| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2857 | Trazodone hydrochloride | PIRAMAL PHARMA LIMITED Digwal Village IN | 100036948;100058375 | CEP 2022-166 - Rev 02 | 2025/01/29 | Valid | 01/08/2028 | Chemical | 2025/01/29 | Administrative procedure|CEP granted|29/01/2025; Notification|CEP granted|20/01/2025; New application|CEP granted|01/08/2023 |
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| 1199 | Dipyridamole | SOCIETÀ ITALIANA MEDICINALI SCANDICCI S.I.M.S. S.R.L Reggello IT | 100012503;100022784 | CEP 2004-204 - Rev 04 | 2025/01/27 | Valid | Chemical | 2025/01/27 | Minor revision|CEP granted|27/01/2025; Notification|Rejected|25/09/2023 |
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| 260 | Amoxicillin trihydrate, Micronised, normal and high density powder | ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN | 100022945;100052547 | CEP 2006-039 - Rev 03 | 2025/01/27 | Valid | Chemical | 2025/01/27 | Notification|CEP granted|27/01/2025; Notification|Accepted - CEP remains valid|13/06/2024; Minor revision|CEP granted|16/10/2020 |
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| 2125 | Doxazosin mesilate, Form-II | CHEMISCHE FABRIK BERG GMBH Bitterfeld-Wolfen DE | 100014200;100020038 | CEP 2024-489 - Rev 00 | 2025/01/27 | Valid | 27/01/2030 | Chemical | 2025/01/27 | New application|CEP granted|27/01/2025 | |
| 2573 | Candesartan cilexetil, Form I | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2011-248 - Rev 03 | 2025/01/27 | Valid | Chemical | 2025/01/27 | Notification|CEP granted|27/01/2025; Notification|Accepted - CEP remains valid|04/12/2023; Notification|CEP granted|22/11/2021 |
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| 2631 | Rosuvastatin calcium, Process-III, Amorphous | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2024-354 - Rev 00 | 2025/01/24 | Valid | 24/01/2030 | Chemical | 2025/01/24 | New application|CEP granted|24/01/2025 | |
| 2933 | Deferasirox | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2021-111 - Rev 01 | 2025/01/24 | Valid | 11/04/2028 | Chemical | 2025/01/24 | Notification|CEP granted|24/01/2025; Minor revision|Accepted - CEP remains valid|10/07/2024; Notification|Accepted - CEP remains valid|02/10/2023; New application|CEP granted|11/04/2023 |
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| 2011 | Calcipotriol | CHONGQING HUAPONT SHENGCHEM PHARMACEUTICAL CO., LTD. Chongqing CN | 100024073;100062002 | CEP 2024-219 - Rev 00 | 2025/01/24 | Valid | 24/01/2030 | Chemical | 2025/01/24 | New application|CEP granted|24/01/2025 | |
| 2449 | Docetaxel trihydrate | FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN | 100011513;100018607 | CEP 2011-189 - Rev 05 | 2025/01/24 | Valid | Chemical | 2025/01/24 | Major revision|CEP granted|24/01/2025; Minor revision|Accepted - CEP remains valid|22/08/2024; Notification|Accepted - CEP remains valid|18/08/2023; Minor revision|CEP granted|16/02/2023; Notification|Rejected|12/01/2023; Minor revision|CEP granted|07/02/2022; Notification|CEP granted|16/12/2020 |
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| 668 | Flucloxacillin sodium monohydrate, Powder and compacted | FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT | 100015105;100057989 | CEP 1996-054 - Rev 11 | 2025/01/24 | Valid | Chemical | 2025/01/24 | Minor revision|CEP granted|24/01/2025; Monograph revision|CEP granted|18/05/2022; Notification|CEP granted|11/02/2021 |
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| 989 | Cefotaxime sodium, Sterile | NECTAR LIFESCIENCES LIMITED Tehsil Dera Bassi IN | 100019097;100029430 | CEP 2011-226 - Rev 01 | 2025/01/23 | Suspended by EDQM GMP non-compliance | 2025/04/07 | Chemical | 2025/01/23 | Minor revision|CEP granted|23/01/2025 | |
| 455 | Citric acid, non-micronised and micronised | JUNGBUNZLAUER LADENBURG GMBH Ladenburg DE | 100014785;100073136 | CEP 2016-005 - Rev 03 | 2025/01/23 | Valid | Chemical | 2025/09/19 | Minor revision|Accepted - CEP remains valid|19/09/2025; Administrative procedure|CEP granted|23/01/2025; Minor revision|CEP granted|03/01/2025; Notification|CEP granted|28/08/2024; Renewal|CEP granted|18/07/2022; Notification|Accepted - CEP remains valid|08/01/2021 |
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| 2406 | Anastrozole | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2014-099 - Rev 02 | 2025/01/23 | Valid | Chemical | 2025/08/29 | Minor revision|Accepted - CEP remains valid|29/08/2025; Notification|CEP granted|23/01/2025; Minor revision|Accepted - CEP remains valid|14/06/2024; Minor revision|Accepted - CEP remains valid|28/10/2022; Notification|CEP granted|20/12/2021; Renewal|CEP granted|16/07/2020 |
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| 906 | Glipizide | SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN | 100015104;100023787 | CEP 2014-070 - Rev 01 | 2025/01/23 | Valid | Chemical | 2025/01/23 | Minor revision|CEP granted|23/01/2025; Renewal|CEP granted|25/03/2021 |
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| 2423 | Valsartan, Micronised and non-micronised | MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN | 100018316;100027671 | CEP 2018-275 - Rev 04 | 2025/01/23 | Valid | Chemical | 2025/01/23 | Renewal|CEP granted|23/01/2025; Minor revision|CEP granted|24/08/2023; Minor revision|CEP granted|18/11/2022; Minor revision|CEP granted|24/09/2021 |
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| 2582 | Donepezil hydrochloride, Monohydrate | SYNTHIMED LABS PRIVATE LIMITED Derabassi IN | 100052287;100092080 | CEP 2021-116 - Rev 03 | 2025/01/23 | Valid | 19/10/2027 | Chemical | 2025/01/23 | Minor revision|CEP granted|23/01/2025; Minor revision|CEP granted|05/09/2024; Monograph revision|CEP granted|15/12/2023; New application|CEP granted|19/10/2022 |
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| 2573 | Candesartan cilexetil, Form I - process 2 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2020-164 - Rev 02 | 2025/01/23 | Valid | Chemical | 2025/09/15 | Renewal|Accepted - CEP remains valid|15/09/2025; Notification|CEP granted|23/01/2025; Notification|Accepted - CEP remains valid|04/12/2023; Notification|Accepted - CEP remains valid|01/04/2022; Notification|CEP granted|22/11/2021; New application|CEP granted|10/11/2020 |
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| 2849 | Hydroxychloroquine sulfate | PORTON PHARMA SOLUTIONS LTD. Changshou CN | 100018751;100027547 | CEP 2022-416 - Rev 00 | 2025/01/23 | Valid | 23/01/2030 | Chemical | 2025/10/13 | Notification|Accepted - CEP remains valid|13/10/2025; New application|CEP granted|23/01/2025 |
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| 937 | Minoxidil | SONIA ORGANICS Bengaluru IN | 100046888;100077397 | CEP 2022-331 - Rev 00 | 2025/01/23 | Valid | 23/01/2030 | Chemical | 2025/01/23 | New application|CEP granted|23/01/2025 | |
| 2119 | Venlafaxine hydrochloride | ATUL BIOSCIENCE LIMITED Ambernath (East) IN | 100044514;100086818 | CEP 2022-447 - Rev 01 | 2025/01/23 | Valid | 24/04/2029 | Chemical | 2025/01/23 | Minor revision|CEP granted|23/01/2025; New application|CEP granted|24/04/2024 |
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