| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1244 | Morphine hemisulfate 2.5-hydrate | FRANCOPIA Paris FR | 100041331;100098338 | CEP 2000-126 - Rev 08 | 2025/10/21 | Valid | Chemical | 2025/10/21 | Notification|CEP granted|21/10/2025; Monograph revision|CEP granted|26/04/2024; Notification|CEP granted|01/03/2024; Notification|CEP granted|02/05/2022; Notification|Accepted - CEP remains valid|20/02/2020 |
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| 3078 | Riociguat, Micronised and non-micronised | MSN LIFE SCIENCES PRIVATE LIMITED Medak IN | 100018316;100027671 | CEP 2023-245 - Rev 00 | 2025/10/21 | Valid | 21/10/2030 | Chemical | 2025/10/21 | New application|CEP granted|21/10/2025 | |
| 1793 | Oxycodone hydrochloride | FRANCOPIA Paris FR | 100041331;100098338 | CEP 2008-249 - Rev 04 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Notification|CEP granted|20/10/2025; Minor revision|Accepted - CEP remains valid|19/04/2024; Notification|CEP granted|01/03/2024; Notification|CEP granted|02/05/2022; Minor revision|Accepted - CEP remains valid|01/04/2020 |
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| 97 | Morphine hydrochloride trihydrate | FRANCOPIA Paris FR | 100041331;100098338 | CEP 2008-208 - Rev 05 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Notification|CEP granted|20/10/2025; Monograph revision|CEP granted|25/04/2024; Notification|CEP granted|01/03/2024; Notification|Accepted - CEP remains valid|22/11/2023; Transfer of holdership|CEP granted|25/05/2022 |
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| 729 | Naloxone hydrochloride dihydrate | FRANCOPIA Paris FR | 100041331;100098338 | CEP 1996-050 - Rev 08 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Notification|CEP granted|20/10/2025; Notification|CEP granted|22/02/2024; Major revision|Accepted - CEP remains valid|24/10/2023; Notification|Accepted - CEP remains valid|06/02/2023; Notification|CEP granted|02/05/2022; Minor revision|Accepted - CEP remains valid|10/08/2020 |
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| 1790 | Naltrexone hydrochloride | FRANCOPIA Paris FR | 100041331;100098338 | CEP 2009-287 - Rev 04 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Notification|CEP granted|20/10/2025; Notification|Accepted - CEP remains valid|24/02/2025; Notification|CEP granted|01/03/2024; Notification|CEP granted|02/05/2022; Minor revision|Accepted - CEP remains valid|29/01/2021; Minor revision|CEP granted|16/07/2020 |
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| 622 | Meclozine dihydrochloride | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2011-078 - Rev 03 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Notification|CEP granted|20/10/2025; Minor revision|Accepted - CEP remains valid|21/09/2022; Notification|CEP granted|12/08/2022; Major revision|CEP granted|13/07/2022 |
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| 74 | Codeine phosphate hemihydrate | FRANCOPIA Paris FR | 100041331;100098338 | CEP 1997-118 - Rev 13 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Notification|CEP granted|20/10/2025; Minor revision|Accepted - CEP remains valid|11/09/2025; Notification|CEP granted|01/03/2024; Minor revision|CEP granted|27/02/2023; Notification|CEP granted|02/05/2022; Minor revision|Accepted - CEP remains valid|01/04/2022; Minor revision|Accepted - CEP remains valid|24/09/2020 |
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| 2372 | Esomeprazole magnesium trihydrate | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2014-111 - Rev 03 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Notification|CEP granted|20/10/2025; Minor revision|CEP granted|26/04/2023; Minor revision|Rejected|23/03/2023; Notification|CEP granted|12/08/2022; Renewal|CEP granted|14/12/2021 |
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| 2258 | Olanzapine, Form-II | QILU PHARMACEUTICAL CO., LTD. Jinan CN | 100014051;100061315 | CEP 2012-191 - Rev 03 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Minor revision|CEP granted|20/10/2025; Minor revision|CEP granted|27/01/2025; Notification|CEP granted|16/09/2021 |
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| 1226 | Imipenem monohydrate, Sterile, Synthetic origin | SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN | 100014777;100050265 | CEP 2024-396 - Rev 00 | 2025/10/20 | Valid | 20/10/2030 | Chemical | 2025/10/20 | New application|CEP granted|20/10/2025 | |
| 2779 | Solifenacin succinate | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2016-080 - Rev 02 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Notification|CEP granted|20/10/2025; Notification|CEP granted|11/08/2022; Renewal|CEP granted|20/12/2021 |
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| 76 | Codeine monohydrate | FRANCOPIA Paris FR | 100041331;100098338 | CEP 2014-143 - Rev 03 | 2025/10/20 | Valid | Chemical | 2025/11/19 | Minor revision|Accepted - CEP remains valid|19/11/2025; Notification|CEP granted|20/10/2025; Notification|CEP granted|01/03/2024; Notification|CEP granted|02/05/2022; Notification|Accepted - CEP remains valid|01/09/2021; Notification|Rejected|05/08/2021; Renewal|CEP granted|26/06/2020 |
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| 491 | Ethylmorphine Hydrochloride | FRANCOPIA Paris FR | 100041331;100098338 | CEP 2012-128 - Rev 03 | 2025/10/20 | Valid | Chemical | 2025/10/20 | Notification|CEP granted|20/10/2025; Notification|CEP granted|01/03/2024; Notification|Accepted - CEP remains valid|17/07/2023; Notification|CEP granted|02/05/2022 |
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| 821 | Estradiol hemihydrate, Dorog site | GEDEON RICHTER PLC. Budapest HU | 100000640;100001653 | CEP 2025-255 - Rev 00 | 2025/10/20 | Valid | 20/10/2030 | Chemical | 2025/10/20 | New application|CEP granted|20/10/2025 | |
| 2406 | Anastrozole, Form-II | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2013-172 - Rev 02 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Minor revision|CEP granted|17/10/2025; Minor revision|Accepted - CEP remains valid|13/07/2023; Notification|Rejected|23/01/2023; Minor revision|CEP granted|15/12/2020 |
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| 1649 | Azithromycin, Monohydrate | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2007-118 - Rev 06 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Notification|CEP granted|12/08/2022; Monograph revision|CEP granted|14/01/2022 |
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| 543 | Carbamazepine, CMZ | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2011-206 - Rev 02 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Notification|CEP granted|24/08/2022 |
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| 2572 | Risedronate sodium 2.5-hydrate | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 2014-010 - Rev 02 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Monograph revision|Accepted - CEP remains valid|05/10/2023; Notification|CEP granted|23/08/2022 |
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| 543 | Carbamazepine | JUBILANT BIOSYS LIMITED Nanjangud IN | 100055198;100098088 | CEP 1999-109 - Rev 07 | 2025/10/17 | Valid | Chemical | 2025/10/17 | Notification|CEP granted|17/10/2025; Notification|CEP granted|23/08/2022 |
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