| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1696 | Flunixin meglumine for veterinary use, Process II | ZHEJIANG HISOAR PHARMACEUTICAL CO., LTD. Taizhou CN | 100011830;100018613 | CEP 2016-133 - Rev 01 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; Notification|Accepted - CEP remains valid|20/10/2022; Renewal|CEP granted|14/04/2022 |
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| 2777 | Pregabalin | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2016-220 - Rev 01 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; Minor revision|Accepted - CEP remains valid|03/07/2024; Notification|Accepted - CEP remains valid|04/08/2023; Minor revision|Accepted - CEP remains valid|15/03/2023; Renewal|CEP granted|13/06/2022 |
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| 3087 | Ticagrelor | DIVI'S LABORATORIES LIMITED Hyderabad IN | 100011666;100052116 | CEP 2022-072 - Rev 01 | 2026/02/16 | Valid | 24/10/2028 | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; New application|CEP granted|25/10/2023 |
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| 928 | Lomustine | UMICORE ARGENTINA S.A. Buenos Aires AR | 100022008;100030708 | CEP 2021-132 - Rev 01 | 2026/02/16 | Valid | 10/11/2027 | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; New application|CEP granted|10/11/2022 |
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| 1332 | Isoprenaline hydrochloride | WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi CN | 100022200;100030902 | CEP 2024-485 - Rev 00 | 2026/02/16 | Valid | 16/02/2031 | Chemical | 2026/02/16 | New application|CEP granted|16/02/2026 | |
| 140 | Ethinylestradiol, Micronised, non-micronised | ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN | 100022759;100031459 | CEP 2020-326 - Rev 01 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Renewal|CEP granted|16/02/2026; New application|CEP granted|26/04/2021 |
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| 20 | Dextromethorphan hydrobromide monohydrate | EXEMED PHARMACEUTICALS Vadodara IN | 100019154;100027915 | CEP 2021-257 - Rev 01 | 2026/02/16 | Valid | 20/12/2028 | Chemical | 2026/02/16 | Monograph revision|CEP granted|16/02/2026; New application|CEP granted|20/12/2023 |
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| 1694 | Gemfibrozil | ZHEJIANG EXCEL PHARMACEUTICAL CO., LTD. Taizhou CN | 100012381;100021159 | CEP 2008-118 - Rev 02 | 2026/02/13 | Valid | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; Minor revision|CEP granted|20/09/2021 |
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| 996 | Clindamycin phosphate | XINYU PHARMACEUTICAL CO., LTD. Suzhou CN | 100020532;100056331 | CEP 2011-019 - Rev 03 | 2026/02/13 | Valid | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; Minor revision|CEP granted|27/11/2024 |
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| 2541 | Quetiapine Fumarate | SYNTHIMED LABS PRIVATE LIMITED Derabassi IN | 100052287;100092080 | CEP 2015-178 - Rev 02 | 2026/02/13 | Valid | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; Minor revision|CEP granted|02/09/2024; Minor revision|Accepted - CEP remains valid|25/10/2023; Renewal|CEP granted|19/07/2021 |
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| 929 | Loperamide hydrochloride | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2013-333 - Rev 04 | 2026/02/13 | Valid | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; Minor revision|CEP granted|11/03/2024; Notification|CEP granted|30/01/2023; Minor revision|CEP granted|02/03/2022; Renewal|CEP granted|06/01/2021 |
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| 2254 | Moxifloxacin hydrochloride, Monohydrate, micronised and non-micronised | MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN | 100014794;100023345 | CEP 2007-355 - Rev 06 | 2026/02/13 | Valid | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; Minor revision|CEP granted|02/08/2024; Administrative procedure|CEP granted|22/09/2021; Minor revision|Accepted - CEP remains valid|14/09/2021 |
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| 203 | Polymyxin B sulfate, Pyrogen-free | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN | 100016034;100024777 | CEP 2024-585 - Rev 00 | 2026/02/13 | Valid | 13/02/2031 | Chemical and TSE | 2026/02/13 | New application|CEP granted|13/02/2026 | |
| 2741 | Sulfadimethoxine | ANUH PHARMA LIMITED Mumbai IN | 100021566;100030259 | CEP 2024-522 - Rev 01 | 2026/02/13 | Valid | 04/12/2030 | Chemical | 2026/03/04 | Notification|Accepted - CEP remains valid|04/03/2026; Minor revision|CEP granted|13/02/2026; New application|CEP granted|04/12/2025 |
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| 2857 | Trazodone hydrochloride | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2022-396 - Rev 01 | 2026/02/13 | Valid | 28/02/2029 | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; New application|CEP granted|28/02/2024 |
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| 1674 | Mesna | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100099917 | CEP 2015-299 - Rev 02 | 2026/02/13 | Valid | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; Major revision|CEP granted|20/08/2024; Renewal|CEP granted|03/02/2022 |
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| 2787 | Esomeprazole magnesium dihydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2014-333 - Rev 04 | 2026/02/12 | Valid | Chemical | 2026/02/12 | Minor revision|CEP granted|12/02/2026; Notification|CEP granted|06/06/2025; Minor revision|CEP granted|08/01/2025; Notification|CEP granted|07/03/2023; Renewal|CEP granted|26/04/2022; Minor revision|CEP granted|11/03/2020 |
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| 890 | Clonazepam | CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN | 100018245;100028824 | CEP 2006-030 - Rev 04 | 2026/02/12 | Valid | Chemical | 2026/02/12 | Monograph revision|CEP granted|12/02/2026; Major revision|Accepted - CEP remains valid|30/09/2024; Notification|CEP granted|20/10/2023; Major revision|CEP granted|28/04/2023 |
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| 936 | Midazolam | WAVELENGTH ENTERPRISES LTD. Petah Tikva IL | 100018877;100092992 | CEP 2006-267 - Rev 09 | 2026/02/12 | Valid | Chemical | 2026/02/12 | Minor revision|CEP granted|12/02/2026; Notification|CEP granted|23/10/2024; Minor revision|CEP granted|05/03/2024; Minor revision|Accepted - CEP remains valid|02/01/2023; Minor revision|CEP granted|20/06/2022; Notification|CEP granted|09/07/2020 |
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| 2732 | Dienogest, Micronised | GEDEON RICHTER PLC. Budapest X HU | 100000640;100001653 | CEP 2020-023 - Rev 01 | 2026/02/12 | Valid | 03/05/2027 | Chemical | 2026/02/12 | Major revision|CEP granted|12/02/2026; New application|CEP granted|03/05/2022 |
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