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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798 | Fusidic acid, Sterile Powder and Sterile Micronized | ERCROS S.A. Aranjuez ES | 100016091;100024873 | CEP 2023-222 - Rev 00 | 2023/09/28 | Valid | 28/09/2028 | Chemical | 2023/09/28 | New application|CEP granted|28/09/2023 | |
2136 | Ritonavir | SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO., LTD. Laogang Town CN | 100032340;100050678 | CEP 2017-229 - Rev 02 | 2023/09/28 | Valid | 12/07/2024 | Chemical | 2023/09/28 | Minor revision|CEP granted|28/09/2023; Minor revision|CEP granted|18/03/2020 |
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2593 | Docetaxel | CHONGQING SINTAHO PHARMACEUTICAL CO., LTD. Maliuzui CN | 100041836;100068984 | CEP 2022-295 - Rev 00 | 2023/09/28 | Valid | 28/09/2028 | Chemical | 2023/09/28 | New application|CEP granted|28/09/2023 | |
1732 | Norgestimate | Industriale Chimica S.R.L. Saronno IT | 100011692;100020331 | CEP 2017-189 - Rev 01 | 2023/09/28 | Valid | Chemical | 2023/09/28 | Renewal|CEP granted|28/09/2023; Minor revision|Accepted - CEP remains valid|01/03/2021; Notification|Accepted - CEP remains valid|06/08/2020 |
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1240 | Mefenamic acid | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100078783 | CEP 2007-011 - Rev 07 | 2023/09/28 | Valid | Chemical | 2023/09/28 | Administrative procedure|CEP granted|28/09/2023; Minor revision|CEP granted|20/09/2023; Minor revision|CEP granted|31/01/2022 |
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2932 | Rivaroxaban | Jiangxi Synergy Pharmaceutical Co., Ltd. Fengxin CN | 100020812;100083553 | CEP 2021-047 - Rev 01 | 2023/09/28 | Valid | 26/07/2028 | Chemical | 2024/02/21 | Minor revision|Accepted - CEP remains valid|21/02/2024; Minor revision|CEP granted|28/09/2023; New application|CEP granted|26/07/2023 |
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47 | Nicotinamide | LONZA GUANGZHOU PHARMACEUTICAL LTD Guangzhou CN | 100024633;100081573 | CEP 2004-110 - Rev 06 | 2023/09/28 | Valid | Chemical | 2023/09/28 | Administrative procedure|CEP granted|28/09/2023; Notification|Accepted - CEP remains valid|16/08/2023; Notification|CEP granted|05/05/2021 |
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1611 | Diosmin | CHENGDU YAZHONG BIO-PHARMACEUTICAL CO., LTD. Pengzhou CN | 100048965;100082078 | CEP 2017-046 - Rev 01 | 2023/09/28 | Valid | Chemical | 2023/09/28 | Minor revision|CEP granted|28/09/2023; Renewal|CEP granted|28/11/2022; Minor revision|Accepted - CEP remains valid|23/06/2020 |
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572 | Timolol maleate, Process II | PCAS Ecully FR | 100011754;100054740 | CEP 2014-300 - Rev 01 | 2023/09/27 | Valid | Chemical | 2023/09/27 | Minor revision|CEP granted|27/09/2023; Notification|Rejected|02/08/2023; Minor revision|Accepted - CEP remains valid|22/12/2021; Renewal|CEP granted|15/02/2021 |
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1422 | Etodolac, Micronised, non-micronised | Zhejiang Chiral Medicine Chemicals Co., Ltd. Hangzhou CN | 100022654;100031335 | CEP 2009-338 - Rev 02 | 2023/09/27 | Valid | Chemical | 2023/09/27 | Notification|CEP granted|27/09/2023; Minor revision|Accepted - CEP remains valid|24/08/2023; Minor revision|Accepted - CEP remains valid|16/09/2022; Minor revision|Accepted - CEP remains valid|12/08/2021 |
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1722 | Flunarizine dihydrochloride | FLEMING LABORATORIES LIMITED Nawabpet Village IN | 100015641;100024384 | CEP 2016-231 - Rev 01 | 2023/09/27 | Valid | Chemical | 2024/06/07 | Renewal|Accepted - CEP remains valid|07/06/2024; Major revision|CEP granted|27/09/2023 |
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114 | Benzylpenicillin sodium, Sterile | SANDOZ GMBH Kundl AT | 100000546;100000450 | CEP 1992-017 - Rev 08 | 2023/09/27 | Valid | Chemical | 2023/09/27 | Minor revision|CEP granted|27/09/2023; Notification|Accepted - CEP remains valid|27/02/2023; Minor revision|Accepted - CEP remains valid|05/07/2022; Notification|Accepted - CEP remains valid|15/12/2020; Minor revision|Accepted - CEP remains valid|30/04/2020 |
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2591 | Celecoxib | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2015-195 - Rev 01 | 2023/09/27 | Valid | Chemical | 2024/01/25 | Major revision|Accepted - CEP remains valid|25/01/2024; Major revision|CEP granted|27/09/2023; Renewal|CEP granted|10/05/2022; Minor revision|CEP granted|17/12/2021; Notification|Rejected|05/11/2021 |
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194 | Sodium dihydrogen phosphate dihydrate | QUALITY CHEMICALS S.L. Esparreguera ES | 100025665;100034895 | CEP 2017-177 - Rev 02 | 2023/09/26 | Valid | Chemical | 2023/09/26 | Renewal|CEP granted|26/09/2023; Minor revision|CEP granted|15/09/2021 |
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401 | Levothyroxine sodium, Code 460 187 - Code 460 132 | SANDOZ GMBH Kundl AT | 100000546;100000450 | CEP 1998-141 - Rev 11 | 2023/09/26 | Valid | Chemical | 2023/09/26 | Notification|CEP granted|26/09/2023; Major revision|CEP granted|02/06/2022 |
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394 | Hydrochlorothiazide, Process III | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2012-044 - Rev 02 | 2023/09/26 | Valid | Chemical | 2023/09/26 | Minor revision|CEP granted|26/09/2023; Major revision|CEP granted|28/11/2022 |
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1075 | Budesonide, Process 2, non-micronised and micronised | FERMION OY Espoo FI | 100011508;100020280 | CEP 2023-192 - Rev 00 | 2023/09/26 | Valid | 26/09/2028 | Chemical | 2023/09/26 | New application|CEP granted|26/09/2023 | |
2097 | Mebeverine hydrochloride | SYNTHOKEM LABS PRIVATE LIMITED Hyderabad IN | 100018775;100027570 | CEP 2021-271 - Rev 00 | 2023/09/25 | Valid | 25/09/2028 | Chemical | 2023/09/25 | New application|CEP granted|25/09/2023 | |
2422 | Oseltamivir phosphate | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2018-046 - Rev 01 | 2023/09/25 | Valid | 28/04/2025 | Chemical | 2023/09/25 | Minor revision|CEP granted|25/09/2023; Minor revision|Accepted - CEP remains valid|05/01/2022 |
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2270 | Sildenafil citrate | Zhejiang Jiuzhou Pharmaceutical Co., Ltd. Taizhou City CN | 100011841;100018560 | CEP 2013-332 - Rev 04 | 2023/09/22 | Valid | Chemical | 2023/09/22 | Administrative procedure|CEP granted|22/09/2023; Notification|CEP granted|21/06/2023; Notification|CEP granted|23/09/2022; Transfer of holdership|CEP granted|19/05/2022; Renewal|CEP granted|22/02/2022 |