| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2617 | Aripiprazole | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2013-324 - Rev 02 | 2025/11/03 | Valid | Chemical | 2025/11/03 | Notification|CEP granted|03/11/2025; Minor revision|Accepted - CEP remains valid|30/04/2024; Notification|CEP granted|11/08/2022; Notification|Accepted - CEP remains valid|13/12/2021; Renewal|CEP granted|08/07/2021 |
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| 1425 | Fosfomycin trometamol | LABIANA PHARMACEUTICALS, S.L.U. Corbera de Llobregat ES | 100000356;100010380 | CEP 2012-265 - Rev 06 | 2025/11/03 | Valid | Chemical | 2025/11/03 | Minor revision|CEP granted|03/11/2025; Notification|Accepted - CEP remains valid|04/07/2025; Notification|CEP granted|27/02/2024; Administrative procedure|CEP granted|23/11/2023; Notification|CEP granted|24/10/2023; Notification|CEP granted|17/12/2021; Minor revision|CEP granted|18/10/2021; Minor revision|Accepted - CEP remains valid|07/04/2020 |
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| 2591 | Celecoxib, Micronised and non micronised | KEKULE PHARMA LIMITED Hyderabad IN | 100033239;100051871 | CEP 2023-274 - Rev 00 | 2025/11/03 | Valid | 03/11/2030 | Chemical | 2025/11/03 | New application|CEP granted|03/11/2025 | |
| 1491 | Amlodipine besilate, Micronised and non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2016-282 - Rev 01 | 2025/11/03 | Valid | Chemical | 2025/11/03 | Major revision|CEP granted|03/11/2025; Renewal|CEP granted|06/07/2023; Minor revision|Accepted - CEP remains valid|13/07/2022; Minor revision|Accepted - CEP remains valid|26/04/2021; Minor revision|CEP granted|14/05/2020 |
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| . | Bovine pericardial tissue | BRIDGEMED SOLUTIONS, INC. Irvine US | 100055072;100097778 | CEP 2020-257 - Rev 01 | 2025/11/03 | Valid | TSE | 2025/11/03 | Renewal|CEP granted|03/11/2025; New application|CEP granted|07/05/2021 |
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| 1373 | Testosterone | JIANGSU JIAERKE PHARMACEUTICALS GROUP CO., LTD. Changzhou CN | 100019383;100028149 | CEP 2023-439 - Rev 00 | 2025/11/03 | Valid | 03/11/2030 | Chemical | 2025/11/03 | New application|CEP granted|03/11/2025 | |
| 1611 | Diosmin, Process 2 | BIORESINE INTERNATIONALE Kenitra MA | 100015357;100092292 | CEP 2024-565 - Rev 00 | 2025/11/03 | Valid | 03/11/2030 | Chemical | 2025/11/03 | New application|CEP granted|03/11/2025 | |
| 2357 | Dydrogesterone, Micronised | MANKIND PHARMA LIMITED New Delhi IN | 100040218;100065486 | CEP 2024-196 - Rev 00 | 2025/11/03 | Valid | 03/11/2030 | Chemical | 2025/11/03 | New application|CEP granted|03/11/2025 | |
| 2232 | Losartan potassium, LB4 Process | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2019-224 - Rev 04 | 2025/11/03 | Valid | Chemical | 2025/11/03 | Renewal|CEP granted|03/11/2025; Minor revision|Accepted - CEP remains valid|10/12/2024; Minor revision|CEP granted|12/01/2023; Administrative procedure|CEP granted|15/12/2021; Major revision|CEP granted|03/12/2021; Minor revision|Abandoned|30/09/2021 |
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| 2849 | Hydroxychloroquine sulfate | WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi City CN | 100022200;100030902 | CEP 2023-088 - Rev 00 | 2025/11/03 | Valid | 03/11/2030 | Chemical | 2025/11/03 | New application|CEP granted|03/11/2025 | |
| 3115 | Levocetirizine dihydrochloride, Process-2, Symed Labs Limited Unit-II, 2LCR | SYMED LABS LIMITED Hyderabad IN | 100018727;100090820 | CEP 2025-384 - Rev 00 | 2025/11/03 | Valid | 03/11/2030 | Chemical | 2025/11/03 | New application|CEP granted|03/11/2025 | |
| 721 | Ibuprofen | ZHEJIANG NHU COMPANY LTD. Shaoxing City CN | 100047413;100085979 | CEP 2022-354 - Rev 01 | 2025/11/03 | Valid | 07/02/2029 | Chemical | 2025/11/03 | Minor revision|CEP granted|03/11/2025; New application|CEP granted|07/02/2024 |
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| 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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