| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2600 | Olmesartan medoxomil | TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN | 100004452;100001862 | CEP 2023-126 - Rev 00 | 2026/02/19 | Valid | 19/02/2031 | Chemical | 2026/02/19 | New application|CEP granted|19/02/2026 | |
| 1425 | Fosfomycin trometamol | GUILIN HWASUN PHARMACEUTICAL CO., LTD. Guilin CN | 100034192;100054092 | CEP 2025-152 - Rev 00 | 2026/02/19 | Valid | 19/02/2031 | Chemical | 2026/02/19 | New application|CEP granted|19/02/2026 | |
| 2857 | Trazodone hydrochloride, Process-II, Milled/Unmilled | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2025-141 - Rev 02 | 2026/02/19 | Valid | 13/11/2030 | Chemical | 2026/02/19 | Administrative procedure|CEP granted|19/02/2026; Minor revision|CEP granted|03/02/2026; New application|CEP granted|13/11/2025 |
|
| 50 | Procaine Hydrochloride | FLARER S.A. Balerna CH | 100047920;100079248 | CEP 2021-223 - Rev 03 | 2026/02/19 | Valid | 14/11/2027 | Chemical | 2026/02/19 | Monograph revision|CEP granted|19/02/2026; Minor revision|Accepted - CEP remains valid|03/12/2025; Minor revision|CEP granted|24/02/2025; Minor revision|CEP granted|02/02/2024; New application|CEP granted|14/11/2022 |
|
| 52 | Rifampicin | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2009-275 - Rev 06 | 2026/02/18 | Valid | Chemical | 2026/02/18 | Minor revision|CEP granted|18/02/2026; Minor revision|CEP granted|27/05/2024; Minor revision|CEP granted|27/07/2022; Major revision|CEP granted|24/11/2021 |
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| 1756 | Lamotrigine | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2011-010 - Rev 06 | 2026/02/18 | Valid | Chemical | 2026/02/18 | Minor revision|CEP granted|18/02/2026; Minor revision|CEP granted|03/02/2025; Minor revision|CEP granted|12/07/2024; Notification|CEP granted|19/06/2023; Minor revision|CEP granted|18/02/2022; Minor revision|CEP granted|06/04/2020 |
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| 179 | Erythromycin, Micronised, powder | ERCROS S.A. Aranjuez ES | 100016091;100024873 | CEP 2003-129 - Rev 03 | 2026/02/18 | Valid | Chemical | 2026/02/18 | Minor revision|CEP granted|18/02/2026; Major revision|Rejected|04/11/2025; Monograph revision|CEP granted|26/03/2021 |
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| 1615 | Finasteride | SHAKTI LIFESCIENCE PRIVATE LIMITED Mumbai IN | 100048889;100089578 | CEP 2023-335 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 1275 | Ursodeoxycholic acid | ZHONGSHAN BELLING BIOTECHNOLOGY CO., LTD. Zhongshan City CN | 100039390;100062018 | CEP 2018-237 - Rev 02 | 2026/02/18 | Valid | Chemical | 2026/02/18 | Monograph revision|CEP granted|18/02/2026; Renewal|CEP granted|10/07/2024; Notification|Accepted - CEP remains valid|26/09/2023 |
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| 579 | Aprotinin concentrated solution, Activity: 100 - 136 Ph. Eur. Units of aprotinin activity per mL Bacterial endotoxin free | PENTAPHARM AG Aesch CH | 100025404;100052203 | CEP 2002-095 - Rev 08 | 2026/02/18 | Valid | Chemical and TSE | 2026/02/18 | Monograph revision|CEP granted|18/02/2026; Monograph revision|CEP granted|20/03/2025; Notification|Accepted - CEP remains valid|17/07/2023; Transfer of holdership|CEP granted|30/06/2023; Notification|Accepted - CEP remains valid|04/04/2022; Monograph revision|CEP granted|23/02/2022; Minor revision|Accepted - CEP remains valid|27/11/2020 |
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| 3139 | Brivaracetam, Non-micronised and micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2024-064 - Rev 02 | 2026/02/18 | Valid | 25/02/2030 | Chemical | 2026/02/18 | Minor revision|CEP granted|18/02/2026; Minor revision|CEP granted|04/12/2025; New application|CEP granted|25/02/2025 |
|
| 2778 | Sitagliptin phosphate monohydrate | QUIMICA SINTETICA S.A. Alcala De Henares ES | 100012121;100019020 | CEP 2024-564 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 1449 | Mometasone furoate, Micronised and non-micronised | BREATHGREEN PHARMACEUTICAL CO. LTD. Zaozhuang CN | 100048781;100081153 | CEP 2025-361 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 2932 | Rivaroxaban | DIJIA PHARMACEUTICAL GROUP CO., LTD. Weihai CN | 100048717;100100668 | CEP 2024-174 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 1909 | Sodium polystyrene sulfonate | VALENS PHARMACHEM PRIVATE LIMITED Nadiad IN | 100052857;100093188 | CEP 2025-058 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 572 | Timolol maleate | TIANJIN MINXIANG PHARMACEUTICAL CO., LTD. Jinghai CN | 100034356;100054454 | CEP 2024-458 - Rev 00 | 2026/02/18 | Valid | 18/02/2031 | Chemical | 2026/02/18 | New application|CEP granted|18/02/2026 | |
| 2631 | Rosuvastatin calcium, Process I | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2015-114 - Rev 04 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; Minor revision|CEP granted|21/10/2024; Notification|Accepted - CEP remains valid|20/03/2023; Major revision|CEP granted|27/01/2023; Major revision|CEP granted|22/02/2022; Renewal|CEP granted|16/08/2021; Monograph revision|CEP granted|13/08/2020 |
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| 2154 | Telmisartan, Non-micronised, micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2009-077 - Rev 03 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; Notification|Accepted - CEP remains valid|04/03/2025; Notification|Accepted - CEP remains valid|12/06/2024; Minor revision|Accepted - CEP remains valid|05/04/2023; Notification|Accepted - CEP remains valid|09/06/2022; Notification|Accepted - CEP remains valid|20/10/2021; Notification|CEP granted|14/04/2021; Major revision|Abandoned|23/02/2021; Minor revision|Accepted - CEP remains valid|23/10/2020 |
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| 53 | Streptomycin sulfate | North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN | 100021261;100029965 | CEP 2001-394 - Rev 04 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Monograph revision|CEP granted|16/02/2026; Minor revision|Accepted - CEP remains valid|22/07/2024; Minor revision|CEP granted|29/06/2023; Minor revision|CEP granted|27/08/2021; Monograph revision|Accepted - CEP remains valid|12/01/2021 |
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| 2531 | Clopidogrel hydrogen sulfate, Form II, micronised and non-micronised | MSN ORGANICS PRIVATE LIMITED Bibinagar Village IN | 100012074;100018617 | CEP 2015-331 - Rev 01 | 2026/02/16 | Valid | Chemical | 2026/02/16 | Minor revision|CEP granted|16/02/2026; Minor revision|Accepted - CEP remains valid|11/08/2022; Renewal|CEP granted|26/01/2022; Minor revision|CEP granted|01/12/2020 |
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