| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2593 | Docetaxel | WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN | 100049301;100083738 | CEP 2022-011 - Rev 01 | 2026/01/16 | Valid | 25/01/2029 | Chemical | 2026/01/16 | Minor revision|CEP granted|16/01/2026; Notification|Rejected|15/01/2025; New application|CEP granted|25/01/2024 |
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| 2778 | Sitagliptin phosphate monohydrate | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2021-175 - Rev 01 | 2026/01/16 | Valid | 31/08/2028 | Chemical | 2026/01/16 | Notification|CEP granted|16/01/2026; New application|CEP granted|01/09/2023 |
|
| . | Foetal Bovine Serum | MEDIATECH INC. Manassas US | 100051460;100090205 | CEP 2018-271 - Rev 02 | 2026/01/16 | Valid | TSE | 2026/01/16 | Major revision|CEP granted|16/01/2026; Renewal|CEP granted|03/07/2024 |
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| 2296 | Pantoprazole sodium sesquihydrate, Form-I | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2023-210 - Rev 01 | 2026/01/16 | Valid | 10/04/2029 | Chemical | 2026/01/16 | Minor revision|CEP granted|16/01/2026; New application|CEP granted|10/04/2024 |
|
| 2932 | Rivaroxaban | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2021-178 - Rev 01 | 2026/01/16 | Valid | 05/06/2029 | Chemical | 2026/01/16 | Notification|CEP granted|16/01/2026; New application|CEP granted|05/06/2024 |
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| 685 | Povidone, K30 | SYNVENT NINGXIA CO.,LTD. Yinchuan CN | 100053713;100097301 | CEP 2025-305 - Rev 00 | 2026/01/16 | Valid | 16/01/2031 | Chemical | 2026/01/16 | New application|CEP granted|16/01/2026 | |
| 2465 | Irbesartan | SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100038855;100091886 | CEP 2023-330 - Rev 00 | 2026/01/16 | Valid | 16/01/2031 | Chemical | 2026/01/16 | New application|CEP granted|16/01/2026 | |
| 2888 | Rupatadine fumarate | TAGOOR LABORATORIES PRIVATE LIMITED Visakhapatnam IN | 100044712;100079990 | CEP 2025-343 - Rev 00 | 2026/01/16 | Valid | 16/01/2031 | Chemical | 2026/01/16 | New application|CEP granted|16/01/2026 | |
| 2097 | Mebeverine hydrochloride | SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100038855;100091886 | CEP 2023-409 - Rev 00 | 2026/01/16 | Valid | 16/01/2031 | Chemical | 2026/01/16 | New application|CEP granted|16/01/2026 | |
| 3132 | Mirabegron | VIWIT PHARMACEUTICAL CO. LTD Tengzhou CN | 100049012;100082223 | CEP 2024-039 - Rev 00 | 2026/01/16 | Valid | 16/01/2031 | Chemical | 2026/01/16 | New application|CEP granted|16/01/2026 | |
| 2932 | Rivaroxaban, Micronised | ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD. Jinhua City CN | 100024897;100034088 | CEP 2024-021 - Rev 00 | 2026/01/16 | Valid | 16/01/2031 | Chemical | 2026/01/16 | New application|CEP granted|16/01/2026 | |
| 2888 | Rupatadine fumarate | URQUIMA S.A. Palau-solità i Plegamans ES | 100004195;100003355 | CEP 2017-202 - Rev 01 | 2026/01/16 | Valid | Chemical | 2026/01/16 | Minor revision|CEP granted|16/01/2026; Renewal|CEP granted|09/08/2023; Minor revision|CEP granted|14/12/2022; Notification|Rejected|07/10/2022 |
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| 1708 | Azaperone for veterinary use | MENADIONA, S.L. Palafolls ES | 100015162;100023846 | CEP 2017-190 - Rev 02 | 2026/01/14 | Valid | Chemical | 2026/01/14 | Administrative procedure|CEP granted|14/01/2026; Renewal|CEP granted|28/03/2024 |
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| 1765 | Salmeterol xinafoate, Micronised, grades I and II | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2006-296 - Rev 06 | 2026/01/13 | Valid | Chemical | 2026/01/13 | Minor revision|CEP granted|13/01/2026; Notification|CEP granted|12/04/2022 |
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| 1275 | Ursodeoxycholic acid, UDCAe "c" | PharmaZell GmbH Raubling DE | 100012552;100021381 | CEP 2018-115 - Rev 02 | 2026/01/13 | Valid | Chemical and TSE | 2026/01/13 | Monograph revision|CEP granted|13/01/2026; Minor revision|CEP granted|17/06/2024; Renewal|CEP granted|10/08/2023; Minor revision|CEP granted|19/09/2022; Minor revision|Accepted - CEP remains valid|17/02/2022 |
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| 1593 | Megestrol acetate, Micronised and fine powder | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2002-181 - Rev 10 | 2026/01/13 | Valid | Chemical | 2026/01/13 | Minor revision|CEP granted|13/01/2026; Minor revision|Accepted - CEP remains valid|30/08/2024; Minor revision|CEP granted|30/05/2024; Administrative procedure|CEP granted|05/05/2022; Minor revision|CEP granted|14/04/2022; Minor revision|CEP granted|16/10/2020 |
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| 1444 | Macrogols, Type 300, 400, 600, 1000, 1500, 3000, 3350, 4000 and 6000 | CLARIANT PRODUKTE (DEUTSCHLAND) GMBH Frankfurt am Main DE | 100016585;100056036 | CEP 2002-180 - Rev 07 | 2026/01/13 | Valid | Chemical | 2026/01/13 | Minor revision|CEP granted|13/01/2026; Notification|CEP granted|04/11/2024; Minor revision|CEP granted|27/11/2023; Minor revision|CEP granted|23/11/2020 |
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| 2856 | Pirfenidone | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2018-091 - Rev 04 | 2026/01/13 | Valid | Chemical | 2026/01/13 | Notification|CEP granted|13/01/2026; Renewal|CEP granted|20/08/2024; Notification|CEP granted|23/08/2022 |
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| 2600 | Olmesartan medoxomil | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2013-325 - Rev 02 | 2026/01/13 | Valid | Chemical | 2026/01/13 | Notification|CEP granted|13/01/2026; Notification|CEP granted|12/08/2022; Renewal|CEP granted|18/12/2020 |
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| 1491 | Amlodipine besilate, Site Khazipally | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2023-064 - Rev 01 | 2026/01/13 | Valid | 31/05/2028 | Chemical | 2026/01/13 | Monograph revision|CEP granted|13/01/2026; New application|CEP granted|31/05/2023 |
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