| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 891 | Copovidone, K-value: 27.0-33.0 | HUANGSHAN BONSUN PHARMACEUTICALS CO., LTD. Huangshan CN | 100039134;100098152 | CEP 2019-199 - Rev 01 | 2025/10/30 | Valid | Chemical | 2025/10/30 | Renewal|CEP granted|30/10/2025 | ||
| 1032 | Omeprazole sodium | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2007-276 - Rev 04 | 2025/10/30 | Valid | Chemical | 2025/10/30 | Administrative procedure|CEP granted|30/10/2025; Minor revision|CEP granted|22/10/2025 |
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| 1589 | Doxylamine hydrogen succinate | UNION QUIMICO FARMACEUTICA, S.A Barcelona ES | 100000721;100001301 | CEP 2004-089 - Rev 07 | 2025/10/30 | Valid | Chemical | 2025/10/30 | Minor revision|CEP granted|30/10/2025; Notification|Accepted - CEP remains valid|04/11/2021; Minor revision|CEP granted|21/10/2020 |
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| 2992 | Lacosamide | DIVI'S LABORATORIES LIMITED Hyderabad IN | 100011666;100052116 | CEP 2020-437 - Rev 03 | 2025/10/30 | Valid | 09/05/2027 | Chemical | 2025/10/30 | Minor revision|CEP granted|30/10/2025; Notification|Rejected|01/10/2025; Minor revision|CEP granted|27/07/2023; Administrative procedure|CEP granted|23/05/2022; New application|CEP granted|10/05/2022 |
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| 2303 | Adrenaline, Site-II | TRANSO-PHARM HANDELS GMBH Siek DE | 100018331;100027110 | CEP 2025-397 - Rev 00 | 2025/10/30 | Valid | 30/10/2030 | Chemical | 2025/10/30 | New application|CEP granted|30/10/2025 | |
| 254 | Adrenaline tartrate, Site-II | TRANSO-PHARM HANDELS GMBH Siek DE | 100018331;100027110 | CEP 2025-442 - Rev 00 | 2025/10/30 | Valid | 30/10/2030 | Chemical | 2025/10/30 | New application|CEP granted|30/10/2025 | |
| 3087 | Ticagrelor | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2023-368 - Rev 00 | 2025/10/30 | Valid | 30/10/2030 | Chemical | 2025/10/30 | New application|CEP granted|30/10/2025 | |
| 3095 | Dabigatran etexilate mesilate, Form-I | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2024-004 - Rev 01 | 2025/10/30 | Valid | 25/04/2030 | Chemical | 2025/10/30 | Minor revision|CEP granted|30/10/2025; New application|CEP granted|25/04/2025 |
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| 2574 | Entacapone | FERMION OY Espoo FI | 100011508;100020280 | CEP 2021-156 - Rev 01 | 2025/10/30 | Valid | 29/06/2028 | Chemical | 2025/10/30 | Minor revision|CEP granted|30/10/2025; New application|CEP granted|30/06/2023 |
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| 1720 | Enilconazole for veterinary use, By crystallization | AUDEVARD Clichy FR | 100014137;100062693 | CEP 2022-261 - Rev 01 | 2025/10/30 | Valid | 06/10/2027 | Chemical | 2025/10/30 | Minor revision|CEP granted|30/10/2025; New application|CEP granted|06/10/2022 |
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| 749 | Vincristine sulfate | HUBEI HONCH PHARMACEUTICAL CO., LTD. Huanggang CN | 100036821;100058182 | CEP 2024-264 - Rev 00 | 2025/10/30 | Valid | 30/10/2030 | Chemical | 2025/10/30 | New application|CEP granted|30/10/2025 | |
| 1796 | Sucralfate | ZHEJIANG HAISEN PHARMACEUTICAL CO., LTD. Xiangtan Village CN | 100024637;100033815 | CEP 2019-185 - Rev 02 | 2025/10/30 | Valid | Chemical | 2025/10/30 | Renewal|CEP granted|30/10/2025; Minor revision|Accepted - CEP remains valid|16/01/2025; Minor revision|CEP granted|18/08/2023 |
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| 1448 | Metoprolol succinate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2005-221 - Rev 07 | 2025/10/28 | Valid | Chemical | 2025/10/28 | Notification|CEP granted|28/10/2025; Notification|CEP granted|16/07/2025; Minor revision|Accepted - CEP remains valid|08/12/2023; Minor revision|Accepted - CEP remains valid|21/11/2022; Notification|CEP granted|21/12/2021; Minor revision|CEP granted|14/10/2020 |
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| 1488 | Alprostadil | EVERLIGHT CHEMICAL INDUSTRIAL CORPORATION Taipei TW | 100011679;100020963 | CEP 2012-204 - Rev 02 | 2025/10/28 | Valid | Chemical | 2025/10/28 | Minor revision|CEP granted|28/10/2025; Minor revision|CEP granted|27/06/2022 |
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| 2600 | Olmesartan medoxomil | VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100040217;100065484 | CEP 2023-253 - Rev 00 | 2025/10/28 | Valid | 28/10/2030 | Chemical | 2025/10/28 | New application|CEP granted|28/10/2025 | |
| 199 | Oxytetracycline dihydrate | CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. Castanheira do Ribatejo PT | 100021412;100078598 | CEP 2024-247 - Rev 00 | 2025/10/28 | Valid | 28/10/2030 | Chemical | 2025/10/28 | New application|CEP granted|28/10/2025 | |
| 1665 | Betahistine dihydrochloride | Grunenthal GmbH Aachen DE | 100000515;100006949 | CEP 2009-001 - Rev 03 | 2025/10/28 | Valid | Chemical | 2025/10/28 | Minor revision|CEP granted|28/10/2025; Minor revision|CEP granted|10/04/2025; Minor revision|Accepted - CEP remains valid|02/10/2024; Minor revision|Accepted - CEP remains valid|03/01/2023; Notification|Accepted - CEP remains valid|14/02/2022 |
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| 369 | Azathioprine | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2023-399 - Rev 00 | 2025/10/28 | Valid | 28/10/2030 | Chemical | 2025/10/28 | New application|CEP granted|28/10/2025 | |
| 2119 | Venlafaxine hydrochloride | ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO., LTD. Dongyang City CN | 100022699;100078733 | CEP 2023-219 - Rev 00 | 2025/10/28 | Valid | 28/10/2030 | Chemical | 2026/02/27 | Minor revision|Accepted - CEP remains valid|27/02/2026; New application|CEP granted|28/10/2025 |
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| 2234 | Meropenem trihydrate, Sterile, synthetic origin, process II | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2018-268 - Rev 02 | 2025/10/28 | Valid | Chemical | 2025/10/28 | Renewal|CEP granted|28/10/2025; Minor revision|CEP granted|19/12/2022 |
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