| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2760 | Brimonidine tartrate | SYMED LABS LIMITED Hyderabad IN | 100018727;100090820 | CEP 2018-124 - Rev 01 | 2025/12/11 | Valid | Chemical | 2025/12/11 | Renewal|CEP granted|11/12/2025 | ||
| 2307 | Modafinil | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2014-073 - Rev 01 | 2025/12/11 | Valid | Chemical | 2025/12/11 | Minor revision|CEP granted|11/12/2025; Minor revision|Accepted - CEP remains valid|06/07/2022; Renewal|CEP granted|14/01/2021 |
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| 2064 | Chondroitin sulfate sodium, Process A and B | BIOIBERICA, S.A.U. Palafolls ES | 100000136;100043853 | CEP 2001-063 - Rev 07 | 2025/12/11 | Valid | TSE | 2025/12/11 | Minor revision|CEP granted|11/12/2025; Minor revision|CEP granted|26/10/2022; Major revision|CEP granted|24/03/2022 |
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| 1012 | Famotidine | GEDEON RICHTER PLC. Budapest HU | 100000640;100001653 | CEP 1999-054 - Rev 04 | 2025/12/11 | Valid | Chemical | 2025/12/11 | Minor revision|CEP granted|11/12/2025; Minor revision|CEP granted|18/02/2022 |
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| 601 | Dimenhydrinate | SHANGHAI WONDER PHARMACEUTICAL CO., LTD Shanghai CN | 100020697;100029440 | CEP 2020-110 - Rev 02 | 2025/12/11 | Valid | 03/03/2027 | Chemical | 2025/12/11 | Minor revision|CEP granted|11/12/2025; Notification|Accepted - CEP remains valid|07/07/2025; Minor revision|CEP granted|15/02/2024; New application|CEP granted|03/03/2022 |
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| 1648 | Thioctic acid | CADCHEM LABORATORIES LIMITED Chandigarh IN | 100039011;100083960 | CEP 2024-419 - Rev 00 | 2025/12/11 | Valid | 11/12/2030 | Chemical | 2025/12/11 | New application|CEP granted|11/12/2025 | |
| 1648 | Thioctic acid | KINSY S.L. Murcia ES | 100025606;100057039 | CEP 2024-321 - Rev 00 | 2025/12/11 | Valid | 11/12/2030 | Chemical | 2025/12/11 | New application|CEP granted|11/12/2025 | |
| 2445 | Adapalene | MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN | 100020971;100029680 | CEP 2023-462 - Rev 00 | 2025/12/11 | Valid | 11/12/2030 | Chemical | 2025/12/11 | New application|CEP granted|11/12/2025 | |
| 1699 | Mesalazine, Pubagang site | ZHEJIANG HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN | 100034135;100082085 | CEP 2021-400 - Rev 01 | 2025/12/10 | Valid | 17/12/2026 | Chemical | 2025/12/10 | Minor revision|CEP granted|10/12/2025; Minor revision|Accepted - CEP remains valid|04/10/2024; New application|CEP granted|17/12/2021 |
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| 2866 | Gefitinib, Micronised | SYNTHON B.V. Nijmegen NL | 100001342;100005475 | CEP 2016-154 - Rev 01 | 2025/12/10 | Valid | Chemical | 2025/12/10 | Minor revision|CEP granted|10/12/2025; Notification|Accepted - CEP remains valid|06/07/2022; Renewal|CEP granted|07/06/2022; Minor revision|Accepted - CEP remains valid|21/06/2021 |
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| 2127 | Clobetasol propionate | AVIK PHARMACEUTICAL LIMITED Vapi IN | 100023327;100041968 | CEP 2009-315 - Rev 03 | 2025/12/10 | Valid | Chemical | 2025/12/10 | Minor revision|CEP granted|10/12/2025; Notification|Accepted - CEP remains valid|13/09/2022; Monograph revision|CEP granted|04/06/2020 |
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| 1104 | Fluoxetine hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1997-042 - Rev 13 | 2025/12/10 | Valid | Chemical | 2025/12/10 | Notification|CEP granted|10/12/2025; Notification|CEP granted|12/03/2025; Notification|Accepted - CEP remains valid|02/12/2024; Minor revision|CEP granted|22/06/2023; Notification|Accepted - CEP remains valid|15/03/2022; Notification|CEP granted|20/12/2021; Monograph revision|CEP granted|28/01/2021 |
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| 2372 | Esomeprazole magnesium trihydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2014-286 - Rev 02 | 2025/12/10 | Valid | Chemical | 2025/12/10 | Minor revision|CEP granted|10/12/2025; Minor revision|CEP granted|21/07/2025; Renewal|CEP granted|16/03/2022; Minor revision|CEP granted|05/07/2021 |
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| 1103 | Fentanyl citrate | VERANOVA, L.P. West Deptford US | 100012273;100018937 | CEP 2005-104 - Rev 05 | 2025/12/10 | Valid | Chemical | 2025/12/10 | Notification|CEP granted|10/12/2025; Notification|CEP granted|30/08/2023; Minor revision|CEP granted|28/01/2022 |
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| 1075 | Budesonide, Micronised | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2024-441 - Rev 00 | 2025/12/10 | Valid | 10/12/2030 | Chemical | 2025/12/10 | New application|CEP granted|10/12/2025 | |
| 2280 | Fexofenadine hydrochloride | SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100038855;100091886 | CEP 2023-294 - Rev 00 | 2025/12/10 | Valid | 10/12/2030 | Chemical | 2025/12/10 | New application|CEP granted|10/12/2025 | |
| 1796 | Sucralfate | MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN | 100018316;100070723 | CEP 2024-342 - Rev 00 | 2025/12/10 | Valid | 10/12/2030 | Chemical | 2025/12/10 | New application|CEP granted|10/12/2025 | |
| 2422 | Oseltamivir phosphate, Crystal Form A | RUYUAN HEC PHARM CO., LTD. Shaoguan CN | 100023129;100031882 | CEP 2024-404 - Rev 00 | 2025/12/10 | Valid | 10/12/2030 | Chemical | 2025/12/10 | New application|CEP granted|10/12/2025 | |
| 2918 | Everolimus, 0.2% BHT | HISUN PHARMACEUTICAL (HANGZHOU) CO., LTD. Hangzhou City CN | 100012542;100060684 | CEP 2024-314 - Rev 00 | 2025/12/10 | Valid | 10/12/2030 | Chemical | 2025/12/10 | New application|CEP granted|10/12/2025 | |
| 2268 | Selamectin for veterinary use | LIVZON NEW NORTH RIVER PHARMACEUTICAL CO., LTD. Qingyuan City CN | 100020572;100029321 | CEP 2017-070 - Rev 01 | 2025/12/09 | Valid | Chemical | 2025/12/09 | Minor revision|CEP granted|09/12/2025; Minor revision|Accepted - CEP remains valid|29/10/2024; Renewal|CEP granted|02/05/2023; Minor revision|CEP granted|16/02/2021 |
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