| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 454 | Acetazolamide | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100099996 | CEP 2018-203 - Rev 03 | 2026/03/19 | Valid | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; Renewal|CEP granted|26/02/2025; Minor revision|CEP granted|27/11/2023; Minor revision|Accepted - CEP remains valid|13/01/2022 |
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| 931 | Metformin Hydrochloride, 2nd line | NINGXIA HENGKANG TECHNOLOGY CO., LTD. Yinchuan CN | 100049743;100086705 | CEP 2024-237 - Rev 03 | 2026/03/19 | Valid | 02/08/2029 | Chemical | 2026/03/19 | Major revision|CEP granted|19/03/2026; Major revision|CEP granted|14/08/2025; Minor revision|CEP granted|23/12/2024; New application|CEP granted|02/08/2024 |
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| 335 | Hydrocortisone | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | 100016183;100024971 | CEP 2022-264 - Rev 01 | 2026/03/19 | Valid | 22/08/2028 | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; New application|CEP granted|22/08/2023 |
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| 2254 | Moxifloxacin hydrochloride | HEC PHARM GMBH Berlin DE | 100002583;100098718 | CEP 2013-225 - Rev 04 | 2026/03/19 | Valid | Chemical | 2026/03/19 | Notification|CEP granted|19/03/2026; Administrative procedure|CEP granted|03/12/2024; Minor revision|CEP granted|05/08/2024; Minor revision|CEP granted|26/08/2021 |
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| . | Collagen | GUANGZHOU TRAUER BIOTECHNOLOGY CO., LTD. Guangzhou CN | 100055483;100098662 | CEP 2025-482 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | TSE | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 285 | Noradrenaline tartrate | MOEHS IBERICA S.L. Rubi ES | 100029092;100068825 | CEP 2024-532 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 3095 | Dabigatran etexilate mesilate, Form-I | PIRAMAL PHARMA LIMITED Digwal Village IN | 100036948;100058375 | CEP 2024-090 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 655 | Camphor, racemic | SAPTAGIR LABORATORIES PRIVATE LIMITED Hyderabad IN | 100042587;100070387 | CEP 2023-320 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 1386 | Albendazole | MAHI DRUGS PRIVATE LIMITED Hyderabad IN | 100048039;100079525 | CEP 2023-415 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 2217 | Lamivudine | SMS PHARMACEUTICALS LIMITED Hyderabad IN | 100011780;100061058 | CEP 2023-425 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 1467 | Prednicarbate | SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. Butterworth MY | 100014908;100053188 | CEP 2024-038 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 2589 | Abacavir sulfate | VIYASH LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100040217;100065484 | CEP 2025-454 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 2598 | Levofloxacin hemihydrate | SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN | 100011774;100018647 | CEP 2019-315 - Rev 02 | 2026/03/17 | Valid | 18/05/2027 | Chemical | 2026/03/19 | Minor revision|CEP granted|19/03/2026; Notification|CEP granted|14/03/2025; Minor revision|Accepted - CEP remains valid|28/05/2024; Minor revision|Accepted - CEP remains valid|12/06/2023 |
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| 2775 | Nebivolol hydrochloride | LUSOCHIMICA S.P.A. Casaletto Lodigiano IT | 100014864;100023519 | CEP 2023-063 - Rev 02 | 2026/03/17 | Valid | 03/04/2029 | Chemical | 2026/03/19 | Notification|CEP granted|19/03/2026; Notification|CEP granted|30/07/2024; New application|CEP granted|03/04/2024 |
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| 2287 | Fluconazole, Process II | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2009-226 - Rev 05 | 2026/03/17 | Valid | Chemical | 2026/03/19 | Monograph revision|CEP granted|19/03/2026; Notification|CEP granted|04/04/2025; Minor revision|CEP granted|09/01/2025; Notification|CEP granted|06/12/2022 |
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| 2215 | Iodixanol | ZHEJIANG HAIZHOU PHARMACEUTICAL CO., LTD. Linhai CN | 100023844;100033013 | CEP 2025-035 - Rev 00 | 2026/03/17 | Valid | 17/03/2031 | Chemical | 2026/03/19 | New application|CEP granted|19/03/2026 | |
| 1456 | Olive oil, refined, BXR EU refined olive oil | SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint Laurent Blangy FR | 100018152;100094230 | CEP 2012-333 - Rev 02 | 2026/03/13 | Valid | Chemical | 2026/03/13 | Administrative procedure|CEP granted|13/03/2026; Minor revision|Accepted - CEP remains valid|30/10/2025; Notification|CEP granted|17/01/2025; Minor revision|Accepted - CEP remains valid|27/08/2024; Minor revision|Accepted - CEP remains valid|09/03/2022; Minor revision|Accepted - CEP remains valid|06/07/2020 |
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| 2258 | Olanzapine | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2012-161 - Rev 05 | 2026/03/13 | Valid | Chemical | 2026/03/13 | Minor revision|CEP granted|13/03/2026; Minor revision|Accepted - CEP remains valid|30/04/2025; Notification|Rejected|15/04/2025; Notification|CEP granted|19/03/2025; Notification|CEP granted|15/04/2024; Minor revision|CEP granted|04/01/2022; Administrative procedure|CEP granted|12/08/2020; Notification|Abandoned|05/08/2020 |
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| 1409 | Clenbuterol Hydrochloride | CHEMISCH-PHARMAZEUTISCHES LABOR ROLF SACHSE GMBH Berlin DE | 100013251;100022210 | CEP 2019-287 - Rev 01 | 2026/03/13 | Valid | Chemical | 2026/03/13 | Renewal|CEP granted|13/03/2026 | ||
| 2988 | Fingolimod hydrochloride | SYNTHON B.V. Nijmegen NL | 100001342;100005475 | CEP 2020-220 - Rev 01 | 2026/03/13 | Valid | Chemical | 2026/03/13 | Renewal|CEP granted|13/03/2026; Monograph revision|Accepted - CEP remains valid|03/05/2024; Minor revision|Accepted - CEP remains valid|29/06/2022; New application|CEP granted|29/04/2021 |
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