| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2932 | Rivaroxaban, Form I | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2021-045 - Rev 01 | 2025/03/14 | Valid | 23/06/2028 | Chemical | 2025/03/14 | Minor revision|CEP granted|14/03/2025; Minor revision|Accepted - CEP remains valid|20/10/2023; New application|CEP granted|23/06/2023 |
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| 922 | Ketoprofen, Process II | SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN | 100011774;100018647 | CEP 2024-496 - Rev 01 | 2025/03/14 | Valid | 10/01/2030 | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; New application|CEP granted|10/01/2025 |
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| 330 | Gelatin, Pig hide gelatin, partial alkaline hydrolysis, bloom value 220 g | WEIHAI YINHE BIOLOGICAL TECHNOLOGY CO., LTD. Weihai CN | 100050003;100087303 | CEP 2024-374 - Rev 00 | 2025/03/14 | Valid | 14/03/2030 | Chemical | 2025/03/14 | New application|CEP granted|14/03/2025 | |
| 922 | Ketoprofen | SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN | 100011774;100018647 | CEP 2021-457 - Rev 02 | 2025/03/14 | Valid | 05/12/2028 | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Monograph revision|CEP granted|15/11/2024; New application|CEP granted|05/12/2023 |
|
| 2127 | Clobetasol propionate, Micronised | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2007-066 - Rev 06 | 2025/03/12 | Valid | Chemical | 2025/03/12 | Notification|CEP granted|12/03/2025; Notification|Accepted - CEP remains valid|05/09/2023; Minor revision|CEP granted|18/05/2022; Notification|CEP granted|04/01/2022; Notification|Accepted - CEP remains valid|02/03/2021; Monograph revision|CEP granted|20/05/2020 |
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| 1350 | Nabumetone | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2000-115 - Rev 13 | 2025/03/12 | Valid | Chemical | 2025/09/03 | Minor revision|Accepted - CEP remains valid|03/09/2025; Notification|CEP granted|12/03/2025; Minor revision|CEP granted|02/08/2024; Notification|Accepted - CEP remains valid|17/03/2023; Notification|CEP granted|07/03/2022; Minor revision|CEP granted|14/06/2021 |
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| 29 | Imipramine hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2002-051 - Rev 05 | 2025/03/12 | Valid | Chemical | 2025/03/12 | Notification|CEP granted|12/03/2025; Minor revision|CEP granted|30/01/2024; Minor revision|CEP granted|24/02/2022; Notification|Accepted - CEP remains valid|14/12/2020 |
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| 2333 | Fluvastatin sodium | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-201 - Rev 03 | 2025/03/12 | Valid | Chemical | 2025/03/12 | Notification|CEP granted|12/03/2025; Major revision|CEP granted|05/05/2023; Notification|CEP granted|04/02/2022 |
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| 2465 | Irbesartan | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2011-251 - Rev 07 | 2025/03/12 | Valid | Chemical | 2025/07/24 | Notification|Accepted - CEP remains valid|24/07/2025; Notification|CEP granted|12/03/2025; Major revision|CEP granted|16/12/2024; Notification|CEP granted|17/06/2024; Minor revision|Accepted - CEP remains valid|17/02/2023; Minor revision|CEP granted|30/09/2021; Notification|CEP granted|03/03/2021; Major revision|CEP granted|30/07/2020 |
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| 2465 | Irbesartan | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-322 - Rev 03 | 2025/03/12 | Valid | Chemical | 2025/03/12 | Notification|CEP granted|12/03/2025; Notification|CEP granted|07/03/2022 |
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| 2583 | Montelukast sodium, ID 6177 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2017-131 - Rev 06 | 2025/03/12 | Valid | Chemical | 2025/08/05 | Notification|Accepted - CEP remains valid|05/08/2025; Notification|CEP granted|12/03/2025; Major revision|CEP granted|27/09/2024; Renewal|CEP granted|19/03/2024; Notification|CEP granted|23/03/2023; Minor revision|CEP granted|08/11/2021 |
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| 2531 | Clopidogrel hydrogen sulfate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2011-143 - Rev 04 | 2025/03/12 | Valid | Chemical | 2025/03/12 | Notification|CEP granted|12/03/2025; Notification|Accepted - CEP remains valid|10/07/2023; Notification|CEP granted|08/02/2022; Notification|CEP granted|30/06/2021; Minor revision|CEP granted|28/04/2020 |
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| 2600 | Olmesartan medoxomil, Process 2 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2020-325 - Rev 02 | 2025/03/12 | Valid | Chemical | 2025/11/24 | Renewal|Accepted - CEP remains valid|24/11/2025; Notification|CEP granted|12/03/2025; Notification|Accepted - CEP remains valid|17/01/2024; Notification|CEP granted|23/02/2022; New application|CEP granted|06/01/2021 |
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| 2232 | Losartan potassium, Process 2 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2021-227 - Rev 02 | 2025/03/12 | Valid | 17/11/2027 | Chemical | 2025/03/12 | Notification|CEP granted|12/03/2025; Notification|CEP granted|13/02/2023; New application|CEP granted|17/11/2022 |
|
| 2465 | Irbesartan, Process 2 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2022-046 - Rev 02 | 2025/03/12 | Valid | 20/10/2027 | Chemical | 2025/03/12 | Notification|CEP granted|12/03/2025; Notification|CEP granted|04/03/2024; New application|CEP granted|20/10/2022 |
|
| 896 | Deferoxamine mesilate, Produced by a synthetic process | EXCELLA GMBH & CO. KG Feucht DE | 100012030;100020739 | CEP 2009-401 - Rev 06 | 2025/03/11 | Valid | Chemical | 2025/03/11 | Minor revision|CEP granted|11/03/2025; Minor revision|CEP granted|25/10/2024; Minor revision|CEP granted|16/03/2023 |
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| 1046 | Tamoxifen citrate, Milled A; Milled Z | EXCELLA GMBH & CO. KG Feucht DE | 100012030;100020739 | CEP 2021-495 - Rev 03 | 2025/03/11 | Valid | 13/03/2028 | Chemical | 2025/03/11 | Minor revision|CEP granted|11/03/2025; Notification|CEP granted|28/10/2024; Major revision|CEP granted|06/07/2023; New application|CEP granted|13/03/2023 |
|
| 1331 | Glyceryl trinitrate solution | Dynamit Nobel GmbH, Explosivstoff- und Systemtechnik Leverkusen DE | 100011675;100020630 | CEP 2003-185 - Rev 02 | 2025/03/11 | Valid | Chemical | 2025/03/11 | Major revision|CEP granted|11/03/2025 | ||
| 464 | Amitriptyline hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2001-432 - Rev 06 | 2025/03/11 | Valid | Chemical | 2025/03/11 | Notification|CEP granted|11/03/2025; Minor revision|CEP granted|07/05/2024; Notification|Accepted - CEP remains valid|05/07/2023; Notification|Accepted - CEP remains valid|02/08/2022; Notification|CEP granted|04/02/2022; Minor revision|Accepted - CEP remains valid|12/10/2021; Notification|Rejected|16/08/2021 |
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| 994 | Ciclosporin | TAPI CZECH INDUSTRIES S.R.O. Opava CZ | 100051642;100090678 | CEP 2002-152 - Rev 07 | 2025/03/11 | Valid | Chemical | 2025/03/11 | Notification|CEP granted|11/03/2025; Minor revision|CEP granted|21/06/2023; Monograph revision|CEP granted|02/09/2021; Minor revision|Accepted - CEP remains valid|24/02/2020 |
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