| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2790 | Clopidogrel besilate, Process III | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2019-347 - Rev 02 | 2023/09/18 | Valid | 16/02/2027 | Chemical | 2023/09/18 | Major revision|CEP granted|18/09/2023; Notification|CEP granted|11/07/2022 |
|
| 911 | Histidine, SA | Ajinomoto Co., Inc. Tokyo JP | 100011941;100021464 | CEP 2014-269 - Rev 01 | 2023/09/15 | Valid | Chemical | 2023/09/15 | Notification|CEP granted|15/09/2023 | ||
| 2931 | Sorafenib tosilate, Form-III | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | 100011732;100023530 | CEP 2021-430 - Rev 01 | 2023/09/15 | Valid | 31/08/2028 | Chemical | 2023/09/15 | Administrative procedure|CEP granted|15/09/2023; New application|CEP granted|01/09/2023 |
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| 1094 | Cyproterone acetate, Process II | ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Xianju CN | 100022759;100031459 | CEP 2023-187 - Rev 00 | 2023/09/15 | Valid | 15/09/2028 | Chemical | 2023/09/15 | New application|CEP granted|15/09/2023 | |
| 1472 | Sodium hyaluronate, HA-EP 1.8 (intrinsic viscosity: 1.6-2.2 m3/kg); from fermentation; for parenteral administration including intra-articular administration and intra-ocular use | BLOOMAGE BIOTECHNOLOGY CORP., LTD. Jinan CN | 100024983;100034173 | CEP 2010-289 - Rev 04 | 2023/09/15 | Valid | Chemical | 2023/09/15 | Administrative procedure|CEP granted|15/09/2023; Notification|Accepted - CEP remains valid|29/03/2023; Notification|CEP granted|09/01/2023; Minor revision|CEP granted|18/12/2020 |
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| 2988 | Fingolimod hydrochloride | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2020-156 - Rev 02 | 2023/09/15 | Valid | 02/11/2026 | Chemical | 2024/04/25 | Monograph revision|Accepted - CEP remains valid|25/04/2024; Notification|CEP granted|15/09/2023; Minor revision|CEP granted|24/07/2023; Minor revision|Accepted - CEP remains valid|06/02/2023; New application|CEP granted|02/11/2021 |
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| 1326 | Flumazenil | HUBEI HAOSUN PHARMACEUTICAL CO., LTD. Ezhou CN | 100012046;100019090 | CEP 2008-121 - Rev 02 | 2023/09/14 | Valid | Chemical | 2023/09/14 | Minor revision|CEP granted|14/09/2023 | ||
| 2780 | Temozolomide | WAVELENGTH ENTERPRISES LTD. Petah Tikva IL | 100018877;100050444 | CEP 2020-426 - Rev 01 | 2023/09/14 | Valid | 12/05/2027 | Chemical | 2024/04/12 | Minor revision|Accepted - CEP remains valid|12/04/2024; Minor revision|CEP granted|14/09/2023; Notification|Accepted - CEP remains valid|14/06/2022; New application|CEP granted|13/05/2022 |
|
| 179 | Erythromycin | ANUH PHARMA LTD. Mumbai IN | 100021566;100030259 | CEP 2005-205 - Rev 11 | 2023/09/14 | Valid | Chemical | 2023/09/14 | Notification|CEP granted|14/09/2023; Minor revision|CEP granted|10/08/2023; Minor revision|CEP granted|30/08/2022; Monograph revision|Accepted - CEP remains valid|22/02/2021; Notification|CEP granted|30/06/2020; Notification|CEP granted|26/02/2020 |
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| 2932 | Rivaroxaban | SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN | 100018880;100027661 | CEP 2021-466 - Rev 01 | 2023/09/14 | Valid | 23/06/2028 | Chemical | 2023/09/14 | Minor revision|CEP granted|14/09/2023; New application|CEP granted|23/06/2023 |
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| 2126 | Cefepime dihydrochloride monohydrate, Sterile, process 2 | FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT | 100015105;100057989 | CEP 2022-460 - Rev 00 | 2023/09/13 | Valid | 13/09/2028 | Chemical | 2023/09/13 | New application|CEP granted|13/09/2023 | |
| 1765 | Salmeterol xinafoate | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2011-277 - Rev 03 | 2023/09/12 | Valid | Chemical | 2023/09/12 | Minor revision|CEP granted|12/09/2023; Notification|CEP granted|07/09/2021 |
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| 234 | Norethisterone | BAYER AG Leverkusen DE | 100000011;100001505 | CEP 2000-110 - Rev 05 | 2023/09/12 | Valid | Chemical | 2023/09/12 | Notification|CEP granted|12/09/2023 | ||
| 394 | Hydrochlorothiazide | Unichem Laboratories Limited Mumbai IN | 100005397;100000756 | CEP 2000-091 - Rev 06 | 2023/09/12 | Valid | Chemical | 2023/09/12 | Minor revision|CEP granted|12/09/2023; Minor revision|CEP granted|16/05/2023; Notification|Accepted - CEP remains valid|26/09/2022 |
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| 2577 | Oxcarbazepine | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2022-155 - Rev 00 | 2023/09/12 | Valid | 12/09/2028 | Chemical | 2023/09/12 | New application|CEP granted|12/09/2023 | |
| 2191 | Atorvastatin calcium, Form-I | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2011-222 - Rev 02 | 2023/09/11 | Valid | Chemical | 2023/09/11 | Minor revision|CEP granted|11/09/2023; Monograph revision|CEP granted|09/12/2022 |
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| 816 | Cinnarizine | FDC Limited Mumbai IN | 100011646;100021030 | CEP 2003-150 - Rev 03 | 2023/09/08 | Valid | Chemical | 2023/09/08 | Minor revision|CEP granted|08/09/2023; Minor revision|Accepted - CEP remains valid|21/07/2022 |
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| 2330 | Leflunomide | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100022645 | CEP 2018-269 - Rev 01 | 2023/09/08 | Valid | 01/04/2026 | Chemical | 2023/09/08 | Minor revision|CEP granted|08/09/2023 | |
| 390 | Eucalyptus oil, Rectified | SCHWABE EXTRACTA GMBH & CO. KG Karlsruhe DE | 100021578;100030272 | CEP 2017-033 - Rev 02 | 2023/09/08 | Valid | Herbal | 2023/09/08 | Renewal|CEP granted|08/09/2023; Minor revision|CEP granted|17/02/2021 |
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| 1695 | Granisetron hydrochloride | QILU PHARMACEUTICAL CO., LTD. Jinan CN | 100014051;100061315 | CEP 2011-295 - Rev 03 | 2023/09/07 | Valid | Chemical | 2023/09/07 | Minor revision|CEP granted|07/09/2023; Notification|Accepted - CEP remains valid|28/01/2022; Notification|CEP granted|16/09/2021; Minor revision|CEP granted|21/04/2021 |
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