| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 931 | Metformin Hydrochloride, Process 2 | SHANDONG SHOUGUANG BOKANG PHARMACEUTICAL CO., LTD. Yangkou Town CN | 100048458;100080267 | CEP 2022-495 - Rev 01 | 2025/10/31 | Valid | 09/03/2028 | Chemical | 2025/10/31 | Minor revision|CEP granted|31/10/2025; New application|CEP granted|09/03/2023 |
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| 2535 | Levetiracetam | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2021-034 - Rev 01 | 2025/10/31 | Valid | 12/10/2027 | Chemical | 2025/10/31 | Minor revision|CEP granted|31/10/2025; Minor revision|Accepted - CEP remains valid|04/08/2023; New application|CEP granted|12/10/2022 |
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| 2531 | Clopidogrel hydrogen sulfate, Form II | ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO., LTD. Dongyang City CN | 100022699;100078733 | CEP 2020-165 - Rev 02 | 2025/10/31 | Valid | Chemical | 2025/10/31 | Renewal|CEP granted|31/10/2025; Minor revision|CEP granted|06/07/2021; New application|CEP granted|16/12/2020 |
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| 2856 | Pirfenidone | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2018-096 - Rev 01 | 2025/10/31 | Valid | Chemical | 2025/10/31 | Renewal|CEP granted|31/10/2025; Notification|Accepted - CEP remains valid|26/04/2022 |
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| 1425 | Fosfomycin trometamol, FT23 | LABIANA PHARMACEUTICALS, S.L.U. Corbera de Llobregat ES | 100000356;100010380 | CEP 2023-068 - Rev 02 | 2025/10/31 | Valid | 19/06/2028 | Chemical | 2025/10/31 | Minor revision|CEP granted|31/10/2025; Notification|CEP granted|04/03/2024; New application|CEP granted|19/06/2023 |
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| 2372 | Esomeprazole magnesium trihydrate, Micronised | SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO., LTD. Shenze CN | 100047734;100078894 | CEP 2024-211 - Rev 00 | 2025/10/31 | Valid | 31/10/2030 | Chemical | 2025/10/31 | New application|CEP granted|31/10/2025 | |
| 1753 | Iopromide, 202008 | BAYER AG Leverkusen DE | 100000011;100001505 | CEP 2020-273 - Rev 01 | 2025/10/31 | Valid | Chemical | 2025/10/31 | Renewal|CEP granted|31/10/2025; Minor revision|Accepted - CEP remains valid|29/07/2025; Minor revision|Accepted - CEP remains valid|28/04/2022; New application|CEP granted|06/01/2021 |
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| 1611 | Diosmin | CHENGDU SHUXI PHARMACEUTICAL CO., LTD. Chengdu City CN | 100039379;100061999 | CEP 2016-202 - Rev 01 | 2025/10/31 | Valid | Chemical | 2025/10/31 | Major revision|CEP granted|31/10/2025; Renewal|CEP granted|13/09/2022 |
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| 335 | Hydrocortisone, Micronised | SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN | 100018972;100095999 | CEP 2018-054 - Rev 03 | 2025/10/30 | Valid | Chemical | 2025/10/30 | Minor revision|CEP granted|30/10/2025; Renewal|CEP granted|15/04/2024; Minor revision|Accepted - CEP remains valid|28/11/2022; Minor revision|CEP granted|31/08/2020 |
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| 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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| 1090 | Clobetasone butyrate, Micronised | SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN | 100018972;100095999 | CEP 2012-282 - Rev 01 | 2025/10/30 | Valid | Chemical | 2025/10/30 | Minor revision|CEP granted|30/10/2025; Notification|Accepted - CEP remains valid|01/03/2021; Notification|Accepted - CEP remains valid|14/12/2020 |
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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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