| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1075 | Budesonide | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2019-266 - Rev 01 | 2025/03/10 | Valid | 09/03/2027 | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025 | |
| 2858 | Mometasone furoate monohydrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2022-287 - Rev 02 | 2025/03/10 | Valid | 20/02/2028 | Chemical | 2025/03/10 | Notification|CEP granted|10/03/2025; Administrative procedure|CEP granted|07/03/2023; New application|CEP granted|20/02/2023 |
|
| 1593 | Megestrol acetate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2009-086 - Rev 02 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Notification|CEP granted|06/03/2025; Minor revision|Accepted - CEP remains valid|17/10/2024; Minor revision|Accepted - CEP remains valid|23/09/2022; Minor revision|CEP granted|17/12/2021 |
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| 1237 | Maprotiline hydrochloride | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2006-290 - Rev 09 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Minor revision|CEP granted|06/03/2025; Minor revision|CEP granted|21/08/2024; Minor revision|CEP granted|12/04/2024; Minor revision|CEP granted|21/03/2022 |
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| 96 | Mercaptopurine monohydrate | FERMION OY Espoo FI | 100011508;100020280 | CEP 2009-074 - Rev 04 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Monograph revision|CEP granted|06/03/2025; Notification|CEP granted|11/01/2021; Monograph revision|CEP granted|30/04/2020 |
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| 1752 | Ganciclovir, Anhydrous | EXCELLA GMBH & CO. KG Feucht DE | 100012030;100020739 | CEP 2010-257 - Rev 04 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Minor revision|CEP granted|06/03/2025; Minor revision|CEP granted|30/09/2021 |
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| 1750 | Fluticasone propionate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2005-209 - Rev 05 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Notification|CEP granted|06/03/2025; Minor revision|CEP granted|14/10/2024; Notification|CEP granted|23/11/2021; Monograph revision|CEP granted|10/06/2021 |
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| 2600 | Olmesartan medoxomil | ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN | 100012174;100018701 | CEP 2013-268 - Rev 03 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Minor revision|CEP granted|06/03/2025; Minor revision|Accepted - CEP remains valid|25/04/2024; Notification|Accepted - CEP remains valid|04/08/2023; Minor revision|Accepted - CEP remains valid|23/02/2023; Notification|Rejected|30/01/2023; Minor revision|CEP granted|07/01/2022; Minor revision|CEP granted|18/02/2021; Renewal|CEP granted|05/01/2021; Minor revision|Accepted - CEP remains valid|12/05/2020; Minor revision|Accepted - CEP remains valid|21/02/2020 |
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| 1324 | Flecainide acetate | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100022690 | CEP 2018-155 - Rev 05 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Renewal|CEP granted|06/03/2025; Administrative procedure|CEP granted|28/08/2024; Minor revision|CEP granted|14/08/2024; Minor revision|CEP granted|26/10/2023; Minor revision|CEP granted|19/05/2022 |
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| 2600 | Olmesartan medoxomil, Micronised and non-micronised | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | 100011732;100018657 | CEP 2012-070 - Rev 02 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Minor revision|CEP granted|06/03/2025; Minor revision|Accepted - CEP remains valid|24/02/2021 |
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| 2757 | Aprepitant | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2017-196 - Rev 03 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Notification|CEP granted|06/03/2025; Renewal|CEP granted|01/03/2024; Minor revision|CEP granted|17/07/2020 |
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| 2254 | Moxifloxacin hydrochloride | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2017-113 - Rev 02 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Minor revision|CEP granted|06/03/2025; Minor revision|CEP granted|27/11/2023; Renewal|CEP granted|02/03/2023; Minor revision|Accepted - CEP remains valid|30/04/2020 |
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| 260 | Amoxicillin trihydrate, Compacted | SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN | 100052070;100091614 | CEP 2024-539 - Rev 00 | 2025/03/06 | Valid | 06/03/2030 | Chemical | 2025/03/06 | New application|CEP granted|06/03/2025 | |
| 2932 | Rivaroxaban | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2021-318 - Rev 02 | 2025/03/06 | Valid | 10/05/2027 | Chemical | 2025/03/06 | Minor revision|CEP granted|06/03/2025; Minor revision|CEP granted|19/12/2022; New application|CEP granted|10/05/2022 |
|
| 2598 | Levofloxacin hemihydrate | ZHEJIANG LANGHUA PHARMACEUTICAL CO., LTD. Linhai CN | 100011848;100019493 | CEP 2019-111 - Rev 03 | 2025/03/06 | Valid | Chemical | 2025/03/06 | Renewal|CEP granted|06/03/2025; Minor revision|Accepted - CEP remains valid|07/10/2024; Minor revision|CEP granted|29/11/2023; Minor revision|Accepted - CEP remains valid|16/06/2023; Minor revision|CEP granted|26/09/2022 |
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| 1075 | Budesonide | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | 100016183;100024971 | CEP 2021-346 - Rev 01 | 2025/03/06 | Valid | 20/02/2028 | Chemical | 2025/03/06 | Minor revision|CEP granted|06/03/2025; New application|CEP granted|20/02/2023 |
|
| 260 | Amoxicillin trihydrate | SHANXI SHUANGYAN PHARMACEUTICAL CO., LTD. Datong CN | 100052070;100091614 | CEP 2024-422 - Rev 00 | 2025/03/06 | Valid | 06/03/2030 | Chemical | 2025/03/06 | New application|CEP granted|06/03/2025 | |
| 2531 | Clopidogrel hydrogen sulfate | ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100033956;100079880 | CEP 2020-042 - Rev 03 | 2025/03/05 | Valid | Chemical | 2025/12/02 | Renewal|Accepted - CEP remains valid|02/12/2025; Minor revision|CEP granted|05/03/2025; Minor revision|CEP granted|16/02/2024; Administrative procedure|CEP granted|09/04/2021; New application|CEP granted|09/03/2021 |
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| 693 | Tretinoin, Type 2 | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2010-034 - Rev 02 | 2025/03/05 | Valid | Chemical | 2025/03/05 | Minor revision|CEP granted|05/03/2025; Notification|Accepted - CEP remains valid|03/08/2022; Minor revision|CEP granted|02/07/2021; Major revision|Accepted - CEP remains valid|09/04/2020 |
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| 2423 | Valsartan, Process-II | ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN | 100012174;100018701 | CEP 2020-389 - Rev 04 | 2025/03/05 | Valid | 16/04/2026 | Chemical | 2025/03/05 | Notification|CEP granted|05/03/2025; Notification|Accepted - CEP remains valid|29/04/2024; Minor revision|Accepted - CEP remains valid|04/12/2023; Notification|Rejected|03/11/2023; Minor revision|CEP granted|28/06/2023; Notification|Accepted - CEP remains valid|26/01/2023; Major revision|CEP granted|30/06/2022; Minor revision|CEP granted|30/06/2021; New application|CEP granted|16/04/2021 |
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