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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2777 | Pregabalin | AALIDHRA PHARMACHEM PRIVATE LIMITED Nandesari IN | 100042480;100070177 | R0-CEP 2019-085 - Rev 02 | 2023/03/07 | Valid | 15/09/2025 | Chemical | 2023/03/07 | Minor revision|CEP granted|07/03/2023; Minor revision|CEP granted|08/03/2022 |
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2768 | Fluticasone furoate, Process 1 | CORAL DRUGS PRIVATE LIMITED New Delhi IN | 100019182;100042823 | R0-CEP 2021-372 - Rev 00 | 2023/03/07 | Valid | 07/03/2028 | Chemical | 2023/03/07 | New application|CEP granted|07/03/2023 | |
2858 | Mometasone furoate monohydrate | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | R0-CEP 2022-287 - Rev 01 | 2023/03/07 | Valid | 20/02/2028 | Chemical | 2023/03/07 | Administrative procedure|CEP granted|07/03/2023; New application|CEP granted|20/02/2023 |
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2787 | Esomeprazole magnesium dihydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | R1-CEP 2014-333 - Rev 01 | 2023/03/07 | Valid | Chemical | 2023/03/07 | Notification|CEP granted|07/03/2023; Renewal|CEP granted|26/04/2022; Minor revision|CEP granted|11/03/2020 |
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2616 | Topiramate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | R0-CEP 2020-130 - Rev 01 | 2023/03/06 | Valid | 13/07/2027 | Chemical | 2023/03/06 | Notification|CEP granted|06/03/2023; New application|CEP granted|13/07/2022 |
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2932 | Rivaroxaban | CIPLA LIMITED Mumbai IN | 100006004;100018147 | R0-CEP 2021-278 - Rev 00 | 2023/03/06 | Valid | 06/03/2028 | Chemical | 2023/03/06 | New application|CEP granted|06/03/2023 | |
2768 | Fluticasone furoate | CORAL DRUGS PRIVATE LIMITED New Delhi IN | 100019182;100042823 | R0-CEP 2022-018 - Rev 00 | 2023/03/06 | Valid | 06/03/2028 | Chemical | 2023/03/06 | New application|CEP granted|06/03/2023 | |
714 | Doxorubicin Hydrochloride | TRANSO-PHARM HANDELS GMBH Siek DE | 100018331;100027110 | R1-CEP 2004-059 - Rev 03 | 2023/03/06 | Valid | Chemical | 2023/03/06 | Notification|CEP granted|06/03/2023; Notification|Rejected|09/11/2022 |
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550 | Diazoxide | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | 100011732;100018657 | R0-CEP 2021-065 - Rev 00 | 2023/03/03 | Valid | 03/03/2028 | Chemical | 2023/03/03 | New application|CEP granted|03/03/2023 | |
1755 | Ketorolac trometamol | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | R1-CEP 2014-369 - Rev 01 | 2023/03/03 | Valid | Chemical | 2023/03/03 | Minor revision|CEP granted|03/03/2023; Renewal|CEP granted|02/02/2022 |
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391 | Furosemide | MANGALAM DRUGS & ORGANICS LTD. Mumbai IN | R0-CEP 2019-063 - Rev 01 | 2023/03/02 | Valid | 07/09/2026 | Chemical | 2023/03/02 | Major revision|CEP granted|02/03/2023 | ||
2445 | Adapalene | BAL PHARMA LIMITED Bangalore IN | 100016398;100041736 | R1-CEP 2016-309 - Rev 00 | 2023/03/02 | Valid | Chemical | 2023/03/02 | Renewal|CEP granted|02/03/2023 | ||
1829 | Horse-chestnut dry extract, standardised, DER 4-6:1 | SCHWABE EXTRACTA GMBH & CO. KG Karlsruhe DE | 100021578;100030272 | R1-CEP 2017-086 - Rev 00 | 2023/03/02 | Valid | Herbal | 2024/03/21 | Notification|Accepted - CEP remains valid|21/03/2024; Monograph revision|Accepted - CEP remains valid|28/08/2023; Renewal|CEP granted|02/03/2023; Minor revision|Accepted - CEP remains valid|09/11/2021; Minor revision|CEP granted|30/04/2020 |
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1765 | Salmeterol xinafoate, Process I | HOVIONE FARMACIENCIA S.A. Loures PT | 100001467;100000315 | R1-CEP 2017-055 - Rev 01 | 2023/03/01 | Valid | Chemical | 2023/03/01 | Minor revision|CEP granted|01/03/2023; Renewal|CEP granted|19/09/2022 |
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513 | Miconazole nitrate | JANSSEN PHARMACEUTICA NV Beerse BE | 100000625;100005958 | R2-CEP 1995-008 - Rev 04 | 2023/03/01 | Valid | Chemical | 2023/09/21 | Notification|Accepted - CEP remains valid|21/09/2023; Administrative procedure|CEP granted|01/03/2023; Minor revision|CEP granted|09/12/2022 |
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1368 | Ramipril, RMP | EGIS Pharmaceuticals PLC Budapest HU | 100001091;100001662 | R0-CEP 2020-284 - Rev 01 | 2023/02/28 | Valid | 19/03/2026 | Chemical | 2023/02/28 | Notification|CEP granted|28/02/2023; New application|CEP granted|19/03/2021 |
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2306 | Gemcitabine hydrochloride, GA process | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | R0-CEP 2022-499 - Rev 00 | 2023/02/28 | Valid | 28/02/2028 | Chemical | 2023/02/28 | New application|CEP granted|28/02/2023 | |
2306 | Gemcitabine hydrochloride | JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD. Lianyungang City CN | R1-CEP 2017-076 - Rev 00 | 2023/02/28 | Valid | Chemical | 2023/02/28 | Renewal|CEP granted|28/02/2023 | |||
2606 | Tadalafil, Process II | MYLAN LABORATORIES LIMITED Hyderabad IN | 100011537;100018667 | R0-CEP 2019-201 - Rev 01 | 2023/02/27 | Valid | 20/12/2024 | Chemical | 2023/02/27 | Minor revision|CEP granted|27/02/2023 | |
662 | Daunorubicin Hydrochloride | DZD (HEZE) PHARMACEUTICAL CO., LTD. Heze City CN | 100039412;100062056 | R1-CEP 2016-253 - Rev 01 | 2023/02/27 | Valid | Chemical | 2023/02/27 | Monograph revision|CEP granted|27/02/2023; Renewal|CEP granted|19/10/2022 |