| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 926 | Levonorgestrel, Non-micronised and micronised | HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou City CN | 100015482;100024200 | CEP 2022-199 - Rev 01 | 2025/11/13 | Valid | 19/05/2028 | Chemical | 2025/11/13 | Minor revision|CEP granted|13/11/2025; New application|CEP granted|19/05/2023 |
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| 2223 | Glimepiride, Micronised | USV PRIVATE LIMITED Mumbai IN | 100006251;100010851 | CEP 2023-130 - Rev 01 | 2025/11/13 | Valid | 07/11/2028 | Chemical | 2025/11/13 | Minor revision|CEP granted|13/11/2025; New application|CEP granted|07/11/2023 |
|
| 2779 | Solifenacin succinate, Process II, form-I, micronised and non-micronised | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2025-401 - Rev 00 | 2025/11/13 | Valid | 13/11/2030 | Chemical | 2025/11/13 | New application|CEP granted|13/11/2025 | |
| 521 | Phenytoin sodium | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2016-038 - Rev 01 | 2025/11/13 | Valid | Chemical | 2025/11/13 | Minor revision|CEP granted|13/11/2025; Renewal|CEP granted|11/01/2023; Notification|CEP granted|01/03/2021; Minor revision|CEP granted|24/07/2020 |
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| 2127 | Clobetasol propionate, Micronised, non-micronised | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2011-135 - Rev 04 | 2025/11/13 | Valid | Chemical | 2025/11/13 | Major revision|CEP granted|13/11/2025; Administrative procedure|CEP granted|17/12/2021; Minor revision|CEP granted|10/12/2021; Monograph revision|Accepted - CEP remains valid|16/07/2020 |
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| 2736 | Imatinib mesilate, Form-β | ZHEJIANG AUSUN PHARMACEUTICAL CO., LTD. Taizhou CN | 100014719;100023221 | CEP 2023-303 - Rev 01 | 2025/11/12 | Valid | 05/03/2030 | Chemical | 2025/11/12 | Minor revision|CEP granted|12/11/2025; New application|CEP granted|05/03/2025 |
|
| 917 | Ichthammol, ICHTHYOL | OESTERREICHISCHE ICHTHYOL GES.M.B.H. & CO. KG Reith bei Seefeld AT | 100022779;100079288 | CEP 2025-374 - Rev 00 | 2025/11/12 | Valid | 12/11/2030 | Chemical | 2025/11/12 | New application|CEP granted|12/11/2025 | |
| 1751 | Fosinopril sodium | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2013-018 - Rev 03 | 2025/11/12 | Valid | Chemical | 2025/11/12 | Minor revision|CEP granted|12/11/2025; Notification|Accepted - CEP remains valid|14/10/2024; Minor revision|CEP granted|29/11/2023; Monograph revision|CEP granted|28/03/2022; Renewal|CEP granted|19/02/2021; Minor revision|CEP granted|25/08/2020 |
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| 2577 | Oxcarbazepine | ASSURGEN PHARMA PRIVATE LIMITED Lalamkoduru Village IN | 100048048;100079469 | CEP 2023-450 - Rev 00 | 2025/11/12 | Valid | 12/11/2030 | Chemical | 2025/11/12 | New application|CEP granted|12/11/2025 | |
| 546 | Chlortalidone | MENADIONA, S.L. Palafolls ES | 100015162;100023846 | CEP 2017-285 - Rev 02 | 2025/11/10 | Valid | Chemical | 2025/11/10 | Administrative procedure|CEP granted|10/11/2025; Renewal|CEP granted|05/03/2024; Monograph revision|Accepted - CEP remains valid|12/04/2022 |
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| 1649 | Azithromycin | ANUH PHARMA LTD. Mumbai IN | 100021566;100030259 | CEP 2021-143 - Rev 02 | 2025/11/10 | Valid | 13/07/2028 | Chemical | 2025/11/10 | Administrative procedure|CEP granted|10/11/2025; Minor revision|CEP granted|22/01/2025; New application|CEP granted|13/07/2023 |
|
| 1734 | Terbinafine hydrochloride | QUIMICA SINTETICA S.A. Alcala De Henares ES | 100012121;100019020 | CEP 2012-269 - Rev 02 | 2025/11/10 | Valid | Chemical | 2025/11/10 | Minor revision|CEP granted|10/11/2025 | ||
| 3137 | Dapagliflozin propylene glycol monohydrate | KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI | 100000627;100009540 | CEP 2025-193 - Rev 00 | 2025/11/10 | Valid | 10/11/2030 | Chemical | 2025/11/10 | New application|CEP granted|10/11/2025 | |
| 274 | Erythromycin ethylsuccinate, Powder, micronised | ERCROS S.A. Aranjuez ES | 100016091;100024873 | CEP 2002-136 - Rev 09 | 2025/11/10 | Valid | Chemical | 2025/11/10 | Administrative procedure|CEP granted|10/11/2025; Minor revision|CEP granted|02/12/2024 |
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| 179 | Erythromycin | ANUH PHARMA LTD. Mumbai IN | 100021566;100030259 | CEP 2005-205 - Rev 13 | 2025/11/10 | Valid | Chemical | 2025/11/10 | Administrative procedure|CEP granted|10/11/2025; Notification|CEP granted|08/07/2025; Notification|Accepted - CEP remains valid|23/12/2024; Notification|CEP granted|14/09/2023; Minor revision|CEP granted|10/08/2023; Minor revision|CEP granted|30/08/2022; Monograph revision|Accepted - CEP remains valid|22/02/2021; Notification|CEP granted|30/06/2020; Notification|CEP granted|26/02/2020 |
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| 227 | Lidocaine hydrochloride monohydrate | SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN | 100048410;100080174 | CEP 2024-340 - Rev 00 | 2025/11/10 | Valid | 10/11/2030 | Chemical | 2025/11/10 | New application|CEP granted|10/11/2025 | |
| 101 | Nitrofurantoin, Macrocrystals | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2019-092 - Rev 04 | 2025/11/10 | Valid | Chemical | 2025/11/10 | Minor revision|CEP granted|10/11/2025; Renewal|CEP granted|18/06/2025; Administrative procedure|CEP granted|12/10/2023; Minor revision|CEP granted|28/09/2023; Minor revision|Accepted - CEP remains valid|09/08/2023; Minor revision|Accepted - CEP remains valid|19/08/2021; Minor revision|Accepted - CEP remains valid|14/04/2021 |
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| 2423 | Valsartan, Essential Amorphous Form, Process-II | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2025-449 - Rev 00 | 2025/11/10 | Valid | 10/11/2030 | Chemical | 2025/11/10 | New application|CEP granted|10/11/2025 | |
| 193 | Sodium chloride | K+S MINERALS AND AGRICULTURE GMBH Kassel DE | 100020039;100051870 | CEP 2007-367 - Rev 04 | 2025/11/10 | Valid | Chemical | 2025/11/10 | Minor revision|CEP granted|10/11/2025; Minor revision|CEP granted|15/07/2024; Minor revision|Accepted - CEP remains valid|24/04/2023; Minor revision|Accepted - CEP remains valid|13/06/2022; Minor revision|Accepted - CEP remains valid|24/02/2021 |
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| 3049 | Etonogestrel | INDUSTRIALE CHIMICA S.R.L. Saronno IT | 100011692;100020331 | CEP 2025-195 - Rev 00 | 2025/11/10 | Valid | 10/11/2030 | Chemical | 2025/11/10 | New application|CEP granted|10/11/2025 |
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