| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2782 | Vardenafil hydrochloride trihydrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2015-329 - Rev 02 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Notification|CEP granted|30/07/2024; Renewal|CEP granted|10/12/2021 |
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| 2617 | Aripiprazole | NIFTY LABS PRIVATE LIMITED Hyderabad IN | 100014767;100042749 | CEP 2017-198 - Rev 04 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Renewal|CEP granted|16/07/2024; Notification|CEP granted|16/08/2022; Monograph revision|CEP granted|06/07/2021 |
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| 2988 | Fingolimod hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2019-076 - Rev 04 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Renewal|CEP granted|30/07/2025; Notification|CEP granted|30/07/2024; Monograph revision|Accepted - CEP remains valid|12/03/2024; Notification|CEP granted|28/09/2021 |
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| 2331 | Rabeprazole sodium hydrate | NIFTY LABS PRIVATE LIMITED Hyderabad IN | 100014767;100042749 | CEP 2020-166 - Rev 03 | 2025/09/24 | Valid | 03/09/2026 | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Minor revision|CEP granted|28/03/2024; Notification|CEP granted|16/08/2022; New application|CEP granted|03/09/2021 |
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| 254 | Adrenaline tartrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2015-013 - Rev 03 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Notification|CEP granted|29/07/2024; Notification|CEP granted|28/09/2021; Renewal|CEP granted|15/06/2021 |
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| 2541 | Quetiapine Fumarate, Process-I | NIFTY LABS PRIVATE LIMITED Hyderabad IN | 100014767;100042749 | CEP 2021-187 - Rev 01 | 2025/09/24 | Valid | 28/02/2029 | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; New application|CEP granted|28/02/2024 |
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| 2229 | Enrofloxacin for veterinary use, Process II | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2023-424 - Rev 02 | 2025/09/24 | Valid | 14/02/2029 | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Notification|CEP granted|29/07/2024; New application|CEP granted|14/02/2024 |
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| 1250 | Omega-3-acid ethyl esters 90, With alpha-tocopherol 2 | SHANDONG TENMORE TRADING CO., LTD. Linyi CN | 100051725;100090854 | CEP 2025-341 - Rev 00 | 2025/09/24 | Valid | 24/09/2030 | Chemical | 2025/09/24 | New application|CEP granted|24/09/2025 | |
| 2125 | Doxazosin mesilate | NIFTY LABS PRIVATE LIMITED Hyderabad IN | 100014767;100042749 | CEP 2022-257 - Rev 01 | 2025/09/24 | Valid | 15/04/2029 | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; New application|CEP granted|15/04/2024 |
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| 2932 | Rivaroxaban | NIFTY LABS PRIVATE LIMITED Hyderabad IN | 100014767;100042749 | CEP 2022-375 - Rev 01 | 2025/09/24 | Valid | 17/05/2029 | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; New application|CEP granted|17/05/2024 |
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| 2541 | Quetiapine Fumarate, Process II | NIFTY LABS PRIVATE LIMITED Hyderabad IN | 100014767;100042749 | CEP 2021-289 - Rev 04 | 2025/09/24 | Valid | 01/04/2027 | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Minor revision|CEP granted|14/05/2024; Minor revision|CEP granted|15/06/2023; Notification|CEP granted|16/08/2022; New application|CEP granted|01/04/2022 |
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| 253 | Ascorbic acid | Luwei Pharmaceutical Group Co., Ltd Zibo CN | 100049996;100087293 | CEP 2023-408 - Rev 00 | 2025/09/24 | Valid | 24/09/2030 | Chemical and TSE | 2025/09/24 | New application|CEP granted|24/09/2025 | |
| 2230 | Latanoprost | CAYMAN PHARMA S.R.O. Neratovice CZ | 100013822;100019767 | CEP 2023-147 - Rev 01 | 2025/09/23 | Valid | 10/06/2030 | Chemical | 2025/09/23 | Administrative procedure|CEP granted|23/09/2025; New application|CEP granted|10/06/2025 |
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| 2787 | Esomeprazole magnesium dihydrate, Micronised 1 and Micronised 2 | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 2014-077 - Rev 02 | 2025/09/23 | Valid | Chemical | 2025/09/23 | Minor revision|CEP granted|23/09/2025; Minor revision|CEP granted|21/11/2024; Renewal|CEP granted|26/08/2021 |
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| 2616 | Topiramate | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2021-419 - Rev 02 | 2025/09/23 | Valid | 24/03/2028 | Chemical | 2025/09/23 | Minor revision|CEP granted|23/09/2025; Minor revision|CEP granted|10/10/2024; New application|CEP granted|24/03/2023 |
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| 2600 | Olmesartan medoxomil | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2012-043 - Rev 05 | 2025/09/23 | Valid | Chemical | 2025/09/23 | Notification|CEP granted|23/09/2025; Notification|CEP granted|22/07/2024; Notification|CEP granted|01/09/2021; Major revision|CEP granted|02/11/2020 |
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| 2787 | Esomeprazole magnesium dihydrate, Micronised, non-micronised | MINAKEM Dunkerque FR | 100032366;100056463 | CEP 2015-086 - Rev 01 | 2025/09/22 | Valid | Chemical | 2025/09/22 | Major revision|CEP granted|22/09/2025; Notification|Accepted - CEP remains valid|15/11/2024; Minor revision|Accepted - CEP remains valid|20/12/2023; Minor revision|Accepted - CEP remains valid|15/07/2022; Minor revision|Accepted - CEP remains valid|26/05/2021; Renewal|CEP granted|31/08/2020 |
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| 1563 | Simvastatin, Ethanol process | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2010-130 - Rev 06 | 2025/09/22 | Valid | Chemical | 2025/09/22 | Notification|CEP granted|22/09/2025; Notification|CEP granted|20/12/2021 |
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| 929 | Loperamide hydrochloride, Micronised | LAKE CHEMICALS PRIVATE LIMITED Bengaluru IN | 100012055;100053935 | CEP 2009-362 - Rev 03 | 2025/09/22 | Valid | Chemical | 2025/09/22 | Minor revision|CEP granted|22/09/2025; Notification|CEP granted|14/02/2023 |
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| 2675 | Irinotecan hydrochloride trihydrate | QILU PHARMACEUTICAL CO., LTD. Jinan CN | 100014051;100061315 | CEP 2016-276 - Rev 02 | 2025/09/22 | Valid | Chemical | 2025/09/22 | Major revision|CEP granted|22/09/2025; Minor revision|Accepted - CEP remains valid|31/01/2025; Minor revision|CEP granted|26/06/2024; Minor revision|Accepted - CEP remains valid|26/02/2024; Renewal|CEP granted|25/08/2022; Notification|Accepted - CEP remains valid|28/01/2022; Notification|Accepted - CEP remains valid|10/11/2021; Notification|CEP granted|16/09/2021; Minor revision|CEP granted|19/06/2020 |
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