| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 333 | Heparin sodium, For parenteral preparations | NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO., LTD. Nanjing CN | 100021124;100054143 | CEP 2005-070 - Rev 11 | 2025/02/05 | Valid | Chemical | 2025/12/04 | Monograph revision|Accepted - CEP remains valid|04/12/2025; Notification|CEP granted|05/02/2025; Monograph revision|Accepted - CEP remains valid|09/12/2024; Notification|CEP granted|20/02/2024; Minor revision|CEP granted|08/06/2023; Notification|CEP granted|05/12/2022; Notification|CEP granted|13/12/2021; Minor revision|CEP granted|05/01/2021 |
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| 1423 | Flutamide | FERMION OY Espoo FI | 100011508;100020280 | CEP 2002-134 - Rev 05 | 2025/02/05 | Valid | Chemical | 2025/02/05 | Administrative procedure|CEP granted|05/02/2025; Minor revision|CEP granted|22/01/2025; Minor revision|Accepted - CEP remains valid|03/12/2021 |
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| 1075 | Budesonide, Codes 201680 and 2016112 | STERLING S.p.A. Solomeo Di Corciano IT | 100024377;100033551 | CEP 2017-138 - Rev 04 | 2025/02/05 | Valid | Chemical | 2025/02/05 | Major revision|CEP granted|05/02/2025; Renewal|CEP granted|15/02/2024; Major revision|Abandoned|02/11/2023 |
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| 817 | Cyproheptadine hydrochloride 1.5-hydrate | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2014-049 - Rev 02 | 2025/02/05 | Valid | Chemical | 2025/02/05 | Minor revision|CEP granted|05/02/2025; Minor revision|CEP granted|25/01/2022; Renewal|CEP granted|09/07/2021; Minor revision|CEP granted|28/01/2021 |
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| 1132 | Methylthioninium chloride hydrate | ICROM S.R.L. Concorezzo IT | 100022464;100031145 | CEP 2022-296 - Rev 01 | 2025/02/05 | Valid | 18/12/2028 | Chemical | 2025/02/05 | Minor revision|CEP granted|05/02/2025; New application|CEP granted|18/12/2023 |
|
| 2600 | Olmesartan medoxomil | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2014-196 - Rev 02 | 2025/02/04 | Valid | Chemical | 2025/02/04 | Major revision|CEP granted|04/02/2025; Minor revision|CEP granted|13/03/2023; Renewal|CEP granted|07/04/2022; Minor revision|CEP granted|09/08/2021; Minor revision|CEP granted|27/01/2021; Minor revision|CEP granted|06/08/2020 |
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| 429 | Progesterone, Process B, non-micronised and micronised | HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO., LTD. Ezhou City CN | 100015482;100024200 | CEP 2018-166 - Rev 04 | 2025/02/04 | Valid | Chemical | 2025/02/04 | Renewal|CEP granted|04/02/2025; Minor revision|CEP granted|20/08/2024; Minor revision|CEP granted|09/04/2024; Notification|CEP granted|19/01/2024 |
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| 2331 | Rabeprazole sodium hydrate | KRKA, d.d., Novo mesto Novo mesto SI | 100000627;100009540 | CEP 2018-140 - Rev 02 | 2025/02/04 | Valid | Chemical | 2025/02/04 | Renewal|CEP granted|04/02/2025; Minor revision|CEP granted|17/10/2022 |
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| 272 | Doxycycline hyclate | YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. Yangzhou CN | 100023496;100032638 | CEP 2000-165 - Rev 08 | 2025/02/04 | Valid | Chemical | 2025/02/04 | Notification|CEP granted|04/02/2025; Notification|Accepted - CEP remains valid|17/07/2023; Minor revision|CEP granted|20/04/2022 |
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| 2591 | Celecoxib, Process II | JIANGXI SYNERGY PHARMACEUTICAL CO., LTD. Yichun CN | 100020812;100080065 | CEP 2024-468 - Rev 00 | 2025/02/04 | Valid | 04/02/2030 | Chemical | 2025/02/04 | New application|CEP granted|04/02/2025 | |
| 1322 | Fenofibrate | AALIDHRA PHARMACHEM PRIVATE LIMITED Nandesari IN | 100042480;100070177 | CEP 2023-157 - Rev 00 | 2025/02/04 | Valid | 04/02/2030 | Chemical | 2025/02/04 | New application|CEP granted|04/02/2025 | |
| 2857 | Trazodone hydrochloride | ARENE LIFE SCIENCES PRIVATE LIMITED Sangareddy IN | 100033956;100079880 | CEP 2022-052 - Rev 01 | 2025/02/04 | Valid | 17/01/2028 | Chemical | 2025/02/04 | Minor revision|CEP granted|04/02/2025; Minor revision|Accepted - CEP remains valid|04/10/2024; New application|CEP granted|17/01/2023 |
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| 2296 | Pantoprazole sodium sesquihydrate | SVR DRUGS PRIVATE LIMITED Tadi Village IN | 100049140;100082990 | CEP 2020-071 - Rev 02 | 2025/02/04 | Valid | 13/04/2027 | Chemical | 2025/02/04 | Minor revision|CEP granted|04/02/2025; Minor revision|CEP granted|20/11/2023; New application|CEP granted|13/04/2022 |
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| 335 | Hydrocortisone, Process II, Non-micronised and Micronised | ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Xianju CN | 100022759;100031459 | CEP 2024-440 - Rev 00 | 2025/02/04 | Valid | 04/02/2030 | Chemical | 2025/02/04 | New application|CEP granted|04/02/2025 | |
| 1756 | Lamotrigine | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2011-010 - Rev 05 | 2025/02/03 | Valid | Chemical | 2025/02/03 | Minor revision|CEP granted|03/02/2025; Minor revision|CEP granted|12/07/2024; Notification|CEP granted|19/06/2023; Minor revision|CEP granted|18/02/2022; Minor revision|CEP granted|06/04/2020 |
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| 1169 | Piperacillin monohydrate | FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT | 100015105;100057989 | CEP 2012-101 - Rev 05 | 2025/02/03 | Valid | Chemical | 2025/02/03 | Administrative procedure|CEP granted|03/02/2025; Minor revision|CEP granted|21/01/2025; Notification|CEP granted|20/03/2023; Minor revision|Accepted - CEP remains valid|26/08/2022; Major revision|CEP granted|21/04/2022; Minor revision|Rejected|21/12/2021; Monograph revision|CEP granted|23/04/2021 |
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| 2016 | Ondansetron hydrochloride dihydrate | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2006-279 - Rev 04 | 2025/02/03 | Valid | Chemical | 2025/02/03 | Minor revision|CEP granted|03/02/2025 | ||
| 1280 | Zolpidem tartrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2004-159 - Rev 05 | 2025/02/03 | Valid | Chemical | 2025/02/03 | Minor revision|CEP granted|03/02/2025; Notification|CEP granted|04/02/2022; Notification|Accepted - CEP remains valid|10/06/2021; Monograph revision|Accepted - CEP remains valid|11/06/2020 |
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| 227 | Lidocaine hydrochloride monohydrate | SWATI SPENTOSE PVT. LTD. Mumbai IN | 100021605;100052219 | CEP 2013-103 - Rev 04 | 2025/02/03 | Valid | Chemical | 2025/02/03 | Administrative procedure|CEP granted|03/02/2025; Minor revision|CEP granted|14/01/2025; Minor revision|CEP granted|09/10/2024; Minor revision|CEP granted|10/05/2023 |
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| 2630 | Rivastigmine hydrogen tartrate | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2013-069 - Rev 01 | 2025/02/03 | Valid | Chemical | 2025/02/03 | Minor revision|CEP granted|03/02/2025 |
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