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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2296 | Pantoprazole sodium sesquihydrate, DC grade | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2023-445 - Rev 00 | 2024/04/17 | Valid | 17/04/2029 | Chemical | 2024/04/17 | New application|CEP granted|17/04/2024 | |
1096 | Doxepin hydrochloride | R L FINE CHEM PVT. LTD. Bengaluru IN | 100016723;100067511 | CEP 2022-355 - Rev 00 | 2024/04/17 | Valid | 17/04/2029 | Chemical | 2024/04/17 | New application|CEP granted|17/04/2024 | |
1146 | Roxithromycin | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shangyu CN | 100022562;100031241 | CEP 2017-064 - Rev 01 | 2024/04/17 | Valid | Chemical | 2024/04/17 | Renewal|CEP granted|17/04/2024 | ||
1211 | Fenticonazole nitrate | RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. Milano IT | 100000942;100001718 | CEP 2014-374 - Rev 01 | 2024/04/17 | Valid | Chemical | 2024/04/17 | Monograph revision|CEP granted|17/04/2024; Minor revision|Accepted - CEP remains valid|22/06/2021; Renewal|CEP granted|10/02/2021 |
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922 | Ketoprofen, Process N | DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR | 100024414;100042624 | CEP 2017-194 - Rev 03 | 2024/04/17 | Valid | Chemical | 2024/04/17 | Minor revision|CEP granted|17/04/2024; Renewal|CEP granted|01/02/2024; Minor revision|CEP granted|25/04/2023 |
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1452 | Nicotine | NICOBRAND LIMITED Coleraine GB | 100002321;100006571 | CEP 2017-101 - Rev 04 | 2024/04/17 | Valid | Chemical | 2024/04/17 | Minor revision|CEP granted|17/04/2024; Renewal|CEP granted|11/12/2023 |
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2013 | Ciprofibrate | SANOFI WINTHROP INDUSTRIE Gentilly FR | 100011564;100021551 | CEP 2011-120 - Rev 05 | 2024/04/17 | Valid | Chemical | 2024/04/17 | Notification|CEP granted|17/04/2024; Monograph revision|CEP granted|30/01/2023; Notification|CEP granted|12/07/2022; Minor revision|CEP granted|20/08/2020 |
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803 | Amiodarone hydrochloride | PMC ISOCHEM Vert Le Petit FR | 100011861;100020972 | CEP 1997-090 - Rev 11 | 2024/04/17 | Valid | Chemical | 2024/04/17 | Minor revision|CEP granted|17/04/2024; Notification|CEP granted|23/11/2022 |
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2131 | Tamsulosin hydrochloride | DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR | 100024414;100042624 | CEP 2022-178 - Rev 00 | 2024/04/16 | Valid | 16/04/2029 | Chemical | 2024/04/16 | New application|CEP granted|16/04/2024 | |
2420 | Tiotropium bromide monohydrate | JEWIM PHARMACEUTICAL (SHANDONG) CO., LTD. Taian CN | 100048112;100079597 | CEP 2023-214 - Rev 00 | 2024/04/16 | Valid | 16/04/2029 | Chemical | 2024/04/16 | New application|CEP granted|16/04/2024 | |
2191 | Atorvastatin calcium, Process-VIII | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2013-094 - Rev 04 | 2024/04/16 | Valid | Chemical | 2024/04/16 | Major revision|CEP granted|16/04/2024; Minor revision|CEP granted|21/02/2023; Monograph revision|CEP granted|02/08/2022; Notification|Accepted - CEP remains valid|17/01/2022; Notification|CEP granted|25/02/2021 |
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2766 | Exemestane | CURIA SPAIN S.A.U. Boecillo ES | 100011649;100019586 | CEP 2017-159 - Rev 06 | 2024/04/16 | Valid | Chemical | 2024/04/16 | Transfer of holdership|CEP granted|16/04/2024; Renewal|CEP granted|20/03/2024; Notification|Accepted - CEP remains valid|17/11/2021; Notification|CEP granted|27/08/2021; Administrative procedure|CEP granted|01/06/2021; Minor revision|CEP granted|07/05/2021; Monograph revision|Accepted - CEP remains valid|24/07/2020 |
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726 | Levamisole Hydrochloride | CHANGZHOU YABANG-QH PHARMACHEM CO., LTD. Chunjiang Town CN | 100019146;100027908 | CEP 2022-376 - Rev 00 | 2024/04/16 | Valid | 16/04/2029 | Chemical | 2024/04/16 | New application|CEP granted|16/04/2024 | |
2182 | Trimebutine maleate | PMC ISOCHEM Vert Le Petit FR | 100011861;100020972 | CEP 2018-026 - Rev 01 | 2024/04/15 | Valid | Chemical | 2024/04/15 | Renewal|CEP granted|15/04/2024; Minor revision|Accepted - CEP remains valid|21/11/2023 |
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2570 | Desloratadine | HAINAN POLY PHARMACEUTICAL COMPANY LIMITED Haikou CN | 100024397;100033569 | CEP 2018-174 - Rev 02 | 2024/04/15 | Valid | Chemical | 2024/04/15 | Renewal|CEP granted|15/04/2024; Minor revision|CEP granted|16/03/2022 |
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1448 | Metoprolol succinate | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2004-028 - Rev 05 | 2024/04/15 | Valid | Chemical | 2024/04/15 | Minor revision|CEP granted|15/04/2024; Minor revision|Accepted - CEP remains valid|04/12/2023; Minor revision|CEP granted|11/04/2023 |
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978 | Calcium folinate hydrate | GMT Fine Chemicals SA Couvet CH | 100019396;100028159 | CEP 2004-009 - Rev 04 | 2024/04/15 | Valid | Chemical | 2024/04/15 | Minor revision|CEP granted|15/04/2024; Minor revision|Accepted - CEP remains valid|29/01/2024; Minor revision|Accepted - CEP remains valid|12/08/2022; Minor revision|Accepted - CEP remains valid|01/12/2021; Minor revision|Accepted - CEP remains valid|15/03/2021 |
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2125 | Doxazosin mesilate | NIFTY LABS PVT. LTD. Hyderabad IN | 100014767;100042749 | CEP 2022-257 - Rev 00 | 2024/04/15 | Valid | 15/04/2029 | Chemical | 2024/04/15 | New application|CEP granted|15/04/2024 | |
2258 | Olanzapine | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | CEP 2012-161 - Rev 03 | 2024/04/15 | Valid | Chemical | 2024/04/15 | Notification|CEP granted|15/04/2024; Minor revision|CEP granted|04/01/2022; Administrative procedure|CEP granted|12/08/2020; Notification|Abandoned|05/08/2020 |
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919 | Ipratropium bromide | MELODY HEALTHCARE PVT. LTD. Mumbai IN | 100014822;100073679 | CEP 2017-302 - Rev 03 | 2024/04/15 | Valid | Chemical | 2024/04/15 | Renewal|CEP granted|15/04/2024; Major revision|CEP granted|10/01/2023; Minor revision|Accepted - CEP remains valid|16/12/2020; Minor revision|CEP granted|19/06/2020 |