| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 20 | Dextromethorphan hydrobromide monohydrate | MALLADI DRUGS AND PHARMACEUTICALS LIMITED Renigunta IN | 100017917;100061921 | CEP 2018-133 - Rev 02 | 2025/03/17 | Valid | Chemical | 2025/03/18 | Renewal|CEP granted|18/03/2025; Monograph revision|CEP granted|28/06/2024 |
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| 678 | Sodium valproate | ASSURGEN PHARMA PVT LTD Lalamkoduru Village IN | 100048048;100079469 | CEP 2020-373 - Rev 01 | 2025/03/17 | Valid | 13/09/2026 | Chemical | 2025/03/18 | Minor revision|CEP granted|18/03/2025; Minor revision|Rejected|29/10/2024; New application|CEP granted|13/09/2021 |
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| 464 | Amitriptyline hydrochloride | DIPHARMA FRANCIS S.R.L. Baranzate IT | 100014675;100030401 | CEP 2013-281 - Rev 01 | 2025/03/17 | Valid | Chemical | 2025/03/18 | Minor revision|CEP granted|18/03/2025; Renewal|CEP granted|23/03/2021 |
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| 673 | Medroxyprogesterone acetate, Micronised, Sterile | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2023-423 - Rev 00 | 2025/03/17 | Valid | 17/03/2030 | Chemical | 2025/03/18 | New application|CEP granted|18/03/2025 | |
| 1248 | Norfloxacin, Product code 312025 | KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI | 100000627;100009540 | CEP 2021-141 - Rev 02 | 2025/03/17 | Valid | 20/12/2027 | Chemical | 2025/03/18 | Minor revision|CEP granted|18/03/2025; Minor revision|Accepted - CEP remains valid|13/08/2024; Minor revision|CEP granted|06/02/2024; New application|CEP granted|20/12/2022 |
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| 426 | Polysorbate 20 | KOLB DISTRIBUTION LTD. Hedingen CH | 100040656;100066825 | CEP 2023-322 - Rev 00 | 2025/03/17 | Valid | 17/03/2030 | Chemical | 2025/03/18 | New application|CEP granted|18/03/2025 | |
| 2933 | Deferasirox | Ulkar Kimya Sanayii Ve Ticaret Anonim Sirketi Istanbul TR | 100022492;100082995 | CEP 2023-310 - Rev 00 | 2025/03/17 | Valid | 17/03/2030 | Chemical | 2025/03/18 | New application|CEP granted|18/03/2025 | |
| 179 | Erythromycin, Process 2 | SM BIOMED SDN BHD Sungai Petani MY | 100018119;100026902 | CEP 2020-007 - Rev 01 | 2025/03/14 | Withdrawn by EDQM GMP non-compliance | 2025/11/14 | Chemical | 2025/03/14 | ||
| 45 | Methyldopa | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-326 - Rev 06 | 2025/03/14 | Valid | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Notification|CEP granted|28/11/2023; Notification|CEP granted|05/01/2022; Minor revision|CEP granted|24/02/2021; Minor revision|CEP granted|06/10/2020 |
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| 2600 | Olmesartan medoxomil | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2012-170 - Rev 02 | 2025/03/14 | Valid | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Notification|CEP granted|25/05/2022; Major revision|Rejected|08/09/2020 |
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| 2232 | Losartan potassium | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2011-105 - Rev 05 | 2025/03/14 | Valid | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Notification|Accepted - CEP remains valid|11/04/2023; Minor revision|Accepted - CEP remains valid|18/07/2022; Minor revision|CEP granted|14/03/2022; Minor revision|Accepted - CEP remains valid|23/03/2021; Minor revision|CEP granted|03/09/2020 |
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| 1789 | Nadolol | EUROAPI GERMANY GmbH Frankfurt am Main DE | 100039255;100061797 | CEP 2010-058 - Rev 03 | 2025/03/14 | Valid | Chemical | 2025/03/14 | Minor revision|CEP granted|14/03/2025; Minor revision|Accepted - CEP remains valid|27/11/2024; Transfer of holdership|CEP granted|10/12/2021 |
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| 68 | Atropine sulfate | SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN | 100011774;100018647 | CEP 2015-317 - Rev 02 | 2025/03/14 | Valid | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Notification|Accepted - CEP remains valid|19/04/2024; Minor revision|Accepted - CEP remains valid|14/12/2023; Notification|Rejected|19/10/2023; Minor revision|CEP granted|10/11/2022; Notification|Rejected|01/08/2022; Renewal|CEP granted|02/11/2021; Administrative procedure|CEP granted|10/11/2020; Minor revision|CEP granted|21/10/2020 |
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| 2598 | Levofloxacin hemihydrate | SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN | 100011774;100018647 | CEP 2019-315 - Rev 01 | 2025/03/14 | Valid | 18/05/2027 | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Minor revision|Accepted - CEP remains valid|28/05/2024; Minor revision|Accepted - CEP remains valid|12/06/2023 |
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| 2606 | Tadalafil | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2013-152 - Rev 03 | 2025/03/14 | Valid | Chemical | 2025/09/17 | Notification|Accepted - CEP remains valid|17/09/2025; Notification|CEP granted|14/03/2025; Minor revision|Accepted - CEP remains valid|16/04/2024; Minor revision|Accepted - CEP remains valid|07/03/2023; Notification|CEP granted|07/03/2022; Minor revision|CEP granted|24/03/2021 |
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| 2988 | Fingolimod hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2018-259 - Rev 05 | 2025/03/14 | Valid | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Renewal|CEP granted|21/10/2024; Monograph revision|CEP granted|05/06/2024; Minor revision|Accepted - CEP remains valid|15/07/2022; Notification|CEP granted|04/02/2022; Minor revision|CEP granted|11/06/2021 |
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| 2779 | Solifenacin succinate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2020-248 - Rev 02 | 2025/03/14 | Valid | 24/11/2026 | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Notification|CEP granted|20/12/2021; New application|CEP granted|24/11/2021 |
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| 2777 | Pregabalin, ID 3636/9111 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2020-375 - Rev 03 | 2025/03/14 | Valid | 01/04/2026 | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Notification|CEP granted|08/02/2024; Notification|CEP granted|20/12/2021; New application|CEP granted|01/04/2021 |
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| 2988 | Fingolimod hydrochloride | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2020-090 - Rev 02 | 2025/03/14 | Valid | 02/07/2026 | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; Monograph revision|Accepted - CEP remains valid|29/04/2024; Minor revision|CEP granted|06/07/2023; New application|CEP granted|02/07/2021 |
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| 2531 | Clopidogrel hydrogen sulfate | SCL LIFESCIENCES LIMITED Sahibzada Ajit Singh Nagar IN | 100011774;100018647 | CEP 2022-148 - Rev 01 | 2025/03/14 | Valid | 31/10/2029 | Chemical | 2025/03/14 | Notification|CEP granted|14/03/2025; New application|CEP granted|31/10/2024 |
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