| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 929 | Loperamide hydrochloride | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2013-333 - Rev 04 | 2026/02/13 | Valid | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; Minor revision|CEP granted|11/03/2024; Notification|CEP granted|30/01/2023; Minor revision|CEP granted|02/03/2022; Renewal|CEP granted|06/01/2021 |
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| 2254 | Moxifloxacin hydrochloride, Monohydrate, micronised and non-micronised | MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN | 100014794;100023345 | CEP 2007-355 - Rev 06 | 2026/02/13 | Valid | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; Minor revision|CEP granted|02/08/2024; Administrative procedure|CEP granted|22/09/2021; Minor revision|Accepted - CEP remains valid|14/09/2021 |
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| 203 | Polymyxin B sulfate, Pyrogen-free | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN | 100016034;100024777 | CEP 2024-585 - Rev 00 | 2026/02/13 | Valid | 13/02/2031 | Chemical and TSE | 2026/02/13 | New application|CEP granted|13/02/2026 | |
| 2741 | Sulfadimethoxine | ANUH PHARMA LIMITED Mumbai IN | 100021566;100030259 | CEP 2024-522 - Rev 01 | 2026/02/13 | Valid | 04/12/2030 | Chemical | 2026/03/04 | Notification|Accepted - CEP remains valid|04/03/2026; Minor revision|CEP granted|13/02/2026; New application|CEP granted|04/12/2025 |
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| 2857 | Trazodone hydrochloride | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2022-396 - Rev 01 | 2026/02/13 | Valid | 28/02/2029 | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; New application|CEP granted|28/02/2024 |
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| 1674 | Mesna | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100099917 | CEP 2015-299 - Rev 02 | 2026/02/13 | Valid | Chemical | 2026/02/13 | Minor revision|CEP granted|13/02/2026; Major revision|CEP granted|20/08/2024; Renewal|CEP granted|03/02/2022 |
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| 2787 | Esomeprazole magnesium dihydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2014-333 - Rev 04 | 2026/02/12 | Valid | Chemical | 2026/02/12 | Minor revision|CEP granted|12/02/2026; Notification|CEP granted|06/06/2025; Minor revision|CEP granted|08/01/2025; Notification|CEP granted|07/03/2023; Renewal|CEP granted|26/04/2022; Minor revision|CEP granted|11/03/2020 |
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| 890 | Clonazepam | CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN | 100018245;100028824 | CEP 2006-030 - Rev 04 | 2026/02/12 | Valid | Chemical | 2026/02/12 | Monograph revision|CEP granted|12/02/2026; Major revision|Accepted - CEP remains valid|30/09/2024; Notification|CEP granted|20/10/2023; Major revision|CEP granted|28/04/2023 |
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| 936 | Midazolam | WAVELENGTH ENTERPRISES LTD. Petah Tikva IL | 100018877;100092992 | CEP 2006-267 - Rev 09 | 2026/02/12 | Valid | Chemical | 2026/02/12 | Minor revision|CEP granted|12/02/2026; Notification|CEP granted|23/10/2024; Minor revision|CEP granted|05/03/2024; Minor revision|Accepted - CEP remains valid|02/01/2023; Minor revision|CEP granted|20/06/2022; Notification|CEP granted|09/07/2020 |
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| 2732 | Dienogest, Micronised | GEDEON RICHTER PLC. Budapest X HU | 100000640;100001653 | CEP 2020-023 - Rev 01 | 2026/02/12 | Valid | 03/05/2027 | Chemical | 2026/02/12 | Major revision|CEP granted|12/02/2026; New application|CEP granted|03/05/2022 |
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| 2777 | Pregabalin, Route code-PU, form-I, micronised, non-micronised, milled and non-milled | MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN | 100014794;100023345 | CEP 2015-337 - Rev 03 | 2026/02/12 | Valid | Chemical | 2026/02/12 | Minor revision|CEP granted|12/02/2026; Notification|CEP granted|25/10/2023; Minor revision|CEP granted|31/08/2022; Renewal|CEP granted|25/01/2022; Minor revision|CEP granted|21/04/2021 |
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| 2616 | Topiramate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2020-130 - Rev 02 | 2026/02/12 | Valid | 13/07/2027 | Chemical | 2026/02/12 | Minor revision|CEP granted|12/02/2026; Notification|CEP granted|06/03/2023; New application|CEP granted|13/07/2022 |
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| 1084 | Cetirizine dihydrochloride | INDOCO REMEDIES LIMITED Mumbai IN | 100020134;100061295 | CEP 2021-475 - Rev 01 | 2026/02/12 | Valid | 11/01/2028 | Chemical | 2026/02/12 | Minor revision|CEP granted|12/02/2026; New application|CEP granted|11/01/2023 |
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| 2591 | Celecoxib, Site Khazipally | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2023-194 - Rev 02 | 2026/02/12 | Valid | 16/08/2028 | Chemical | 2026/02/12 | Minor revision|CEP granted|12/02/2026; Minor revision|CEP granted|09/12/2025; New application|CEP granted|16/08/2023 |
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| 330 | Gelatin, Bovine acid hide | ROUSSELOT B.V. Son En Breugel NL | 100051434;100090148 | CEP 2020-357 - Rev 01 | 2026/02/12 | Valid | TSE | 2026/02/12 | Renewal|CEP granted|12/02/2026; New application|CEP granted|15/04/2021 |
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| 3137 | Dapagliflozin propylene glycol monohydrate, Micronised, non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2025-128 - Rev 00 | 2026/02/12 | Valid | 12/02/2031 | Chemical | 2026/02/12 | New application|CEP granted|12/02/2026 | |
| 1699 | Mesalazine | D. K. PHARMA CHEM PRIVATE LIMITED Badlapur IN | 100023552;100032697 | CEP 2025-039 - Rev 00 | 2026/02/12 | Valid | 12/02/2031 | Chemical | 2026/02/12 | New application|CEP granted|12/02/2026 | |
| 2931 | Sorafenib tosilate | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2024-167 - Rev 00 | 2026/02/12 | Valid | 12/02/2031 | Chemical | 2026/02/12 | New application|CEP granted|12/02/2026 | |
| 1425 | Fosfomycin trometamol | NANJING DORRA PHARMACEUTICAL TECHNOLOGY CO. LTD. Nanjing CN | 100041071;100087393 | CEP 2024-168 - Rev 01 | 2026/02/12 | Valid | 03/07/2030 | Chemical | 2026/02/12 | Minor revision|CEP granted|12/02/2026; New application|CEP granted|03/07/2025 |
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| 1519 | Flurbiprofen | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2003-154 - Rev 08 | 2026/02/11 | Valid | Chemical | 2026/02/11 | Administrative procedure|CEP granted|11/02/2026; Minor revision|CEP granted|02/02/2026; Monograph revision|CEP granted|14/04/2022; Minor revision|Rejected|12/10/2020 |
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