| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2059 | Pravastatin sodium | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2003-073 - Rev 04 | 2025/02/28 | Valid | Chemical | 2025/02/28 | Notification|CEP granted|28/02/2025; Minor revision|Accepted - CEP remains valid|25/10/2024; Minor revision|CEP granted|25/02/2022; Minor revision|Accepted - CEP remains valid|29/09/2020 |
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| 1241 | Mefloquine hydrochloride | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2011-099 - Rev 05 | 2025/02/28 | Valid | Chemical | 2025/02/28 | Minor revision|CEP granted|28/02/2025; Monograph revision|CEP granted|11/07/2024; Minor revision|Accepted - CEP remains valid|18/12/2023; Monograph revision|CEP granted|12/04/2023; Minor revision|Accepted - CEP remains valid|15/07/2022; Minor revision|CEP granted|30/03/2021 |
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| 551 | Dihydroergotamine mesilate | TAPI CZECH INDUSTRIES S.R.O. Opava CZ | 100051642;100090678 | CEP 2005-107 - Rev 03 | 2025/02/28 | Valid | Chemical | 2025/02/28 | Minor revision|CEP granted|28/02/2025; Minor revision|CEP granted|07/11/2022; Minor revision|Accepted - CEP remains valid|25/11/2021; Minor revision|Accepted - CEP remains valid|15/12/2020 |
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| 2232 | Losartan potassium | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2009-133 - Rev 09 | 2025/02/28 | Valid | Chemical | 2025/06/19 | Minor revision|Accepted - CEP remains valid|19/06/2025; Minor revision|CEP granted|28/02/2025; Minor revision|CEP granted|23/03/2023; Minor revision|Accepted - CEP remains valid|04/01/2023; Minor revision|Accepted - CEP remains valid|30/08/2022; Notification|CEP granted|07/07/2022; Major revision|CEP granted|03/01/2022; Minor revision|CEP granted|15/01/2021; Minor revision|CEP granted|11/06/2020 |
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| 2541 | Quetiapine Fumarate, Standard and milled | Moehs Iberica S.L. Rubi ES | 100029092;100068825 | CEP 2018-277 - Rev 03 | 2025/02/28 | Valid | Chemical | 2025/03/03 | Renewal|CEP granted|03/03/2025; Major revision|CEP granted|21/11/2024; Minor revision|CEP granted|03/05/2021 |
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| 2191 | Atorvastatin calcium | ARCH PHARMALABS LIMITED Mumbai IN | 100011823;100095249 | CEP 2019-129 - Rev 03 | 2025/02/28 | Valid | 02/12/2026 | Chemical | 2025/03/03 | Notification|CEP granted|03/03/2025; Minor revision|CEP granted|09/02/2024; Notification|CEP granted|04/12/2023; Minor revision|Accepted - CEP remains valid|03/11/2022; Monograph revision|Accepted - CEP remains valid|22/08/2022 |
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| 140 | Ethinylestradiol, Micronised, non-micronised | QINHUANGDAO ZIZHU PHARMACEUTICAL CO., LTD. Qinhuangdao City CN | 100016470;100025257 | CEP 2011-220 - Rev 02 | 2025/02/28 | Valid | Chemical | 2025/08/25 | Notification|Accepted - CEP remains valid|25/08/2025; Notification|CEP granted|03/03/2025; Minor revision|CEP granted|25/08/2020 |
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| 1146 | Roxithromycin | HEC PHARM CO., LTD. Yidu City CN | 100017619;100026390 | CEP 2018-207 - Rev 01 | 2025/02/28 | Valid | Chemical | 2025/03/03 | Renewal|CEP granted|03/03/2025 | ||
| 2591 | Celecoxib | AARTI DRUGS LIMITED Mumbai IN | 100014953;100023652 | CEP 2014-199 - Rev 01 | 2025/02/28 | Valid | Chemical | 2025/03/03 | Minor revision|CEP granted|03/03/2025; Renewal|CEP granted|23/08/2021 |
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| 1745 | Carvedilol, Process-II, micronised | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-534 - Rev 00 | 2025/02/28 | Valid | 28/02/2030 | Chemical | 2025/03/03 | New application|CEP granted|03/03/2025 | |
| 1275 | Ursodeoxycholic acid | SUZHOU TIANLU BIO-PHARMACEUTICAL CO. LTD. Suzhou CN | 100018634;100027427 | CEP 2023-317 - Rev 01 | 2025/02/28 | Valid | 07/02/2030 | Chemical | 2025/03/03 | Administrative procedure|CEP granted|03/03/2025; New application|CEP granted|07/02/2025 |
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| 2743 | Zoledronic acid monohydrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2020-018 - Rev 02 | 2025/02/28 | Valid | 11/06/2026 | Chemical | 2025/03/03 | Minor revision|CEP granted|03/03/2025; Notification|Rejected|27/01/2025; Notification|CEP granted|14/01/2022; New application|CEP granted|11/06/2021 |
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| 3035 | Tapentadol hydrochloride | YICHANG HUMANWELL PHARMACEUTICAL CO., LTD. Yichang CN | 100023502;100032643 | CEP 2024-119 - Rev 00 | 2025/02/28 | Valid | 28/02/2030 | Chemical | 2025/03/03 | New application|CEP granted|03/03/2025 | |
| 353 | Prednisolone, Micronised | SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN | 100018972;100027743 | CEP 2020-194 - Rev 01 | 2025/02/28 | Valid | 23/06/2027 | Chemical | 2025/03/03 | Minor revision|CEP granted|03/03/2025; New application|CEP granted|23/06/2022 |
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| 38 | Levodopa, Enzymatic process | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2013-293 - Rev 02 | 2025/02/27 | Valid | Chemical | 2025/02/27 | Notification|CEP granted|27/02/2025; Notification|CEP granted|22/11/2021; Renewal|CEP granted|26/05/2020 |
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| 1450 | Mupirocin, Isobutyl acetate process | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2017-011 - Rev 01 | 2025/02/27 | Valid | Chemical | 2025/02/27 | Notification|CEP granted|27/02/2025; Minor revision|Accepted - CEP remains valid|28/08/2023; Renewal|CEP granted|02/06/2022; Notification|CEP granted|23/11/2021; Minor revision|Accepted - CEP remains valid|13/08/2021; Minor revision|Accepted - CEP remains valid|09/10/2020 |
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| 645 | Tobramycin | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1997-046 - Rev 07 | 2025/02/27 | Valid | Chemical | 2025/02/27 | Notification|CEP granted|27/02/2025; Minor revision|Accepted - CEP remains valid|17/11/2023; Minor revision|CEP granted|08/12/2021; Minor revision|Accepted - CEP remains valid|07/12/2020 |
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| 485 | Dihydrostreptomycin sulfate for veterinary use | North China Pharmaceutical Huasheng Co., Ltd. Shijiazhuang CN | 100021261;100029965 | CEP 2001-393 - Rev 08 | 2025/02/27 | Valid | Chemical | 2025/02/27 | Administrative procedure|CEP granted|27/02/2025; Minor revision|CEP granted|13/02/2025; Minor revision|CEP granted|28/06/2023; Minor revision|Accepted - CEP remains valid|13/01/2021 |
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| 394 | Hydrochlorothiazide | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2004-149 - Rev 08 | 2025/02/26 | Valid | Chemical | 2025/02/26 | Minor revision|CEP granted|26/02/2025; Minor revision|CEP granted|03/10/2022; Notification|CEP granted|22/11/2021; Minor revision|Accepted - CEP remains valid|26/07/2021; Notification|Accepted - CEP remains valid|05/01/2021 |
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| 2284 | Calcipotriol monohydrate | CERBIOS-PHARMA SA Barbengo CH | 100015546;100024284 | CEP 2016-206 - Rev 02 | 2025/02/26 | Valid | Chemical | 2025/02/26 | Minor revision|CEP granted|26/02/2025; Minor revision|CEP granted|30/11/2022; Renewal|CEP granted|23/09/2022; Administrative procedure|CEP granted|24/11/2021; Minor revision|CEP granted|08/11/2021 |
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