| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1449 | Mometasone furoate, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2007-194 - Rev 05 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; Minor revision|CEP granted|02/06/2025; Minor revision|CEP granted|26/08/2022; Notification|Accepted - CEP remains valid|26/02/2021 |
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| 2574 | Entacapone | HEC PHARM GMBH Berlin DE | 100002583;100098718 | CEP 2013-127 - Rev 04 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Minor revision|CEP granted|01/04/2026; Notification|CEP granted|31/01/2025; Notification|Accepted - CEP remains valid|12/03/2024; Minor revision|Accepted - CEP remains valid|02/01/2024; Minor revision|CEP granted|06/07/2022; Monograph revision|CEP granted|28/09/2020 |
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| 1090 | Clobetasone butyrate, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2012-282 - Rev 02 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; Minor revision|CEP granted|30/10/2025; Notification|Accepted - CEP remains valid|01/03/2021; Notification|Accepted - CEP remains valid|14/12/2020 |
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| 1615 | Finasteride | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2011-351 - Rev 04 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Minor revision|CEP granted|01/04/2026; Notification|Rejected|19/02/2026; Minor revision|Rejected|16/07/2025; Minor revision|CEP granted|04/11/2024; Minor revision|CEP granted|10/07/2023; Minor revision|CEP granted|31/03/2020 |
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| 809 | Betamethasone dipropionate, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2012-079 - Rev 01 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026 | ||
| 312 | Betamethasone, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2011-285 - Rev 02 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026 | ||
| 561 | Methylprednisolone, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2014-015 - Rev 03 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; Minor revision|CEP granted|01/12/2025; Minor revision|CEP granted|03/05/2022 |
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| 734 | Prednisolone acetate, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2018-089 - Rev 04 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; Notification|CEP granted|12/01/2026; Minor revision|Accepted - CEP remains valid|10/07/2025; Renewal|CEP granted|29/07/2024; Minor revision|CEP granted|10/08/2020 |
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| 735 | Prednisolone sodium phosphate, Process 2 | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2016-205 - Rev 02 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; Notification|CEP granted|12/06/2023; Renewal|CEP granted|14/01/2022 |
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| 334 | Hydrocortisone acetate, Micronised, Grades I and II | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2016-228 - Rev 04 | 2026/04/01 | Valid | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; Minor revision|CEP granted|18/09/2025; Renewal|CEP granted|27/10/2023; Minor revision|CEP granted|16/09/2022 |
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| 821 | Estradiol hemihydrate, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2020-067 - Rev 01 | 2026/04/01 | Valid | 05/05/2027 | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; Notification|Accepted - CEP remains valid|27/04/2023; New application|CEP granted|05/05/2022 |
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| 353 | Prednisolone, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2020-194 - Rev 03 | 2026/04/01 | Valid | 23/06/2027 | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; Notification|CEP granted|12/01/2026; Minor revision|CEP granted|03/03/2025; New application|CEP granted|23/06/2022 |
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| 2154 | Telmisartan, Process IV, micronised and non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2023-181 - Rev 02 | 2026/04/01 | Valid | 03/04/2029 | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; Minor revision|CEP granted|01/09/2025; Notification|Accepted - CEP remains valid|11/07/2024; New application|CEP granted|03/04/2024 |
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| 2904 | Carbon monoxide intermix (5 per cent) in nitrogen | SOL S.P.A. Monza IT | 100002061;100001723 | CEP 2025-390 - Rev 00 | 2026/04/01 | Valid | 01/04/2031 | Chemical | 2026/04/01 | New application|CEP granted|01/04/2026 | |
| 388 | Dexamethasone, Micronised | SYMBIOTEC PHARMALAB LIMITED Indore IN | 100018972;100095999 | CEP 2023-083 - Rev 01 | 2026/04/01 | Valid | 26/05/2030 | Chemical | 2026/04/01 | Notification|CEP granted|01/04/2026; New application|CEP granted|26/05/2025 |
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| 2932 | Rivaroxaban | KOPRAN RESEARCH LABORATORIES LIMITED Mumbai IN | 100033667;100081898 | CEP 2025-028 - Rev 00 | 2026/04/01 | Valid | 01/04/2031 | Chemical | 2026/04/01 | New application|CEP granted|01/04/2026 | |
| 1031 | Sodium picosulfate | CAMBREX PROFARMACO MILANO S.R.L. Paullo IT | 100011608;100018301 | CEP 2024-482 - Rev 01 | 2026/04/01 | Valid | 06/03/2031 | Chemical | 2026/04/01 | Minor revision|CEP granted|01/04/2026; New application|CEP granted|06/03/2026 |
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| 2296 | Pantoprazole sodium sesquihydrate | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2009-272 - Rev 04 | 2026/03/31 | Valid | Chemical | 2026/03/31 | Notification|CEP granted|31/03/2026; Notification|CEP granted|23/08/2022 |
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| 2219 | Lansoprazole | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2011-263 - Rev 02 | 2026/03/31 | Valid | Chemical | 2026/03/31 | Notification|CEP granted|31/03/2026; Notification|CEP granted|24/08/2022 |
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| 2531 | Clopidogrel hydrogen sulfate | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2011-267 - Rev 02 | 2026/03/31 | Valid | Chemical | 2026/03/31 | Notification|CEP granted|31/03/2026; Notification|CEP granted|24/08/2022 |
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