| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 3139 | Brivaracetam, Non-micronised and micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2024-064 - Rev 02 | 2026/02/18 | Valid | 25/02/2030 | Chemical | 2026/02/18 | Minor revision|CEP granted|18/02/2026; Minor revision|CEP granted|04/12/2025; New application|CEP granted|25/02/2025 |
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| 2778 | Sitagliptin phosphate monohydrate | QUIMICA SINTETICA S.A. Alcala De Henares ES | 100012121;100019020 | CEP 2024-564 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 1449 | Mometasone furoate, Micronised and non-micronised | BREATHGREEN PHARMACEUTICAL CO. LTD. Zaozhuang CN | 100048781;100081153 | CEP 2025-361 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 2932 | Rivaroxaban | DIJIA PHARMACEUTICAL GROUP CO., LTD. Weihai CN | 100048717;100100668 | CEP 2024-174 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 1909 | Sodium polystyrene sulfonate | VALENS PHARMACHEM PRIVATE LIMITED Nadiad IN | 100052857;100093188 | CEP 2025-058 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 572 | Timolol maleate | TIANJIN MINXIANG PHARMACEUTICAL CO., LTD. Jinghai CN | 100034356;100054454 | CEP 2024-458 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 2631 | Rosuvastatin calcium, Process I | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2015-114 - Rev 04 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; Minor revision|CEP granted|21/10/2024; Notification|Accepted - CEP remains valid|20/03/2023; Major revision|CEP granted|27/01/2023; Major revision|CEP granted|22/02/2022; Renewal|CEP granted|16/08/2021; Monograph revision|CEP granted|13/08/2020 |
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| 2154 | Telmisartan, Non-micronised, micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2009-077 - Rev 03 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; Notification|Accepted - CEP remains valid|04/03/2025; Notification|Accepted - CEP remains valid|12/06/2024; Minor revision|Accepted - CEP remains valid|05/04/2023; Notification|Accepted - CEP remains valid|09/06/2022; Notification|Accepted - CEP remains valid|20/10/2021; Notification|CEP granted|14/04/2021; Major revision|Abandoned|23/02/2021; Minor revision|Accepted - CEP remains valid|23/10/2020 |
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| 53 | Streptomycin sulfate | North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN | 100021261;100029965 | CEP 2001-394 - Rev 04 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Monograph revision|CEP granted|16/02/2026; Minor revision|Accepted - CEP remains valid|22/07/2024; Minor revision|CEP granted|29/06/2023; Minor revision|CEP granted|27/08/2021; Monograph revision|Accepted - CEP remains valid|12/01/2021 |
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| 2531 | Clopidogrel hydrogen sulfate, Form II, micronised and non-micronised | MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN | 100012074;100018617 | CEP 2015-331 - Rev 01 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; Minor revision|Accepted - CEP remains valid|11/08/2022; Renewal|CEP granted|26/01/2022; Minor revision|CEP granted|01/12/2020 |
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| 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 |
|
| 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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