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 |
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332 | Heparin calcium, for parenteral preparations | OPOCRIN SpA Corlo Di Formigine IT | 100008856;100018068 | CEP 2007-211 - Rev 04 | 2024/07/15 | Valid | Chemical and TSE | 2024/07/15 | Notification|CEP granted|15/07/2024 | ||
2585 | Rizatriptan benzoate | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2011-299 - Rev 03 | 2024/07/15 | Valid | Chemical | 2024/07/15 | Notification|CEP granted|15/07/2024 | ||
2737 | Zolmitriptan | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2020-422 - Rev 02 | 2024/07/15 | Valid | 18/05/2027 | Chemical | 2024/07/15 | Notification|CEP granted|15/07/2024; Minor revision|CEP granted|13/10/2023; Minor revision|Accepted - CEP remains valid|03/08/2023; New application|CEP granted|18/05/2022 |
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595 | Bisacodyl | DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN | 100012005;100062133 | CEP 2007-163 - Rev 04 | 2024/07/15 | Valid | Chemical | 2024/07/15 | Notification|CEP granted|15/07/2024; Minor revision|CEP granted|16/03/2023 |
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185 | Potassium chloride | K+S MINERALS AND AGRICULTURE GMBH Kassel DE | 100020039;100051870 | CEP 2010-380 - Rev 05 | 2024/07/15 | Valid | Chemical | 2024/07/15 | Minor revision|CEP granted|15/07/2024; Minor revision|CEP granted|09/06/2023; Minor revision|Accepted - CEP remains valid|13/06/2022; Administrative procedure|CEP granted|10/03/2021; Minor revision|CEP granted|25/02/2021 |
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193 | Sodium chloride | K+S MINERALS AND AGRICULTURE GMBH Kassel DE | 100020039;100051870 | CEP 2007-367 - Rev 03 | 2024/07/15 | Valid | Chemical | 2024/07/15 | Minor revision|CEP granted|15/07/2024; Minor revision|Accepted - CEP remains valid|24/04/2023; Minor revision|Accepted - CEP remains valid|13/06/2022; Minor revision|Accepted - CEP remains valid|24/02/2021 |
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1710 | Bisoprolol fumarate | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2014-264 - Rev 02 | 2024/07/15 | Valid | Chemical | 2024/07/15 | Minor revision|CEP granted|15/07/2024; Major revision|CEP granted|12/10/2022; Renewal|CEP granted|28/06/2021 |
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379 | Cetylpyridinium Chloride | DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN | 100012005;100062133 | CEP 2007-029 - Rev 07 | 2024/07/15 | Valid | Chemical | 2024/07/15 | Notification|CEP granted|15/07/2024; Minor revision|CEP granted|08/11/2023; Minor revision|CEP granted|03/05/2023 |
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378 | Cetrimide | DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN | 100012005;100062133 | CEP 2007-199 - Rev 03 | 2024/07/15 | Valid | Chemical | 2024/07/15 | Notification|CEP granted|15/07/2024; Minor revision|Accepted - CEP remains valid|22/05/2023; Minor revision|CEP granted|22/06/2022 |
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2573 | Candesartan cilexetil, Process II | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2019-303 - Rev 02 | 2024/07/15 | Valid | 02/04/2025 | Chemical | 2024/07/15 | Notification|CEP granted|15/07/2024; Major revision|CEP granted|12/10/2022 |
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1031 | Sodium picosulfate | DISHMAN CARBOGEN AMCIS LIMITED Ahmedabad IN | 100012005;100062133 | CEP 2020-021 - Rev 02 | 2024/07/15 | Valid | 14/12/2025 | Chemical | 2024/07/15 | Notification|CEP granted|15/07/2024; Minor revision|CEP granted|02/05/2024; New application|CEP granted|14/12/2020 |
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603 | Disulfiram | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100078783 | CEP 2019-197 - Rev 01 | 2024/07/15 | Valid | 05/07/2026 | Chemical | 2024/07/15 | Major revision|CEP granted|15/07/2024; Minor revision|Abandoned|18/03/2024 |
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1559 | Risperidone | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2006-060 - Rev 06 | 2024/07/12 | Valid | Chemical | 2024/07/12 | Notification|CEP granted|12/07/2024; Minor revision|Accepted - CEP remains valid|23/10/2020 |
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1651 | Clarithromycin | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2005-266 - Rev 06 | 2024/07/12 | Valid | Chemical | 2024/07/12 | Notification|CEP granted|12/07/2024; Major revision|CEP granted|23/11/2023; Minor revision|Accepted - CEP remains valid|14/01/2021 |
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2219 | Lansoprazole | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2008-240 - Rev 03 | 2024/07/12 | Valid | Chemical | 2024/07/12 | Notification|CEP granted|12/07/2024 | ||
942 | Omeprazole, Micronised and sieved grade | ESTEVE QUIMICA S.A. Barcelona ES | 100002266;100056508 | CEP 1998-145 - Rev 11 | 2024/07/12 | Valid | Chemical | 2024/07/12 | Minor revision|CEP granted|12/07/2024; Notification|Accepted - CEP remains valid|20/04/2023; Transfer of holdership|CEP granted|16/03/2022; Notification|Accepted - CEP remains valid|04/11/2021; Notification|CEP granted|24/03/2020 |
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1558 | Propofol, PFL | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100022690 | CEP 2024-066 - Rev 00 | 2024/07/12 | Valid | 12/07/2029 | Chemical | 2024/07/12 | New application|CEP granted|12/07/2024 | |
1335 | Itraconazole | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2005-269 - Rev 06 | 2024/07/12 | Valid | Chemical | 2024/07/12 | Notification|CEP granted|12/07/2024; Minor revision|CEP granted|16/09/2022 |
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1065 | Alprazolam | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2008-060 - Rev 02 | 2024/07/12 | Valid | Chemical | 2024/07/12 | Notification|CEP granted|12/07/2024 | ||
1756 | Lamotrigine | TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN | 100051463;100090213 | CEP 2009-157 - Rev 02 | 2024/07/12 | Valid | Chemical | 2024/07/12 | Notification|CEP granted|12/07/2024 |