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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2254 | Moxifloxacin hydrochloride, Monohydrate | ARAGEN LIFE SCIENCES LIMITED Hyderabad IN | 100030840;100052317 | CEP 2014-101 - Rev 02 | 2023/11/23 | Valid | Chemical | 2023/11/23 | Minor revision|CEP granted|23/11/2023; Minor revision|CEP granted|20/06/2023; Minor revision|Accepted - CEP remains valid|25/01/2023; Renewal|CEP granted|27/07/2021; Minor revision|CEP granted|28/05/2021 |
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1651 | Clarithromycin | MYLAN LABORATORIES LIMITED Hyderabad IN | 100011537;100018667 | CEP 2005-266 - Rev 05 | 2023/11/23 | Valid | Chemical | 2023/11/23 | Major revision|CEP granted|23/11/2023; Minor revision|Accepted - CEP remains valid|14/01/2021 |
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1425 | Fosfomycin trometamol | LABIANA PHARMACEUTICALS, S.L.U. Corbera de Llobregat ES | 100000356;100010380 | CEP 2012-265 - Rev 04 | 2023/11/23 | Valid | Chemical | 2023/11/23 | Administrative procedure|CEP granted|23/11/2023; Notification|CEP granted|24/10/2023; Notification|CEP granted|17/12/2021; Minor revision|CEP granted|18/10/2021; Minor revision|Accepted - CEP remains valid|07/04/2020 |
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1420 | Enalapril maleate | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN | 100011833;100018698 | CEP 2000-053 - Rev 07 | 2023/11/23 | Valid | Chemical | 2023/11/23 | Minor revision|CEP granted|23/11/2023; Minor revision|CEP granted|06/12/2022; Minor revision|Accepted - CEP remains valid|09/10/2020 |
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. | Calf Thymus peptide solution | SANORELL PHARMA GMBH Eutingen im Gäu DE | 100041278;100075148 | CEP 2001-139 - Rev 02 | 2023/11/23 | Valid | TSE | 2023/11/23 | Notification|CEP granted|23/11/2023; Transfer of holdership|CEP granted|11/05/2022 |
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3087 | Ticagrelor | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | CEP 2021-225 - Rev 00 | 2023/11/23 | Valid | 23/11/2028 | Chemical | 2023/11/23 | New application|CEP granted|23/11/2023 | |
2598 | Levofloxacin hemihydrate, Process II | QUIMICA SINTETICA S.A. Alcala De Henares ES | 100012121;100019020 | CEP 2021-284 - Rev 01 | 2023/11/23 | Valid | 14/02/2027 | Chemical | 2023/11/23 | Minor revision|CEP granted|23/11/2023; Minor revision|Accepted - CEP remains valid|13/06/2022; Notification|Accepted - CEP remains valid|22/03/2022; New application|CEP granted|14/02/2022 |
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2254 | Moxifloxacin hydrochloride | ZHEJIANG NHU COMPANY LTD. Shaoxing City CN | 100047413;100085979 | CEP 2021-411 - Rev 00 | 2023/11/23 | Valid | 23/11/2028 | Chemical | 2023/11/23 | New application|CEP granted|23/11/2023 | |
2230 | Latanoprost | KYOWA PHARMA CHEMICAL CO., LTD. Takaoka JP | 100012459;100023387 | CEP 2022-107 - Rev 00 | 2023/11/23 | Valid | 23/11/2028 | Chemical | 2023/11/23 | New application|CEP granted|23/11/2023 | |
2766 | Exemestane, Micronised (Form A), non-micronised | SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN | 100014777;100050265 | CEP 2016-156 - Rev 01 | 2023/11/23 | Valid | Chemical | 2023/11/23 | Minor revision|CEP granted|23/11/2023; Renewal|CEP granted|30/05/2022; Minor revision|CEP granted|13/01/2021; Monograph revision|CEP granted|23/04/2020 |
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663 | Dicloxacillin sodium | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2010-177 - Rev 02 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Notification|CEP granted|21/11/2023; Minor revision|Accepted - CEP remains valid|06/07/2022; Minor revision|Accepted - CEP remains valid|18/03/2021 |
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2260 | Oxacillin sodium monohydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2007-349 - Rev 05 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Notification|CEP granted|21/11/2023; Notification|Accepted - CEP remains valid|13/02/2023; Minor revision|Accepted - CEP remains valid|16/06/2022; Minor revision|Accepted - CEP remains valid|19/10/2021 |
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260 | Amoxicillin trihydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2007-147 - Rev 04 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Notification|CEP granted|21/11/2023; Notification|Accepted - CEP remains valid|13/02/2023; Minor revision|Accepted - CEP remains valid|16/06/2022; Minor revision|Accepted - CEP remains valid|18/10/2021 |
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2541 | Quetiapine Fumarate | MEGAFINE PHARMA (P) LIMITED Mumbai IN | 100011550;100021133 | CEP 2014-198 - Rev 01 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Minor revision|CEP granted|21/11/2023 | ||
168 | Ampicillin trihydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2007-358 - Rev 04 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Notification|CEP granted|21/11/2023; Minor revision|Accepted - CEP remains valid|23/06/2022; Minor revision|Accepted - CEP remains valid|26/05/2021; Minor revision|Accepted - CEP remains valid|09/03/2021 |
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2287 | Fluconazole | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2007-071 - Rev 05 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Notification|CEP granted|21/11/2023; Minor revision|CEP granted|18/08/2023; Monograph revision|Accepted - CEP remains valid|02/05/2023; Minor revision|Accepted - CEP remains valid|24/02/2022; Minor revision|CEP granted|24/06/2020 |
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2346 | Flucloxacillin magnesium octahydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2008-011 - Rev 03 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Notification|CEP granted|21/11/2023; Minor revision|Accepted - CEP remains valid|08/08/2022 |
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1359 | Pivmecillinam hydrochloride | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2007-229 - Rev 04 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Notification|CEP granted|21/11/2023; Minor revision|Accepted - CEP remains valid|07/06/2022; Minor revision|Accepted - CEP remains valid|25/02/2021 |
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668 | Flucloxacillin sodium monohydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2003-055 - Rev 10 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Notification|CEP granted|21/11/2023; Notification|Accepted - CEP remains valid|13/02/2023; Monograph revision|CEP granted|17/06/2022; Minor revision|Accepted - CEP remains valid|24/09/2021; Minor revision|Accepted - CEP remains valid|26/05/2021; Minor revision|Accepted - CEP remains valid|24/09/2020 |
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577 | Amoxicillin sodium, Sterile | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2008-002 - Rev 02 | 2023/11/21 | Valid | Chemical | 2023/11/21 | Notification|CEP granted|21/11/2023; Minor revision|Accepted - CEP remains valid|08/02/2023 |