| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2191 | Atorvastatin calcium, Site 2 | ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN | 100049395;100084081 | CEP 2023-160 - Rev 01 | 2025/01/23 | Valid | 17/08/2028 | Chemical | 2025/08/22 | Major revision|Accepted - CEP remains valid|22/08/2025; Minor revision|CEP granted|23/01/2025; New application|CEP granted|17/08/2023 |
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| 599 | Cisplatin | VERANOVA, L.P. West Deptford US | 100012273;100018937 | CEP 2005-253 - Rev 02 | 2025/01/22 | Valid | Chemical | 2025/01/22 | Minor revision|CEP granted|22/01/2025; Notification|CEP granted|29/11/2023 |
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| 653 | Baclofen, Milled, sieved | EXCELLA GMBH & CO. KG Feucht DE | 100012030;100020739 | CEP 2007-238 - Rev 05 | 2025/01/22 | Valid | Chemical | 2025/01/22 | Monograph revision|CEP granted|22/01/2025; Minor revision|CEP granted|11/01/2024; Minor revision|CEP granted|16/11/2020; Minor revision|Accepted - CEP remains valid|24/02/2020 |
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| 888 | Ciprofloxacin Hydrochloride | BAYER AG Leverkusen DE | 100000011;100001505 | CEP 1998-103 - Rev 07 | 2025/01/22 | Valid | Chemical | 2025/01/22 | Minor revision|CEP granted|22/01/2025 | ||
| 548 | Dexamethasone acetate | EUROAPI FRANCE Vertolaye FR | 100039327;100061906 | CEP 1998-089 - Rev 08 | 2025/01/22 | Valid | Chemical | 2025/01/22 | Minor revision|CEP granted|22/01/2025; Transfer of holdership|CEP granted|16/12/2021 |
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| 560 | Methotrexate | FERMION OY Espoo FI | 100011508;100020280 | CEP 2001-145 - Rev 05 | 2025/01/22 | Valid | Chemical | 2025/10/01 | Notification|Accepted - CEP remains valid|01/10/2025; Minor revision|CEP granted|22/01/2025; Notification|Accepted - CEP remains valid|26/10/2022; Minor revision|Accepted - CEP remains valid|28/01/2022 |
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| 653 | Baclofen | COHANCE LIFESCIENCES LIMITED Hyderabad IN | 100011755;100021186 | CEP 2018-280 - Rev 02 | 2025/01/22 | Valid | 17/06/2026 | Chemical | 2025/01/22 | Minor revision|CEP granted|22/01/2025; Notification|CEP granted|15/12/2022 |
|
| 2333 | Fluvastatin sodium, Crystalline | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2018-182 - Rev 03 | 2025/01/22 | Valid | Chemical | 2025/01/22 | Minor revision|CEP granted|22/01/2025; Renewal|CEP granted|25/03/2024; Major revision|Rejected|20/09/2021; Minor revision|CEP granted|20/02/2020 |
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| 92 | Indometacin | CSPC OUYI PHARMACEUTICAL CO., LTD. Shijiazhuang CN | 100022915;100052600 | CEP 2008-004 - Rev 07 | 2025/01/22 | Valid | Chemical | 2025/03/04 | Minor revision|Accepted - CEP remains valid|04/03/2025; Minor revision|CEP granted|22/01/2025; Minor revision|Accepted - CEP remains valid|02/11/2021 |
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| 2779 | Solifenacin succinate, Micronised, non-micronised | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2016-131 - Rev 02 | 2025/01/22 | Valid | Chemical | 2025/06/02 | Major revision|Rejected|02/06/2025; Minor revision|CEP granted|22/01/2025; Minor revision|CEP granted|02/04/2024; Renewal|CEP granted|09/05/2022 |
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| 645 | Tobramycin | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2020-394 - Rev 02 | 2025/01/22 | Valid | 12/07/2027 | Chemical | 2025/01/22 | Minor revision|CEP granted|22/01/2025; Minor revision|Accepted - CEP remains valid|04/08/2023; Minor revision|CEP granted|02/02/2023; New application|CEP granted|12/07/2022 |
|
| 768 | Hydrocortisone hydrogen succinate | BIOFER SPA Milano IT | 100007069;100094164 | CEP 2019-039 - Rev 03 | 2025/01/22 | Valid | Chemical | 2025/01/22 | Renewal|CEP granted|22/01/2025; Major revision|CEP granted|21/04/2023; Notification|CEP granted|20/04/2022 |
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| 3087 | Ticagrelor, Form II, micronised | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2022-333 - Rev 01 | 2025/01/22 | Valid | 02/08/2029 | Chemical | 2025/01/22 | Minor revision|CEP granted|22/01/2025; New application|CEP granted|02/08/2024 |
|
| 678 | Sodium valproate, Process III | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2023-252 - Rev 01 | 2025/01/22 | Valid | 12/12/2028 | Chemical | 2025/01/22 | Minor revision|CEP granted|22/01/2025; New application|CEP granted|12/12/2023 |
|
| 3036 | Teriflunomide | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2023-313 - Rev 00 | 2025/01/22 | Valid | 22/01/2030 | Chemical | 2025/01/22 | New application|CEP granted|22/01/2025 | |
| 2779 | Solifenacin succinate, Process-II | OPTIMUS DRUGS PRIVATE LIMITED Hyderabad IN | 100020646;100092226 | CEP 2024-372 - Rev 00 | 2025/01/22 | Valid | 22/01/2030 | Chemical | 2025/01/22 | New application|CEP granted|22/01/2025 | |
| 1326 | Flumazenil | HUBEI HAOSUN PHARMACEUTICAL CO., LTD. Ezhou CN | 100012046;100019090 | CEP 2008-121 - Rev 03 | 2025/01/21 | Valid | Chemical | 2025/01/21 | Minor revision|CEP granted|21/01/2025; Minor revision|CEP granted|14/09/2023 |
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| 1767 | Tilidine hydrochloride hemihydrate | AREVIPHARMA GMBH Radebeul DE | 100011616;100022155 | CEP 2006-013 - Rev 03 | 2025/01/21 | Valid | Chemical | 2025/01/21 | Minor revision|CEP granted|21/01/2025; Monograph revision|CEP granted|15/10/2020 |
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| 1573 | Sumatriptan succinate | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2002-246 - Rev 10 | 2025/01/21 | Valid | Chemical | 2025/01/21 | Notification|CEP granted|21/01/2025; Minor revision|CEP granted|01/07/2024; Notification|CEP granted|23/05/2023 |
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| 902 | Ferrous fumarate | DR. PAUL LOHMANN GMBH & CO. KGAA Emmerthal DE | 100022728;100031429 | CEP 2004-232 - Rev 04 | 2025/01/21 | Valid | Chemical | 2025/01/21 | Minor revision|CEP granted|21/01/2025; Minor revision|Accepted - CEP remains valid|25/11/2021; Monograph revision|CEP granted|13/07/2021; Notification|CEP granted|27/02/2020 |
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