| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1764 | Rocuronium bromide, Process II | Farmhispania S.A. Montmeló ES | 100011645;100022190 | CEP 2023-131 - Rev 02 | 2025/01/21 | Valid | 23/06/2028 | Chemical | 2025/01/21 | Minor revision|CEP granted|21/01/2025; Minor revision|CEP granted|03/06/2024; New application|CEP granted|23/06/2023 |
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| 2735 | Gadobutrol monohydrate | VIWIT PHARMACEUTICAL CO. LTD Tengzhou CN | 100049012;100082223 | CEP 2023-442 - Rev 01 | 2025/01/21 | Valid | 14/01/2030 | Chemical | 2025/06/24 | Minor revision|Rejected|24/06/2025; Administrative procedure|CEP granted|21/01/2025; New application|CEP granted|14/01/2025 |
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| 2778 | Sitagliptin phosphate monohydrate, Route STP Process | MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN | 100018316;100070723 | CEP 2020-200 - Rev 01 | 2025/01/21 | Valid | 16/12/2025 | Chemical | 2025/01/21 | Minor revision|CEP granted|21/01/2025; New application|CEP granted|16/12/2020 |
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| 2600 | Olmesartan medoxomil | HEC PHARM CO., LTD. Yidu City CN | 100017619;100026390 | CEP 2016-032 - Rev 02 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Notification|CEP granted|20/01/2025; Minor revision|CEP granted|05/08/2024; Renewal|CEP granted|05/01/2022; Minor revision|CEP granted|14/05/2020 |
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| 2404 | Drospirenone, Process I micronised | GEDEON RICHTER PLC. Budapest HU | 100000640;100001653 | CEP 2024-461 - Rev 00 | 2025/01/20 | Valid | 20/01/2030 | Chemical | 2025/01/20 | New application|CEP granted|20/01/2025 | |
| 1300 | Cefuroxime axetil | PURE AND CURE HEALTHCARE PRIVATE LIMITED Punjab IN | 100045639;100075200 | CEP 2008-203 - Rev 02 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Notification|CEP granted|20/01/2025; Notification|CEP granted|10/01/2022 |
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| 2341 | Cefpodoxime proxetil | PURE AND CURE HEALTHCARE PRIVATE LIMITED Punjab IN | 100045639;100075200 | CEP 2011-165 - Rev 02 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Notification|CEP granted|20/01/2025; Transfer of holdership|CEP granted|13/12/2021 |
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| 934 | Metronidazole benzoate | ACHARYA CHEMICALS Dombivli (East) IN | 100023843;100094052 | CEP 2007-056 - Rev 04 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Minor revision|CEP granted|20/01/2025; Notification|Rejected|10/12/2024; Administrative procedure|CEP granted|05/04/2023 |
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| 2777 | Pregabalin | SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN | 100018880;100027661 | CEP 2018-169 - Rev 01 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Renewal|CEP granted|20/01/2025 | ||
| 1191 | Clozapine | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2021-110 - Rev 01 | 2025/01/20 | Valid | 08/07/2027 | Chemical | 2025/06/13 | Minor revision|Accepted - CEP remains valid|13/06/2025; Minor revision|CEP granted|20/01/2025; New application|CEP granted|08/07/2022 |
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| 1745 | Carvedilol | CTX LIFESCIENCES PVT. LIMITED Surat IN | 100019102;100027863 | CEP 2014-201 - Rev 02 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Minor revision|CEP granted|20/01/2025; Minor revision|CEP granted|05/04/2022; Renewal|CEP granted|18/06/2021 |
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| 2335 | Ropivacaine hydrochloride monohydrate | SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN | 100048410;100080174 | CEP 2023-148 - Rev 01 | 2025/01/20 | Valid | 25/09/2029 | Chemical | 2025/01/20 | Minor revision|CEP granted|20/01/2025; New application|CEP granted|25/09/2024 |
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| 752 | Alanine | AMINO GMBH Frellstedt DE | 100011599;100021107 | CEP 2013-157 - Rev 02 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Notification|CEP granted|20/01/2025; Minor revision|CEP granted|31/05/2023 |
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| 1188 | Cefixime | PURE AND CURE HEALTHCARE PRIVATE LIMITED Punjab IN | 100045639;100075200 | CEP 2009-005 - Rev 02 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Notification|CEP granted|20/01/2025; Transfer of holdership|CEP granted|13/01/2022 |
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| 578 | Ampicillin sodium, Sterile, Enzymatic route | SANDOZ GMBH Kundl AT | 100000546;100000450 | CEP 2024-480 - Rev 00 | 2025/01/20 | Valid | 20/01/2030 | Chemical | 2025/01/20 | New application|CEP granted|20/01/2025 | |
| 1089 | Ciprofloxacin | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN | 100022562;100093113 | CEP 2020-120 - Rev 03 | 2025/01/17 | Valid | 11/06/2026 | Chemical | 2025/01/17 | Minor revision|CEP granted|17/01/2025; Minor revision|CEP granted|03/07/2024; Minor revision|CEP granted|26/10/2022; New application|CEP granted|11/06/2021 |
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| 2232 | Losartan potassium | SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100038855;100091886 | CEP 2023-049 - Rev 00 | 2025/01/17 | Valid | 17/01/2030 | Chemical | 2025/01/17 | New application|CEP granted|17/01/2025 | |
| 1456 | Olive oil, refined, BXR EU refined olive oil | SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint-Laurent Blangy FR | 100018152;100094230 | CEP 2012-333 - Rev 01 | 2025/01/17 | Valid | Chemical | 2025/10/30 | Minor revision|Accepted - CEP remains valid|30/10/2025; Notification|CEP granted|17/01/2025; Minor revision|Accepted - CEP remains valid|27/08/2024; Minor revision|Accepted - CEP remains valid|09/03/2022; Minor revision|Accepted - CEP remains valid|06/07/2020 |
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| 335 | Hydrocortisone, Non-micronised, micronised | SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN | 100011788;100019607 | CEP 2019-176 - Rev 01 | 2025/01/17 | Valid | 06/10/2026 | Chemical | 2025/01/17 | Minor revision|CEP granted|17/01/2025; Notification|Accepted - CEP remains valid|24/06/2024 |
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| 2702 | Chlormadinone acetate, Micronised (grade 21), non-micronised | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2018-122 - Rev 04 | 2025/01/17 | Valid | Chemical | 2025/01/17 | Renewal|CEP granted|17/01/2025; Minor revision|CEP granted|07/09/2023; Minor revision|CEP granted|18/12/2020; Minor revision|CEP granted|13/05/2020 |
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