| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||
| 2154 | Telmisartan | VERDANT LIFE SCIENCES PRIVATE LIMITED Anakapalli IN | 100048776;100081115 | CEP 2022-366 - Rev 01 | 2026/02/26 | Valid | 08/10/2029 | Chemical | 2026/02/26 | Major revision|CEP granted|26/02/2026; New application|CEP granted|09/10/2024 |
|
| 2191 | Atorvastatin calcium, TBAH Sulphate Route | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2022-271 - Rev 03 | 2026/02/26 | Valid | 23/01/2028 | Chemical | 2026/02/26 | Minor revision|CEP granted|26/02/2026; Minor revision|CEP granted|25/07/2024; Notification|CEP granted|13/12/2023; New application|CEP granted|23/01/2023 |
|
| 2574 | Entacapone | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2011-006 - Rev 02 | 2026/02/26 | Valid | Chemical | 2026/02/26 | Notification|CEP granted|26/02/2026; Notification|CEP granted|19/06/2020 |
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| 2097 | Mebeverine hydrochloride | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2019-061 - Rev 03 | 2026/02/26 | Valid | Chemical | 2026/02/26 | Renewal|CEP granted|26/02/2026; Notification|CEP granted|15/12/2022; Monograph revision|Accepted - CEP remains valid|27/07/2022; Notification|Accepted - CEP remains valid|09/07/2021; Notification|CEP granted|14/12/2020 |
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| 2577 | Oxcarbazepine | ZHEJIANG JIUZHOU PHARMACEUTICAL CO. LTD. Taizhou CN | 100011841;100018560 | CEP 2022-230 - Rev 03 | 2026/02/26 | Valid | 15/12/2028 | Chemical | 2026/02/26 | Minor revision|CEP granted|26/02/2026; Minor revision|CEP granted|12/12/2024; Minor revision|Accepted - CEP remains valid|05/11/2024; Minor revision|CEP granted|01/03/2024; New application|CEP granted|15/12/2023 |
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| 2637 | Pemetrexed disodium heptahydrate | SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan CN | 100037406;100076812 | CEP 2015-217 - Rev 01 | 2026/02/26 | Valid | Chemical | 2026/02/26 | Minor revision|CEP granted|26/02/2026; Monograph revision|Accepted - CEP remains valid|17/07/2023; Renewal|CEP granted|23/02/2022 |
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| 1456 | Olive oil, refined, For parenteral use | SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint Laurent Blangy FR | 100018152;100094230 | CEP 2015-167 - Rev 03 | 2026/02/26 | Valid | Chemical | 2026/02/26 | Minor revision|CEP granted|26/02/2026; Notification|CEP granted|16/01/2025; Minor revision|CEP granted|06/02/2024; Minor revision|Accepted - CEP remains valid|16/03/2022; Renewal|CEP granted|24/08/2020 |
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