| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 603 | Disulfiram | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100099917 | CEP 2019-197 - Rev 03 | 2026/05/13 | Valid | Chemical | 2026/05/13 | Renewal|CEP granted|13/05/2026; Minor revision|CEP granted|23/05/2025; Major revision|CEP granted|15/07/2024; Minor revision|Abandoned|18/03/2024 |
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| 2600 | Olmesartan medoxomil | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2014-196 - Rev 03 | 2026/05/13 | Valid | Chemical | 2026/05/13 | Minor revision|CEP granted|13/05/2026; Major revision|CEP granted|04/02/2025; Minor revision|CEP granted|13/03/2023; Renewal|CEP granted|07/04/2022; Minor revision|CEP granted|09/08/2021; Minor revision|CEP granted|27/01/2021; Minor revision|CEP granted|06/08/2020 |
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| 2606 | Tadalafil, D150 process | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2016-040 - Rev 02 | 2026/05/13 | Valid | Chemical | 2026/05/13 | Notification|CEP granted|13/05/2026; Notification|CEP granted|09/04/2025; Renewal|CEP granted|29/06/2022; Minor revision|CEP granted|29/06/2020 |
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| 2570 | Desloratadine | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2014-047 - Rev 04 | 2026/05/13 | Valid | Chemical | 2026/05/13 | Notification|CEP granted|13/05/2026; Notification|CEP granted|03/04/2025; Minor revision|CEP granted|27/03/2023; Notification|Rejected|23/02/2023; Notification|CEP granted|02/12/2022; Renewal|CEP granted|11/09/2020 |
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| 2779 | Solifenacin succinate | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2017-249 - Rev 04 | 2026/05/13 | Valid | Chemical | 2026/05/13 | Notification|CEP granted|13/05/2026; Notification|CEP granted|09/04/2025; Renewal|Accepted - CEP remains valid|17/09/2024; Minor revision|CEP granted|04/04/2024; Notification|CEP granted|02/12/2022; Minor revision|Accepted - CEP remains valid|23/04/2021 |
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| 2119 | Venlafaxine hydrochloride | ATUL BIOSCIENCE LIMITED Ambernath (East) IN | 100044514;100086818 | CEP 2022-447 - Rev 02 | 2026/05/13 | Valid | 24/04/2029 | Chemical | 2026/05/13 | Minor revision|CEP granted|13/05/2026; Minor revision|CEP granted|23/01/2025; New application|CEP granted|24/04/2024 |
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| 2631 | Rosuvastatin calcium, D518 Process | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2021-265 - Rev 03 | 2026/05/13 | Valid | 05/01/2027 | Chemical | 2026/05/13 | Notification|CEP granted|13/05/2026; Notification|CEP granted|04/04/2025; Notification|CEP granted|05/12/2022; New application|CEP granted|05/01/2022 |
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| 2631 | Rosuvastatin calcium, Process IV | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2024-290 - Rev 02 | 2026/05/13 | Valid | 17/01/2030 | Chemical | 2026/05/13 | Notification|CEP granted|13/05/2026; Notification|CEP granted|10/04/2025; New application|CEP granted|17/01/2025 |
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| 2631 | Rosuvastatin calcium, Process III | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2022-377 - Rev 02 | 2026/05/13 | Valid | 21/02/2028 | Chemical | 2026/05/13 | Notification|CEP granted|13/05/2026; Notification|CEP granted|10/04/2025; New application|CEP granted|21/02/2023 |
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| 3036 | Teriflunomide | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2023-135 - Rev 02 | 2026/05/13 | Valid | 25/07/2029 | Chemical | 2026/05/13 | Notification|CEP granted|13/05/2026; Minor revision|CEP granted|11/03/2025; New application|CEP granted|26/07/2024 |
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| 2223 | Glimepiride, Process-II | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2022-481 - Rev 02 | 2026/05/13 | Valid | 22/09/2028 | Chemical | 2026/05/13 | Notification|CEP granted|13/05/2026; Notification|CEP granted|04/04/2025; New application|CEP granted|22/09/2023 |
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| 2154 | Telmisartan, Process II | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2022-047 - Rev 03 | 2026/05/13 | Valid | 13/05/2027 | Chemical | 2026/05/13 | Notification|CEP granted|13/05/2026; Notification|CEP granted|10/04/2025; Minor revision|CEP granted|16/01/2023; New application|CEP granted|13/05/2022 |
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| 2191 | Atorvastatin calcium, Form-I | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2011-222 - Rev 03 | 2026/05/12 | Valid | Chemical | 2026/05/12 | Minor revision|CEP granted|12/05/2026; Minor revision|CEP granted|11/09/2023; Monograph revision|CEP granted|09/12/2022 |
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| 2598 | Levofloxacin hemihydrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN | 100051463;100098142 | CEP 2019-161 - Rev 04 | 2026/05/12 | Valid | Chemical | 2026/05/12 | Renewal|CEP granted|12/05/2026; Minor revision|Accepted - CEP remains valid|18/11/2024; Notification|CEP granted|17/07/2024; Minor revision|CEP granted|28/09/2023; Minor revision|CEP granted|25/08/2022 |
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| 668 | Flucloxacillin sodium monohydrate, Sterile | FRESENIUS KABI IPSUM S.R.L. Cassina de' Pecchi IT | 100015105;100057989 | CEP 1996-093 - Rev 08 | 2026/05/12 | Valid | Chemical | 2026/05/12 | Administrative procedure|CEP granted|12/05/2026; Minor revision|CEP granted|30/04/2026; Monograph revision|CEP granted|20/05/2022; Major revision|CEP granted|16/06/2021; Notification|CEP granted|02/02/2021 |
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| 929 | Loperamide hydrochloride | FLEMING LABORATORIES LIMITED Nawabpet Village IN | 100015641;100024384 | CEP 2016-168 - Rev 04 | 2026/05/12 | Valid | Chemical | 2026/05/12 | Minor revision|CEP granted|12/05/2026; Renewal|CEP granted|19/04/2024; Administrative procedure|CEP granted|05/05/2022; Major revision|CEP granted|11/02/2022; Minor revision|Rejected|10/06/2021 |
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| 2992 | Lacosamide | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2018-151 - Rev 02 | 2026/05/12 | Valid | Chemical | 2026/05/12 | Minor revision|CEP granted|12/05/2026; Renewal|CEP granted|29/10/2024 |
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| 2422 | Oseltamivir phosphate, Crystalline Form-A, Micronised and Non-micronised | MSN PHARMACHEM PRIVATE LIMITED Sangareddy IN | 100014794;100023345 | CEP 2012-067 - Rev 03 | 2026/05/12 | Valid | Chemical | 2026/05/12 | Minor revision|CEP granted|12/05/2026; Notification|CEP granted|25/10/2023; Minor revision|CEP granted|28/10/2022 |
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| 2033 | Sodium (S)-lactate solution, 60% sodium lactate content | MACCO ORGANIQUES, S.R.O. Bruntal CZ | 100017613;100026377 | CEP 2024-471 - Rev 01 | 2026/05/12 | Valid | 04/05/2031 | Chemical | 2026/05/12 | Administrative procedure|CEP granted|12/05/2026; New application|CEP granted|04/05/2026 |
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| 2857 | Trazodone hydrochloride | AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. Rome IT | 100002269;100000484 | CEP 2021-511 - Rev 02 | 2026/05/12 | Valid | 28/08/2028 | Chemical | 2026/05/12 | Minor revision|CEP granted|12/05/2026; Minor revision|Accepted - CEP remains valid|13/02/2026; Notification|Accepted - CEP remains valid|09/01/2025; Notification|CEP granted|28/03/2024; New application|CEP granted|28/08/2023 |
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