| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2131 | Tamsulosin hydrochloride | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2012-309 - Rev 03 | 2025/11/05 | Valid | Chemical | 2025/11/05 | Major revision|CEP granted|05/11/2025; Notification|CEP granted|15/12/2022; Minor revision|CEP granted|04/01/2022 |
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| 2465 | Irbesartan | CTX LIFESCIENCES PVT. LIMITED Surat IN | 100019102;100027863 | CEP 2011-139 - Rev 07 | 2025/11/05 | Valid | Chemical | 2025/11/05 | Administrative procedure|CEP granted|05/11/2025; Minor revision|CEP granted|24/10/2025; Major revision|CEP granted|16/06/2023; Minor revision|CEP granted|09/08/2021; Minor revision|CEP granted|11/12/2020 |
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| 549 | Dexamethasone sodium phosphate, Process II | TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN | 100011805;100018616 | CEP 2020-271 - Rev 01 | 2025/11/05 | Valid | 31/03/2027 | Chemical and TSE | 2025/11/05 | Minor revision|CEP granted|05/11/2025; New application|CEP granted|31/03/2022 |
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| 2358 | Teicoplanin | DONGKOOK PHARMACEUTICAL CO., LTD. Seoul KR | 100019576;100098744 | CEP 2009-335 - Rev 05 | 2025/11/05 | Valid | Chemical | 2025/11/05 | Notification|CEP granted|05/11/2025; Notification|CEP granted|19/10/2022; Notification|Accepted - CEP remains valid|14/09/2020 |
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| 354 | Prednisone | ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN | 100022759;100031459 | CEP 2018-027 - Rev 03 | 2025/11/05 | Valid | Chemical | 2025/11/05 | Minor revision|CEP granted|05/11/2025; Renewal|CEP granted|02/04/2024; Minor revision|CEP granted|18/03/2022; Notification|Accepted - CEP remains valid|06/08/2020 |
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| 2422 | Oseltamivir phosphate | BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO., LTD. Suzhou CN | 100011974;100021627 | CEP 2022-488 - Rev 01 | 2025/11/05 | Valid | 07/03/2029 | Chemical | 2025/11/05 | Minor revision|CEP granted|05/11/2025; New application|CEP granted|07/03/2024 |
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| 3052 | Lercanidipine hydrochloride, Hemihydrate, Amorphous form | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2024-593 - Rev 00 | 2025/11/05 | Valid | 05/11/2030 | Chemical | 2025/11/05 | New application|CEP granted|05/11/2025 | |
| 2751 | Valaciclovir hydrochloride hydrate | ATUL BIOSCIENCE LIMITED Ambernath (East) IN | 100044514;100086818 | CEP 2024-401 - Rev 00 | 2025/11/03 | Valid | 03/11/2030 | Chemical | 2025/11/03 | New application|CEP granted|03/11/2025 | |
| 3132 | Mirabegron | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100078783 | CEP 2024-015 - Rev 00 | 2025/11/03 | Valid | 03/11/2030 | Chemical | 2025/11/03 | New application|CEP granted|03/11/2025 | |
| 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 |
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