| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 412 | Sodium citrate dihydrate | QUALITY CHEMICALS S.L. Esparreguera ES | 100025665;100034895 | CEP 2025-088 - Rev 00 | 2026/03/09 | Valid | 09/03/2031 | Chemical | 2026/03/09 | New application|CEP granted|09/03/2026 | |
| 1491 | Amlodipine besilate | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN | 100051463;100098142 | CEP 2006-119 - Rev 06 | 2026/03/09 | Valid | Chemical | 2026/03/09 | Administrative procedure|CEP granted|09/03/2026; Monograph revision|CEP granted|26/02/2026; Notification|CEP granted|12/07/2024 |
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| 369 | Azathioprine | APICHEM LABORATORIES PRIVATE LIMITED Yadadri Bhuvanagiri IN | 100049373;100087707 | CEP 2024-521 - Rev 00 | 2026/03/09 | Valid | 09/03/2031 | Chemical | 2026/03/09 | New application|CEP granted|09/03/2026 | |
| 3035 | Tapentadol hydrochloride | AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN | 100021822;100030527 | CEP 2021-290 - Rev 01 | 2026/03/09 | Valid | 24/11/2027 | Chemical | 2026/03/09 | Major revision|CEP granted|09/03/2026; Minor revision|Accepted - CEP remains valid|23/02/2023; New application|CEP granted|24/11/2022 |
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| 3139 | Brivaracetam, Process-II | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2025-533 - Rev 00 | 2026/03/09 | Valid | 09/03/2031 | Chemical | 2026/03/09 | New application|CEP granted|09/03/2026 | |
| 879 | Bromazepam | F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT | 100011866;100022277 | CEP 2004-034 - Rev 03 | 2026/03/09 | Valid | Chemical | 2026/03/09 | Minor revision|CEP granted|09/03/2026; Minor revision|Accepted - CEP remains valid|27/10/2022; Monograph revision|Accepted - CEP remains valid|30/06/2022; Minor revision|Accepted - CEP remains valid|03/06/2021 |
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| 2232 | Losartan potassium, Form I | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2009-247 - Rev 10 | 2026/03/09 | Valid | Chemical | 2026/03/09 | Minor revision|CEP granted|09/03/2026; Notification|CEP granted|02/12/2024; Notification|CEP granted|04/07/2023; Minor revision|CEP granted|05/01/2023; Minor revision|CEP granted|30/11/2021; Minor revision|CEP granted|01/07/2020 |
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| 2535 | Levetiracetam, Site 2 | ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN | 100049395;100084081 | CEP 2023-031 - Rev 01 | 2026/03/06 | Valid | 17/03/2028 | Chemical | 2026/03/06 | Minor revision|CEP granted|06/03/2026; New application|CEP granted|17/03/2023 |
|
| 1491 | Amlodipine besilate | SMRUTHI ORGANICS LIMITED Solapur IN | 100021370;100092013 | CEP 2023-393 - Rev 00 | 2026/03/06 | Valid | 06/03/2031 | Chemical | 2026/03/06 | New application|CEP granted|06/03/2026 | |
| 573 | Verapamil hydrochloride | PIRAMAL PHARMA LIMITED Digwal Village IN | 100036948;100058375 | CEP 2005-141 - Rev 07 | 2026/03/06 | Valid | Chemical | 2026/03/06 | Minor revision|CEP granted|06/03/2026; Minor revision|CEP granted|02/05/2022; Notification|CEP granted|20/11/2020 |
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| 1104 | Fluoxetine hydrochloride | CADILA PHARMACEUTICALS LIMITED Ankleshwar IN | 100003616;100000498 | CEP 2004-207 - Rev 08 | 2026/03/06 | Valid | Chemical | 2026/03/06 | Minor revision|CEP granted|06/03/2026; Minor revision|CEP granted|30/06/2025; Minor revision|CEP granted|07/03/2022; Monograph revision|CEP granted|01/04/2021 |
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| 2933 | Deferasirox | BAL PHARMA LIMITED Bengaluru IN | 100016398;100041736 | CEP 2024-364 - Rev 00 | 2026/03/06 | Valid | 06/03/2031 | Chemical | 2026/03/06 | New application|CEP granted|06/03/2026 | |
| 2336 | Capsicum oleoresin, refined and standardised, DER: 62-83:1 | ESPECIALIDADES FARMACEUTICAS CENTRUM S.A. Alicante ES | 100000287;100004304 | CEP 2024-163 - Rev 00 | 2026/03/05 | Valid | 05/03/2031 | Herbal | 2026/03/05 | New application|CEP granted|05/03/2026 | |
| 2119 | Venlafaxine hydrochloride, Process-C | HIKAL LIMITED Bengaluru IN | 100014769;100023445 | CEP 2020-400 - Rev 03 | 2026/03/05 | Valid | Chemical | 2026/03/05 | Renewal|CEP granted|05/03/2026; Minor revision|CEP granted|28/08/2024; Notification|CEP granted|07/09/2022; Minor revision|Accepted - CEP remains valid|29/03/2022; New application|CEP granted|11/03/2021 |
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| 1385 | Acitretin, Polymorph form-III, process-II | USV PRIVATE LIMITED Mumbai IN | 100006251;100010851 | CEP 2025-572 - Rev 00 | 2026/03/04 | Valid | 04/03/2031 | Chemical | 2026/03/04 | New application|CEP granted|04/03/2026 | |
| 2777 | Pregabalin, Process II, Milled, Form-I | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2022-028 - Rev 03 | 2026/03/04 | Valid | 04/07/2028 | Chemical | 2026/03/04 | Minor revision|CEP granted|04/03/2026; Minor revision|CEP granted|18/09/2025; Minor revision|CEP granted|23/09/2024; New application|CEP granted|04/07/2023 |
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| 1798 | Trospium chloride | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2010-040 - Rev 05 | 2026/03/04 | Valid | Chemical | 2026/03/04 | Minor revision|CEP granted|04/03/2026; Notification|CEP granted|11/04/2025; Minor revision|Accepted - CEP remains valid|30/06/2023; Notification|CEP granted|02/12/2022; Minor revision|Accepted - CEP remains valid|25/03/2021; Minor revision|Accepted - CEP remains valid|18/08/2020 |
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| 967 | Acetylcysteine | WUHAN GRAND HOYO CO., LTD. Wuhan CN | 100023371;100090500 | CEP 2022-064 - Rev 02 | 2026/03/04 | Valid | 23/05/2027 | Chemical | 2026/03/04 | Notification|CEP granted|04/03/2026; Minor revision|CEP granted|11/06/2024; Notification|Rejected|07/03/2024; New application|CEP granted|23/05/2022 |
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| 1673 | Isoflurane | SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN | 100025540;100034769 | CEP 2010-078 - Rev 02 | 2026/03/04 | Valid | Chemical | 2026/03/04 | Minor revision|CEP granted|04/03/2026; Minor revision|Accepted - CEP remains valid|24/03/2025; Notification|CEP granted|11/03/2025; Minor revision|Accepted - CEP remains valid|04/09/2020 |
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| 1765 | Salmeterol xinafoate, Micronised | MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN | 100014822;100073679 | CEP 2020-070 - Rev 03 | 2026/03/04 | Valid | Chemical | 2026/03/04 | Minor revision|CEP granted|04/03/2026; Renewal|CEP granted|25/06/2025; Minor revision|CEP granted|30/08/2021; New application|CEP granted|14/08/2020 |
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