| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2630 | Rivastigmine hydrogen tartrate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-003 - Rev 04 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|30/07/2024; Notification|CEP granted|28/09/2021; Minor revision|CEP granted|24/06/2021 |
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| 330 | Gelatin, Caustic and lime hide gelatin | GELITA AG Eberbach DE | 100012955;100080863 | CEP 2021-504 - Rev 01 | 2025/09/25 | Valid | 02/06/2027 | TSE | 2025/09/25 | Transfer of holdership|CEP granted|25/09/2025; New application|CEP granted|02/06/2022 |
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| 2606 | Tadalafil | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2012-021 - Rev 04 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|31/07/2024 |
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| 930 | Lysine Hydrochloride | SHANGHAI PLUMINO AMINO ACID CO., LTD. Shanghai CN | 100025187;100034386 | CEP 2012-007 - Rev 01 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Minor revision|CEP granted|25/09/2025; Notification|Accepted - CEP remains valid|07/05/2024; Minor revision|Accepted - CEP remains valid|11/08/2023; Notification|Accepted - CEP remains valid|11/02/2022; Minor revision|Accepted - CEP remains valid|16/12/2021 |
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| 312 | Betamethasone, Micronised | MSD EUROPE BELGIUM Watermael-Boitsfort BE | 100049238;100083482 | CEP 2012-214 - Rev 01 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Minor revision|CEP granted|25/09/2025 | ||
| 1765 | Salmeterol xinafoate | MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN | 100014822;100073679 | CEP 2010-097 - Rev 02 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Minor revision|CEP granted|25/09/2025; Minor revision|Accepted - CEP remains valid|27/11/2020; Notification|Rejected|06/10/2020 |
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| 873 | Amidotrizoic Acid Dihydrate | JUSTESA IMAGEN, S.A.U. Coslada ES | 100000769;100004566 | CEP 1999-181 - Rev 04 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Minor revision|CEP granted|25/09/2025; Minor revision|Accepted - CEP remains valid|31/10/2024 |
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| 2629 | Rivastigmine | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2012-304 - Rev 03 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Notification|CEP granted|25/09/2025; Notification|CEP granted|30/07/2024; Notification|CEP granted|28/09/2021 |
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| 921 | Ketoconazole | DERIVADOS QUIMICOS S.A. Alcantarilla ES | 100011657;100020423 | CEP 2016-102 - Rev 04 | 2025/09/25 | Valid | Chemical | 2025/09/25 | Minor revision|CEP granted|25/09/2025; Renewal|CEP granted|23/10/2023; Minor revision|Accepted - CEP remains valid|26/08/2022; Monograph revision|CEP granted|23/04/2021 |
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| 664 | Dopamine hydrochloride | WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi City CN | 100022200;100030902 | CEP 2023-178 - Rev 00 | 2025/09/25 | Valid | 25/09/2030 | Chemical | 2025/09/25 | New application|CEP granted|25/09/2025 | |
| 1699 | Mesalazine, Mesalazine (MZ4B Process) | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2020-381 - Rev 01 | 2025/09/25 | Valid | Chemical | 2025/11/26 | Renewal|Accepted - CEP remains valid|26/11/2025; Major revision|CEP granted|25/09/2025; Minor revision|Accepted - CEP remains valid|19/09/2024; Notification|Accepted - CEP remains valid|26/06/2023; New application|CEP granted|15/03/2021 |
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| 3132 | Mirabegron, Alpha form | PIRAMAL PHARMA LIMITED Digwal Village IN | 100036948;100058375 | CEP 2024-093 - Rev 00 | 2025/09/25 | Valid | 25/09/2030 | Chemical | 2025/09/25 | New application|CEP granted|25/09/2025 | |
| 651 | Amiloride hydrochloride dihydrate | BAL PHARMA LIMITED Bengaluru IN | 100016398;100041736 | CEP 2022-337 - Rev 00 | 2025/09/25 | Valid | 25/09/2030 | Chemical | 2025/09/25 | New application|CEP granted|25/09/2025 | |
| 1451 | Mupirocin calcium, Process B | FUJIAN COMHONY BIOTECHNOLOGY CO., LTD. Fuqing CN | 100043888;100072481 | CEP 2022-501 - Rev 01 | 2025/09/25 | Valid | 28/03/2029 | Chemical and TSE | 2025/09/25 | Minor revision|CEP granted|25/09/2025; New application|CEP granted|28/03/2024 |
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| 2307 | Modafinil | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2008-199 - Rev 05 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Notification|CEP granted|01/08/2024 |
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| 2617 | Aripiprazole | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2013-330 - Rev 03 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Notification|CEP granted|29/07/2024; Monograph revision|CEP granted|02/09/2021; Renewal|CEP granted|30/04/2020 |
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| 2338 | Mirtazapine | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2008-205 - Rev 07 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Notification|CEP granted|30/07/2024; Minor revision|CEP granted|06/04/2022 |
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| 2303 | Adrenaline | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2015-006 - Rev 02 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Notification|CEP granted|29/07/2024; Monograph revision|Accepted - CEP remains valid|30/01/2023; Renewal|CEP granted|30/11/2021 |
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| 599 | Cisplatin | QILU PHARMACEUTICAL CO., LTD. Jinan CN | 100014051;100061315 | CEP 2010-122 - Rev 03 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Minor revision|Accepted - CEP remains valid|06/06/2025; Minor revision|Accepted - CEP remains valid|16/06/2022; Notification|Accepted - CEP remains valid|28/01/2022; Notification|CEP granted|16/09/2021; Notification|Accepted - CEP remains valid|24/04/2020 |
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| 2119 | Venlafaxine hydrochloride | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy District IN | 100051463;100098142 | CEP 2006-236 - Rev 06 | 2025/09/24 | Valid | Chemical | 2025/09/24 | Notification|CEP granted|24/09/2025; Notification|CEP granted|31/07/2024 |
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