| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 780 | Oxytocin | ASPEN OSS B.V. Oss NL | R1-CEP 2000-150 - Rev 04 | 2023/08/07 | Valid | Chemical | 2023/08/07 | Monograph revision|CEP granted|07/08/2023 | |||
| 1700 | Mycophenolate mofetil, Process B | LEK PHARMACEUTICALS D.D. Ljubljana SI | R1-CEP 2011-317 - Rev 05 | 2023/08/07 | Valid | Chemical | 2023/08/07 | Notification|CEP granted|07/08/2023; Major revision|CEP granted|17/06/2021; Notification|CEP granted|28/01/2020 |
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| 2762 | Capecitabine | SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan City CN | R1-CEP 2014-343 - Rev 01 | 2023/08/07 | Valid | Chemical | 2023/08/07 | Minor revision|CEP granted|07/08/2023; Renewal|CEP granted|11/12/2020 |
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| 245 | Pyridoxine hydrochloride | DSM Nutritional Products Ltd. Kaiseraugst CH | R1-CEP 2017-027 - Rev 00 | 2023/08/07 | Valid | Chemical | 2023/08/07 | Renewal|CEP granted|07/08/2023 | |||
| 935 | Miconazole | FDC Limited Mumbai IN | R0-CEP 2022-233 - Rev 00 | 2023/08/04 | Valid | 04/08/2028 | Chemical | 2023/08/04 | New application|CEP granted|04/08/2023 | ||
| 2932 | Rivaroxaban | Cambrex Profarmaco Milano S.r.l. Paullo IT | R0-CEP 2022-314 - Rev 00 | 2023/08/04 | Valid | 04/08/2028 | Chemical | 2023/08/04 | New application|CEP granted|04/08/2023 | ||
| 1538 | Lovastatin | KREBS BIOCHEMICALS & INDUSTRIES LIMITED Kothapalli IN | R1-CEP 2004-026 - Rev 03 | 2023/08/04 | Valid | Chemical | 2023/08/04 | Minor revision|CEP granted|04/08/2023; Monograph revision|Accepted - CEP remains valid|15/04/2021 |
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| 1722 | Flunarizine dihydrochloride | OLON S.P.A. Rodano IT | R1-CEP 2004-264 - Rev 05 | 2023/08/04 | Valid | Chemical | 2023/08/04 | Monograph revision|CEP granted|04/08/2023; Minor revision|Accepted - CEP remains valid|01/08/2022; Minor revision|CEP granted|07/01/2021 |
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| 2600 | Olmesartan medoxomil | CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN | R0-CEP 2018-083 - Rev 03 | 2023/08/03 | Valid | 17/03/2025 | Chemical | 2023/08/03 | Minor revision|CEP granted|03/08/2023; Notification|Accepted - CEP remains valid|06/01/2023; Minor revision|Accepted - CEP remains valid|21/12/2022; Minor revision|CEP granted|06/09/2022; Monograph revision|CEP granted|06/05/2022 |
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| 889 | Clomipramine Hydrochloride | R L FINE CHEM PVT. LTD. Bengaluru IN | R0-CEP 2021-157 - Rev 00 | 2023/08/03 | Valid | 03/08/2028 | Chemical | 2023/08/03 | New application|CEP granted|03/08/2023 | ||
| 1490 | Amisulpride | CTX LIFESCIENCES PVT. LIMITED Surat IN | R0-CEP 2022-167 - Rev 00 | 2023/08/03 | Valid | 03/08/2028 | Chemical | 2023/08/03 | New application|CEP granted|03/08/2023 | ||
| 2270 | Sildenafil citrate | SICHUAN KELUN PHARMACEUTICAL CO., LTD. Qionglai CN | R0-CEP 2022-490 - Rev 00 | 2023/08/03 | Valid | 03/08/2028 | Chemical | 2023/08/03 | New application|CEP granted|03/08/2023 | ||
| 2732 | Dienogest | STERLING S.p.A. Solomeo Di Corciano IT | R1-CEP 2016-158 - Rev 00 | 2023/08/02 | Valid | Chemical | 2023/08/02 | Renewal|CEP granted|02/08/2023 | |||
| 2342 | Cefprozil monohydrate | BAIYUNSHAN CHEMICAL PHARMACEUTICAL FACTORY Guangzhou City CN | R0-CEP 2021-488 - Rev 00 | 2023/08/01 | Valid | 01/08/2028 | Chemical | 2023/08/01 | New application|CEP granted|01/08/2023 | ||
| 2857 | Trazodone hydrochloride | PIRAMAL PHARMA LIMITED Digwal Village IN | R0-CEP 2022-166 - Rev 00 | 2023/08/01 | Valid | 01/08/2028 | Chemical | 2023/08/01 | New application|CEP granted|01/08/2023 | ||
| 2219 | Lansoprazole | LEE PHARMA LIMITED Hyderabad IN | R1-CEP 2010-191 - Rev 01 | 2023/08/01 | Valid | Chemical | 2023/08/01 | Major revision|CEP granted|01/08/2023 | |||
| 2404 | Drospirenone, Micronised, non-micronised | NEWCHEM S.p.A. Milano IT | R1-CEP 2015-247 - Rev 01 | 2023/08/01 | Valid | Chemical | 2023/08/01 | Notification|CEP granted|01/08/2023; Notification|Accepted - CEP remains valid|21/07/2022; Renewal|CEP granted|23/06/2022; Major revision|Rejected|30/08/2021; Notification|Accepted - CEP remains valid|14/12/2020 |
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| 2766 | Exemestane | SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. Butterworth MY | R1-CEP 2016-116 - Rev 00 | 2023/08/01 | Valid | Chemical | 2023/08/01 | Renewal|CEP granted|01/08/2023; Monograph revision|Accepted - CEP remains valid|15/04/2020 |
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| 922 | Ketoprofen | MIDAS PHARMA GMBH Ingelheim am Rhein DE | R1-CEP 2017-215 - Rev 01 | 2023/08/01 | Valid | Chemical | 2023/11/28 | Minor revision|Accepted - CEP remains valid|28/11/2023; Administrative procedure|CEP granted|01/08/2023; Renewal|CEP granted|06/07/2023; Minor revision|Accepted - CEP remains valid|11/04/2020 |
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| 1649 | Azithromycin, Dihydrate | HUANGSHI SHIXING PHARMACEUTICAL CO., LTD. Huangshi CN | R0-CEP 2021-114 - Rev 00 | 2023/07/31 | Valid | 31/07/2028 | Chemical | 2023/07/31 | New application|CEP granted|31/07/2023 |
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