| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1169 | Piperacillin monohydrate, Process III | SHANDONG ANSHUN PHARMACEUTICAL CO., LTD. Dezhou CN | 100039958;100064554 | CEP 2025-549 - Rev 00 | 2026/03/04 | Valid | 04/03/2031 | Chemical | 2026/03/04 | New application|CEP granted|04/03/2026 | |
| 890 | Clonazepam | LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN | 100012055;100053935 | CEP 2009-101 - Rev 02 | 2026/03/04 | Valid | Chemical | 2026/03/04 | Monograph revision|CEP granted|04/03/2026; Minor revision|CEP granted|10/08/2023 |
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| 3039 | Dronedarone hydrochloride, Crystalline, micronised and non-micronised | MSN LABORATORIES PRIVATE LIMITED Sangareddy IN | 100011732;100018657 | CEP 2020-033 - Rev 01 | 2026/03/04 | Valid | 09/08/2027 | Chemical | 2026/03/04 | Minor revision|CEP granted|04/03/2026; New application|CEP granted|09/08/2022 |
|
| 2235 | Methylphenidate hydrochloride | VERANOVA, L.P. West Deptford US | 100012273;100018937 | CEP 2017-119 - Rev 02 | 2026/03/03 | Valid | Chemical | 2026/03/03 | Minor revision|CEP granted|03/03/2026; Minor revision|CEP granted|14/10/2024; Minor revision|Accepted - CEP remains valid|25/04/2023; Renewal|CEP granted|22/02/2023; Minor revision|Accepted - CEP remains valid|08/06/2022 |
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| 2296 | Pantoprazole sodium sesquihydrate | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100089573 | CEP 2012-205 - Rev 02 | 2026/03/03 | Valid | Chemical | 2026/03/03 | Notification|CEP granted|03/03/2026; Minor revision|CEP granted|09/04/2024; Notification|Rejected|22/02/2024 |
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| 2219 | Lansoprazole | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100089573 | CEP 2010-309 - Rev 03 | 2026/03/03 | Valid | Chemical | 2026/03/03 | Notification|CEP granted|03/03/2026; Minor revision|CEP granted|18/12/2024; Notification|CEP granted|06/08/2021 |
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| 2858 | Mometasone furoate monohydrate, Micronised | STERLING S.p.A. Corciano IT | 100024377;100033551 | CEP 2025-557 - Rev 00 | 2026/03/03 | Valid | 03/03/2031 | Chemical | 2026/03/03 | New application|CEP granted|03/03/2026 | |
| 2132 | Torasemide | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2021-167 - Rev 01 | 2026/03/03 | Valid | 10/10/2027 | Chemical | 2026/03/03 | Major revision|CEP granted|03/03/2026; New application|CEP granted|10/10/2022 |
|
| 627 | Nifedipine | MOEHS IBERICA S.L. Rubi ES | 100029092;100068825 | CEP 1996-105 - Rev 06 | 2026/03/03 | Valid | Chemical | 2026/03/03 | Monograph revision|CEP granted|03/03/2026; Minor revision|CEP granted|22/04/2024 |
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| 718 | Glibenclamide, Non-micronised, micronised | USV PRIVATE LIMITED Mumbai IN | 100006251;100010851 | CEP 2000-090 - Rev 06 | 2026/03/02 | Valid | Chemical | 2026/03/02 | Minor revision|CEP granted|02/03/2026; Minor revision|CEP granted|19/04/2024; Notification|Rejected|22/01/2024 |
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| 2331 | Rabeprazole sodium hydrate, Form-Y (RBL process) | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2020-382 - Rev 01 | 2026/03/02 | Valid | Chemical | 2026/03/02 | Renewal|CEP granted|02/03/2026; Minor revision|Accepted - CEP remains valid|19/07/2024; New application|CEP granted|19/03/2021 |
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| 2780 | Temozolomide | BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN | 100028906;100063062 | CEP 2019-053 - Rev 01 | 2026/03/02 | Valid | Chemical | 2026/03/02 | Renewal|CEP granted|02/03/2026 | ||
| 2330 | Leflunomide | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100099996 | CEP 2018-269 - Rev 03 | 2026/03/02 | Valid | Chemical | 2026/03/02 | Renewal|CEP granted|02/03/2026; Minor revision|CEP granted|11/09/2024; Minor revision|CEP granted|08/09/2023 |
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| 1180 | Buprenorphine | NORAMCO, LLC. Wilmington US | 100048651;100080628 | CEP 2007-190 - Rev 06 | 2026/03/02 | Valid | Chemical | 2026/03/02 | Minor revision|CEP granted|02/03/2026; Notification|CEP granted|20/06/2024; Minor revision|CEP granted|07/12/2022; Notification|Accepted - CEP remains valid|17/06/2022; Notification|CEP granted|25/05/2020 |
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| 2258 | Olanzapine | ZHEJIANG SUPOR PHARMACEUTICALS CO., LTD. Shaoxing CN | 100022886;100031604 | CEP 2019-182 - Rev 02 | 2026/03/02 | Valid | Chemical | 2026/03/02 | Renewal|CEP granted|02/03/2026; Minor revision|CEP granted|12/09/2022; Minor revision|Accepted - CEP remains valid|09/03/2022 |
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| 2790 | Clopidogrel besilate, Process II, form-III | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2019-243 - Rev 02 | 2026/03/02 | Valid | Chemical | 2026/03/02 | Renewal|CEP granted|02/03/2026; Minor revision|Accepted - CEP remains valid|21/08/2024; Minor revision|Accepted - CEP remains valid|05/09/2022; Notification|Rejected|05/08/2022; Notification|CEP granted|11/07/2022 |
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| 823 | Etoposide | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1999-144 - Rev 09 | 2026/03/02 | Valid | Chemical | 2026/03/02 | Minor revision|CEP granted|02/03/2026; Minor revision|CEP granted|24/03/2025; Minor revision|Accepted - CEP remains valid|04/03/2024; Notification|CEP granted|04/01/2022; Minor revision|CEP granted|29/06/2020 |
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| 1473 | Soya-bean oil, refined, IV | SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint Laurent Blangy FR | 100018152;100094230 | CEP 2011-115 - Rev 04 | 2026/03/02 | Valid | Chemical | 2026/03/02 | Minor revision|CEP granted|02/03/2026; Notification|CEP granted|16/01/2025; Minor revision|Accepted - CEP remains valid|26/08/2024; Minor revision|CEP granted|27/11/2023; Minor revision|Accepted - CEP remains valid|15/09/2021 |
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| 1270 | Terconazole | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100089573 | CEP 2022-298 - Rev 02 | 2026/03/02 | Valid | 13/11/2029 | Chemical | 2026/03/02 | Notification|CEP granted|02/03/2026; Minor revision|CEP granted|27/05/2025; New application|CEP granted|13/11/2024 |
|
| 1710 | Bisoprolol fumarate | EGIS Pharmaceuticals PLC. Budapest X HU | 100001091;100001662 | CEP 2019-090 - Rev 01 | 2026/02/26 | Valid | Chemical | 2026/02/26 | Renewal|CEP granted|26/02/2026 |
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