| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1998 | Nicergoline | CHONGQING QIANTAI PHARMA CO., LTD. Chongqing CN | 100053648;100094867 | CEP 2022-026 - Rev 02 | 2025/03/19 | Valid | 23/06/2028 | Chemical | 2025/03/19 | Transfer of holdership|CEP granted|19/03/2025; Minor revision|CEP granted|23/09/2024; New application|CEP granted|23/06/2023 |
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| 888 | Ciprofloxacin Hydrochloride | UQUIFA MEXICO S.A. DE C.V. Jiutepec MX | 100022026;100030736 | CEP 2004-174 - Rev 06 | 2025/03/19 | Valid | Chemical | 2025/03/19 | Minor revision|CEP granted|19/03/2025; Minor revision|CEP granted|20/03/2024; Notification|Accepted - CEP remains valid|03/02/2023; Minor revision|CEP granted|26/01/2022; Notification|CEP granted|04/06/2021; Minor revision|Accepted - CEP remains valid|08/09/2020 |
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| 45 | Methyldopa | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-182 - Rev 05 | 2025/03/18 | Valid | Chemical | 2025/03/18 | Notification|CEP granted|18/03/2025; Notification|CEP granted|06/06/2024; Notification|CEP granted|24/03/2022; Notification|CEP granted|23/11/2021 |
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| 2604 | Ropinirole hydrochloride | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2017-242 - Rev 02 | 2025/03/18 | Valid | Chemical | 2025/06/02 | Notification|Accepted - CEP remains valid|02/06/2025; Renewal|CEP granted|18/03/2025; Notification|CEP granted|13/12/2022 |
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| 1688 | Articaine hydrochloride | Moehs Iberica S.L. Rubi ES | 100029092;100068825 | CEP 2010-262 - Rev 02 | 2025/03/18 | Valid | Chemical | 2025/03/18 | Minor revision|CEP granted|18/03/2025; Minor revision|CEP granted|24/11/2021 |
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| 38 | Levodopa | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1999-187 - Rev 10 | 2025/03/18 | Valid | Chemical | 2025/03/18 | Notification|CEP granted|18/03/2025; Notification|Accepted - CEP remains valid|06/09/2024; Notification|CEP granted|24/03/2022; Notification|CEP granted|04/02/2022 |
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| 2641 | Dutasteride | SWATI SPENTOSE PRIVATE LIMITED Mumbai IN | 100021605;100052219 | CEP 2022-503 - Rev 00 | 2025/03/18 | Valid | 18/03/2030 | Chemical | 2025/03/18 | New application|CEP granted|18/03/2025 | |
| 1028 | Metoprolol tartrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1998-074 - Rev 13 | 2025/03/18 | Valid | Chemical | 2025/03/18 | Notification|CEP granted|18/03/2025; Notification|Accepted - CEP remains valid|27/08/2024; Minor revision|CEP granted|12/03/2024; Minor revision|CEP granted|24/08/2023; Notification|CEP granted|24/03/2022; Notification|CEP granted|05/01/2022; Minor revision|Accepted - CEP remains valid|06/10/2020 |
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| 573 | Verapamil hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2006-098 - Rev 04 | 2025/03/18 | Valid | Chemical | 2025/03/18 | Notification|CEP granted|18/03/2025; Notification|Accepted - CEP remains valid|03/06/2024; Notification|CEP granted|24/03/2022; Notification|CEP granted|23/02/2022 |
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| 2583 | Montelukast sodium | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2011-131 - Rev 03 | 2025/03/17 | Valid | Chemical | 2025/03/17 | Notification|CEP granted|17/03/2025; Monograph revision|Accepted - CEP remains valid|26/11/2024; Minor revision|CEP granted|24/02/2022; Minor revision|Accepted - CEP remains valid|06/10/2020 |
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| 2703 | Ciclesonide | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2014-090 - Rev 02 | 2025/03/17 | Valid | Chemical | 2025/03/17 | Minor revision|CEP granted|17/03/2025; Notification|Rejected|30/01/2025; Notification|CEP granted|27/10/2022; Renewal|CEP granted|28/06/2021 |
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| 1248 | Norfloxacin, Product code 312008 | KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI | 100000627;100009540 | CEP 2021-140 - Rev 02 | 2025/03/17 | Valid | 20/12/2027 | Chemical | 2025/03/17 | Minor revision|CEP granted|17/03/2025; Minor revision|Accepted - CEP remains valid|31/08/2023; Minor revision|CEP granted|28/03/2024; New application|CEP granted|20/12/2022 |
|
| 2416 | Pramipexole dihydrochloride monohydrate | Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Am Rhein DE | 100000199;100004370 | CEP 2019-186 - Rev 01 | 2025/03/17 | Valid | Chemical | 2025/03/17 | Renewal|CEP granted|17/03/2025; Minor revision|Accepted - CEP remains valid|31/10/2023; Notification|Accepted - CEP remains valid|29/09/2020 |
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| 3046 | Pemetrexed disodium 2.5-hydrate | FARMHISPANIA S.A. Montmeló ES | 100011645;100022190 | CEP 2023-233 - Rev 01 | 2025/03/17 | Valid | 25/09/2029 | Chemical | 2025/03/17 | Minor revision|CEP granted|17/03/2025; New application|CEP granted|25/09/2024 |
|
| 2232 | Losartan potassium, Process 3 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2023-006 - Rev 01 | 2025/03/17 | Valid | 06/07/2028 | Chemical | 2025/05/16 | Minor revision|Accepted - CEP remains valid|16/05/2025; Notification|CEP granted|17/03/2025; New application|CEP granted|06/07/2023 |
|
| 1702 | Naproxen sodium | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2007-047 - Rev 06 | 2025/03/17 | Valid | Chemical | 2025/03/18 | Notification|CEP granted|18/03/2025; Notification|Accepted - CEP remains valid|17/07/2024; Notification|CEP granted|24/03/2022; Notification|CEP granted|23/11/2021 |
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| 1368 | Ramipril, Grade A | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2009-083 - Rev 06 | 2025/03/17 | Valid | Chemical | 2025/07/29 | Minor revision|Accepted - CEP remains valid|29/07/2025; Major revision|CEP granted|18/03/2025; Minor revision|Accepted - CEP remains valid|31/08/2023; Notification|Rejected|27/07/2023; Notification|CEP granted|14/10/2022; Monograph revision|CEP granted|06/12/2021 |
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| 1592 | Ketotifen hydrogen fumarate | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2012-054 - Rev 05 | 2025/03/17 | Valid | Chemical | 2025/03/18 | Minor revision|CEP granted|18/03/2025; Minor revision|CEP granted|29/07/2024; Minor revision|CEP granted|10/06/2021 |
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| 1653 | Potassium clavulanate, diluted, With silicone dioxide in the ratio 1:1 | SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN | 100025540;100034769 | CEP 2011-376 - Rev 03 | 2025/03/17 | Valid | Chemical | 2025/03/18 | Minor revision|CEP granted|18/03/2025; Minor revision|Accepted - CEP remains valid|01/03/2024; Minor revision|Accepted - CEP remains valid|04/10/2022; Minor revision|CEP granted|01/03/2021; Minor revision|Accepted - CEP remains valid|13/02/2020 |
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| 731 | Naproxen | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 1997-064 - Rev 09 | 2025/03/17 | Valid | Chemical | 2025/03/18 | Notification|CEP granted|18/03/2025; Notification|Accepted - CEP remains valid|07/06/2024; Notification|CEP granted|24/03/2022; Notification|CEP granted|23/11/2021 |
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