| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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| 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 |
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| 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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| 1491 | Amlodipine besilate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN | 100051463;100098142 | CEP 2006-119 - Rev 05 | 2026/02/26 | Valid | Chemical | 2026/02/26 | Monograph revision|CEP granted|26/02/2026; Notification|CEP granted|12/07/2024 |
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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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| 2629 | Rivastigmine | Erregierre S.p.A. San Paolo D'Argon IT | 100012035;100021179 | CEP 2025-073 - Rev 00 | 2026/02/25 | Valid | 25/02/2031 | Chemical | 2026/02/25 | New application|CEP granted|25/02/2026 | |
| 1012 | Famotidine | HALEOS LABS LIMITED Hyderabad IN | 100039495;100077080 | CEP 2023-455 - Rev 01 | 2026/02/25 | Valid | 03/09/2030 | Chemical | 2026/02/25 | Notification|CEP granted|25/02/2026; New application|CEP granted|03/09/2025 |
|
| 803 | Amiodarone hydrochloride | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100099996 | CEP 2024-451 - Rev 00 | 2026/02/25 | Valid | 25/02/2031 | Chemical | 2026/02/25 | New application|CEP granted|25/02/2026 | |
| 3078 | Riociguat, Micronised | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2025-423 - Rev 00 | 2026/02/25 | Valid | 25/02/2031 | Chemical | 2026/02/25 | New application|CEP granted|25/02/2026 | |
| 1611 | Diosmin, Chenxiang site, micronised and non-micronised | CHENGDU YAZHONG BIO-PHARMACEUTICAL CO., LTD. Pengzhou CN | 100048965;100095919 | CEP 2025-251 - Rev 01 | 2026/02/25 | Valid | 15/07/2030 | Chemical | 2026/02/25 | Minor revision|CEP granted|25/02/2026; New application|CEP granted|15/07/2025 |
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| 823 | Etoposide | SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN | 100014777;100050265 | CEP 2025-052 - Rev 00 | 2026/02/25 | Valid | 25/02/2031 | Chemical | 2026/02/25 | New application|CEP granted|25/02/2026 | |
| 3049 | Etonogestrel, Micronised and non-micronised | ASPEN OSS B.V. Oss NL | 100011619;100050602 | CEP 2024-341 - Rev 00 | 2026/02/25 | Valid | 25/02/2031 | Chemical | 2026/02/25 | New application|CEP granted|25/02/2026 | |
| 2777 | Pregabalin | HIKAL LIMITED Bengaluru IN | 100014769;100023445 | CEP 2016-181 - Rev 03 | 2026/02/25 | Valid | Chemical | 2026/02/25 | Minor revision|CEP granted|25/02/2026; Minor revision|CEP granted|28/06/2023; Notification|CEP granted|07/09/2022; Renewal|CEP granted|15/06/2022; Minor revision|Accepted - CEP remains valid|20/12/2021; Minor revision|CEP granted|18/03/2021; Major revision|CEP granted|24/11/2020; Notification|Accepted - CEP remains valid|15/07/2020 |
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| 2306 | Gemcitabine hydrochloride, GA process | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2022-499 - Rev 01 | 2026/02/25 | Valid | 28/02/2028 | Chemical | 2026/02/25 | Major revision|CEP granted|25/02/2026; New application|CEP granted|28/02/2023 |
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| 2191 | Atorvastatin calcium, Crystalline | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2011-009 - Rev 05 | 2026/02/25 | Valid | Chemical | 2026/02/25 | Minor revision|CEP granted|25/02/2026; Notification|Accepted - CEP remains valid|11/09/2025; Major revision|CEP granted|03/12/2024; Monograph revision|CEP granted|08/12/2022; Major revision|CEP granted|22/04/2021; Minor revision|Rejected|26/10/2020; Minor revision|CEP granted|18/06/2020 |
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| 168 | Ampicillin trihydrate, Enzymatic route | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2022-482 - Rev 03 | 2026/02/25 | Valid | 06/06/2028 | Chemical | 2026/02/25 | Minor revision|CEP granted|25/02/2026; Administrative procedure|CEP granted|28/11/2023; Notification|CEP granted|21/11/2023; New application|CEP granted|06/06/2023 |
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