| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 330 | Gelatin, Limed bone gelatin | INDIA GELATINE AND CHEMICALS LIMITED Mumbai IN | 100054255;100096353 | CEP 2003-261 - Rev 02 | 2025/08/08 | Valid | Chemical and TSE | 2025/08/08 | Major revision|CEP granted|08/08/2025 | ||
| 1280 | Zolpidem tartrate | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2005-067 - Rev 03 | 2025/08/08 | Valid | Chemical | 2025/08/08 | Minor revision|CEP granted|08/08/2025; Monograph revision|Accepted - CEP remains valid|02/07/2020 |
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| 394 | Hydrochlorothiazide | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2009-103 - Rev 06 | 2025/08/08 | Valid | Chemical | 2025/08/08 | Minor revision|CEP granted|08/08/2025; Minor revision|CEP granted|02/10/2023; Notification|Accepted - CEP remains valid|09/12/2022; Minor revision|CEP granted|28/09/2022; Minor revision|CEP granted|09/04/2020 |
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| 1614 | Estradiol valerate, Micronised fine, non-micronised | VALDEPHARM Val de Reuil FR | 100011898;100018788 | CEP 2010-224 - Rev 06 | 2025/08/08 | Valid | Chemical | 2025/08/08 | Minor revision|CEP granted|08/08/2025; Minor revision|CEP granted|20/06/2024; Major revision|CEP granted|12/05/2023; Minor revision|CEP granted|02/09/2021 |
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| 1020 | Ketamine hydrochloride | AREVIPHARMA GMBH Radebeul DE | 100011616;100022155 | CEP 2015-037 - Rev 02 | 2025/08/08 | Valid | Chemical | 2025/08/08 | Minor revision|CEP granted|08/08/2025; Minor revision|CEP granted|08/02/2023; Renewal|CEP granted|24/11/2021; Minor revision|CEP granted|09/10/2020 |
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| 1793 | Oxycodone hydrochloride | SPECGX LLC Webster Groves US | 100017269;100031662 | CEP 2021-375 - Rev 01 | 2025/08/08 | Valid | 14/02/2028 | Chemical | 2025/08/08 | Minor revision|CEP granted|08/08/2025; New application|CEP granted|14/02/2023 |
|
| 1633 | Azelastine hydrochloride | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2019-018 - Rev 03 | 2025/08/08 | Valid | Chemical | 2025/08/08 | Renewal|CEP granted|08/08/2025; Notification|CEP granted|11/07/2022; Minor revision|CEP granted|08/03/2022 |
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| 622 | Meclozine dihydrochloride | FLEMING LABORATORIES LIMITED Nawabpet Village IN | 100015641;100024384 | CEP 2017-031 - Rev 01 | 2025/08/08 | Valid | Chemical | 2025/08/08 | Renewal|CEP granted|08/08/2025 | ||
| 2932 | Rivaroxaban | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2021-238 - Rev 01 | 2025/08/08 | Valid | 12/04/2028 | Chemical | 2025/08/08 | Minor revision|CEP granted|08/08/2025; New application|CEP granted|12/04/2023 |
|
| 1759 | Orphenadrine citrate | R.L. FINE CHEM PRIVATE LIMITED Bengaluru IN | 100016723;100067511 | CEP 2022-094 - Rev 01 | 2025/08/08 | Valid | 21/05/2029 | Chemical | 2025/08/08 | Minor revision|CEP granted|08/08/2025; New application|CEP granted|21/05/2024 |
|
| 996 | Clindamycin phosphate | TOPFOND PHARMACEUTICAL CO., LTD. Zhumadian CN | 100023369;100077278 | CEP 2023-082 - Rev 00 | 2025/08/08 | Valid | 08/08/2030 | Chemical | 2025/08/08 | New application|CEP granted|08/08/2025 | |
| 2077 | Metacresol | MEDILUX LABORATORIES PRIVATE LIMITED Pithampur IN | 100023732;100032901 | CEP 2023-353 - Rev 01 | 2025/08/08 | Valid | 05/03/2030 | Chemical | 2025/08/08 | Minor revision|CEP granted|08/08/2025; Notification|Rejected|20/06/2025; New application|CEP granted|05/03/2025 |
|
| 547 | Cyanocobalamin | NINGXIA KINGVIT PHARMACEUTICAL CO., LTD. YinChuan CN | 100034223;100090724 | CEP 2014-172 - Rev 01 | 2025/08/07 | Valid | Chemical | 2025/08/07 | Minor revision|CEP granted|07/08/2025; Renewal|CEP granted|29/03/2022 |
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| 1346 | Metamizole sodium monohydrate | SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN | 100011788;100019607 | CEP 2001-356 - Rev 05 | 2025/08/07 | Valid | Chemical | 2025/08/07 | Minor revision|CEP granted|07/08/2025; Notification|Accepted - CEP remains valid|24/06/2024; Minor revision|Accepted - CEP remains valid|20/01/2023 |
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| 333 | Heparin sodium, For parenteral preparations | OPOCRIN SpA Formigine IT | 100008856;100018068 | CEP 2002-006 - Rev 10 | 2025/08/07 | Valid | Chemical | 2025/08/07 | Major revision|CEP granted|07/08/2025; Monograph revision|Accepted - CEP remains valid|09/01/2025; Major revision|CEP granted|12/01/2022 |
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| 2631 | Rosuvastatin calcium, Site 2 | ZHEJIANG JIANGBEI NANHAI PHARMACEUTICAL CO., LTD Linhai City CN | 100049395;100084081 | CEP 2023-066 - Rev 01 | 2025/08/07 | Valid | 28/04/2028 | Chemical | 2025/08/07 | Minor revision|CEP granted|07/08/2025; New application|CEP granted|28/04/2023 |
|
| 781 | Phenoxyethanol | A&C AMERICAN CHEMICALS LTD. Montreal CA | 100038756;100060854 | CEP 2016-213 - Rev 03 | 2025/08/06 | Valid | Chemical | 2025/08/06 | Minor revision|CEP granted|06/08/2025; Renewal|CEP granted|19/01/2024; Minor revision|CEP granted|20/01/2022 |
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| 2338 | Mirtazapine | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2008-243 - Rev 06 | 2025/08/06 | Valid | Chemical | 2025/08/06 | Minor revision|CEP granted|06/08/2025; Notification|CEP granted|19/12/2022; Minor revision|Accepted - CEP remains valid|20/09/2022; Minor revision|Accepted - CEP remains valid|09/12/2021; Major revision|CEP granted|08/09/2020 |
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| 1705 | Sertraline hydrochloride | WANBURY LIMITED Vashi, Navi Mumbai IN | 100021364;100030068 | CEP 2008-173 - Rev 07 | 2025/08/06 | Valid | Chemical | 2025/08/06 | Minor revision|CEP granted|06/08/2025; Minor revision|CEP granted|08/04/2022; Minor revision|Accepted - CEP remains valid|18/05/2021; Minor revision|CEP granted|07/09/2020 |
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| 2254 | Moxifloxacin hydrochloride, Process II | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2013-078 - Rev 02 | 2025/08/06 | Valid | Chemical | 2025/08/06 | Minor revision|CEP granted|06/08/2025; Major revision|CEP granted|21/08/2024; Minor revision|Abandoned|20/06/2024; Minor revision|Accepted - CEP remains valid|07/06/2023; Monograph revision|Accepted - CEP remains valid|22/01/2021 |
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