| 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 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2021-036 - Rev 02 | 2025/03/05 | Valid | 16/06/2028 | Chemical | 2025/03/05 | Notification|CEP granted|05/03/2025; Minor revision|CEP granted|21/10/2024; New application|CEP granted|16/06/2023 |
|
| 2777 | Pregabalin, Process II | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2021-197 - Rev 03 | 2025/03/05 | Valid | 20/09/2026 | Chemical | 2025/11/17 | Minor revision|Accepted - CEP remains valid|17/11/2025; Minor revision|Accepted - CEP remains valid|21/07/2025; Minor revision|CEP granted|05/03/2025; Minor revision|CEP granted|03/05/2024; Minor revision|CEP granted|25/10/2023; Minor revision|Accepted - CEP remains valid|28/07/2022; New application|CEP granted|20/09/2021 |
|
| 937 | Minoxidil | ZHEJIANG CDMO PHARMACEUTICAL CO., LTD Jinhua CN | 100051857;100091157 | CEP 2024-392 - Rev 00 | 2025/03/05 | Valid | 05/03/2030 | Chemical | 2025/04/14 | Minor revision|Accepted - CEP remains valid|14/04/2025; New application|CEP granted|05/03/2025 |
|
| 2631 | Rosuvastatin calcium, Process 4 | MOREPEN LABORATORIES LIMITED Baddi IN | 100017843;100026642 | CEP 2025-007 - Rev 00 | 2025/03/05 | Valid | 05/03/2030 | Chemical | 2025/03/05 | New application|CEP granted|05/03/2025 | |
| 1655 | Mitomycin | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2007-124 - Rev 05 | 2025/03/04 | Valid | Chemical | 2025/03/04 | Notification|CEP granted|04/03/2025; Minor revision|Accepted - CEP remains valid|02/03/2023; Notification|Rejected|03/02/2023; Notification|CEP granted|04/01/2022; Notification|Accepted - CEP remains valid|29/07/2020 |
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| 572 | Timolol maleate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1998-147 - Rev 12 | 2025/03/04 | Valid | Chemical | 2025/03/04 | Notification|CEP granted|04/03/2025; Minor revision|Accepted - CEP remains valid|02/07/2024; Notification|CEP granted|24/03/2022; Notification|CEP granted|20/12/2021; Minor revision|CEP granted|16/07/2021; Notification|Accepted - CEP remains valid|23/10/2020 |
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| 931 | Metformin Hydrochloride | WANBURY LIMITED Vashi, Navi Mumbai IN | 100021364;100030068 | CEP 1998-079 - Rev 12 | 2025/03/04 | Valid | Chemical | 2025/03/04 | Minor revision|CEP granted|04/03/2025; Minor revision|CEP granted|03/11/2023; Notification|Accepted - CEP remains valid|07/01/2022; Notification|CEP granted|10/08/2021 |
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| 2269 | Sevoflurane | SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN | 100025540;100034769 | CEP 2012-234 - Rev 01 | 2025/03/04 | Valid | Chemical | 2025/03/04 | Minor revision|CEP granted|04/03/2025; Notification|Accepted - CEP remains valid|28/08/2020 |
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| 2296 | Pantoprazole sodium sesquihydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2008-289 - Rev 05 | 2025/03/04 | Valid | Chemical | 2025/09/12 | Minor revision|Accepted - CEP remains valid|12/09/2025; Minor revision|CEP granted|04/03/2025; Minor revision|CEP granted|02/05/2024; Minor revision|Accepted - CEP remains valid|16/02/2023; Minor revision|CEP granted|21/04/2021 |
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| 2296 | Pantoprazole sodium sesquihydrate | ASSURGEN PHARMA PVT LTD Lalamkoduru Village IN | 100048048;100079469 | CEP 2018-199 - Rev 01 | 2025/03/04 | Valid | Chemical | 2025/03/04 | Renewal|CEP granted|04/03/2025 | ||
| 1788 | Methylergometrine maleate | TAPI CZECH INDUSTRIES S.R.O. Opava CZ | 100051642;100090678 | CEP 2012-405 - Rev 02 | 2025/03/04 | Valid | Chemical | 2025/03/04 | Notification|CEP granted|04/03/2025; Notification|Accepted - CEP remains valid|05/03/2024; Minor revision|Accepted - CEP remains valid|28/08/2023; Minor revision|CEP granted|12/09/2022 |
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| 2732 | Dienogest, Micronised | HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou City CN | 100015482;100024200 | CEP 2023-045 - Rev 01 | 2025/03/04 | Valid | 15/02/2029 | Chemical | 2025/03/04 | Minor revision|CEP granted|04/03/2025; New application|CEP granted|15/02/2024 |
|
| 2541 | Quetiapine Fumarate | IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN | 100017919;100037377 | CEP 2023-102 - Rev 00 | 2025/03/04 | Valid | 04/03/2030 | Chemical | 2025/03/04 | New application|CEP granted|04/03/2025 | |
| 735 | Prednisolone sodium phosphate | AVIK PHARMACEUTICAL LIMITED Vapi IN | 100023327;100041968 | CEP 2023-025 - Rev 00 | 2025/03/04 | Valid | 04/03/2030 | Chemical | 2025/03/04 | New application|CEP granted|04/03/2025 | |
| 1496 | Cassia oil, Rectified | FREY + LAU GMBH Henstedt-Ulzburg DE | 100017333;100026131 | CEP 2024-103 - Rev 00 | 2025/03/04 | Valid | 04/03/2030 | Herbal | 2025/03/04 | New application|CEP granted|04/03/2025 | |
| 2940 | Terpin monohydrate | DESTILERÍAS MUÑOZ GÁLVEZ, S.A. Murcia ES | 100022404;100031089 | CEP 2023-143 - Rev 00 | 2025/03/04 | Valid | 04/03/2030 | Chemical | 2025/03/04 | New application|CEP granted|04/03/2025 | |
| 3139 | Brivaracetam | YANGZHOU AURISCO PHARMACEUTICAL CO., LTD. Yangzhou City CN | 100048379;100080110 | CEP 2024-375 - Rev 00 | 2025/03/03 | Valid | 03/03/2030 | Chemical | 2025/03/03 | New application|CEP granted|03/03/2025 | |
| 1368 | Ramipril, Process 2 | ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN | 100022703;100031392 | CEP 2012-379 - Rev 02 | 2025/03/03 | Valid | Chemical | 2025/08/11 | Minor revision|Accepted - CEP remains valid|11/08/2025; Minor revision|CEP granted|03/03/2025; Minor revision|Accepted - CEP remains valid|18/03/2024; Minor revision|CEP granted|14/10/2022; Minor revision|Accepted - CEP remains valid|13/08/2021 |
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| 1450 | Mupirocin | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-317 - Rev 04 | 2025/03/03 | Valid | Chemical | 2025/03/03 | Notification|CEP granted|03/03/2025; Minor revision|Accepted - CEP remains valid|27/11/2023; Minor revision|CEP granted|05/11/2021 |
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| 1451 | Mupirocin calcium | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2008-158 - Rev 04 | 2025/02/28 | Valid | Chemical | 2025/02/28 | Notification|CEP granted|28/02/2025; Minor revision|CEP granted|01/04/2022 |
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