03/14 | Valid | Chemical | 2023/03/14 | Minor revision|CEP granted|14/03/2023; Notification|CEP granted|05/08/2021; Minor revision|CEP granted|18/03/2020 |
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749 | Vincristine sulfate | MINAKEM HIGH POTENT Mont-Saint-Guibert BE | 100011725;100022401 | R1-CEP 2004-048 - Rev 05 | 2023/03/14 | Valid | Chemical | 2023/03/14 | Minor revision|CEP granted|14/03/2023; Minor revision|Accepted - CEP remains valid|13/07/2022 |
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2064 | Chondroitin sulfate sodium, Terrestrial avian origin | ROVAFARM ARGENTINA S.A. Partido de La Matanza AR | R1-CEP 2007-058 - Rev 02 | 2023/03/14 | Valid | Chemical | 2023/03/14 | Major revision|CEP granted|14/03/2023; Notification|CEP granted|19/11/2020 |
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1548 | Nimesulide | MANGALAM DRUGS & ORGANICS LTD. Mumbai IN | R1-CEP 2011-310 - Rev 01 | 2023/03/13 | Valid | Chemical | 2023/03/13 | Minor revision|CEP granted|13/03/2023 | |||
199 | Oxytetracycline dihydrate | CHIFENG PHARMACEUTICAL CO., LTD. Chifeng CN | R1-CEP 2002-035 - Rev 03 | 2023/03/13 | Valid | Chemical | 2023/03/13 | Minor revision|CEP granted|13/03/2023 | |||
199 | Oxytetracycline dihydrate, Process B | CHIFENG PHARMACEUTICAL CO., LTD. Chifeng CN | R1-CEP 2009-053 - Rev 02 | 2023/03/13 | Valid | Chemical | 2023/03/13 | Minor revision|CEP granted|13/03/2023 | |||
1045 | Sulpiride | ICROM S.R.L. Concorezzo IT | 100022464;100031145 | R1-CEP 2011-074 - Rev 03 | 2023/03/13 | Valid | Chemical | 2023/03/13 | Minor revision|CEP granted|13/03/2023; Notification|CEP granted|27/11/2020; Minor revision|CEP granted|25/02/2020 |
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2600 | Olmesartan medoxomil | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | R1-CEP 2014-196 - Rev 01 | 2023/03/13 | Valid | Chemical | 2023/03/13 | Minor revision|CEP granted|13/03/2023; Renewal|CEP granted|07/04/2022; Minor revision|CEP granted|09/08/2021; Minor revision|CEP granted|27/01/2021; Minor revision|CEP granted|06/08/2020 |