| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2131 | Tamsulosin hydrochloride, Ankleshwar site | ZENTIVA K.S. Prague CZ | 100004108;100002580 | CEP 2023-469 - Rev 00 | 2024/04/25 | Valid | 25/04/2029 | Chemical | 2024/04/25 | New application|CEP granted|25/04/2024 | |
| 2617 | Aripiprazole, Form B | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2017-289 - Rev 03 | 2024/04/25 | Valid | 26/02/2025 | Chemical | 2024/04/25 | Minor revision|CEP granted|25/04/2024; Notification|CEP granted|24/03/2023; Notification|CEP granted|08/09/2021; Monograph revision|Accepted - CEP remains valid|19/07/2021 |
|
| 2531 | Clopidogrel hydrogen sulfate, Process-IV/Form-I | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2023-377 - Rev 00 | 2024/04/25 | Valid | 25/04/2029 | Chemical | 2024/04/25 | New application|CEP granted|25/04/2024 | |
| 904 | Fluphenazine dihydrochloride | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2020-427 - Rev 01 | 2024/04/25 | Valid | 13/09/2027 | Chemical | 2024/04/25 | Minor revision|CEP granted|25/04/2024; New application|CEP granted|13/09/2022 |
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| 2775 | Nebivolol hydrochloride | JIANGSU WEIQIDA PHARMACEUTICAL CO., LTD. Nantong City CN | 100033628;100052716 | CEP 2022-069 - Rev 00 | 2024/04/25 | Valid | 25/04/2029 | Chemical | 2024/04/25 | New application|CEP granted|25/04/2024 | |
| 1159 | Tropicamide | Uquifa Mexico S.A. de C.V. Jiutepec MX | 100022026;100030736 | CEP 2016-330 - Rev 02 | 2024/04/25 | Valid | Chemical | 2024/04/25 | Renewal|CEP granted|25/04/2024; Minor revision|CEP granted|09/02/2021 |
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| 1065 | Alprazolam, Milled/micronised | UPJOHN US 2 LLC Morgantown US | 100051308;100089869 | CEP 2007-016 - Rev 02 | 2024/04/25 | Valid | Chemical | 2024/04/25 | Minor revision|CEP granted|25/04/2024; Notification|CEP granted|09/04/2020 |
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| 2212 | Sultamicillin tosilate dihydrate | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2008-168 - Rev 03 | 2024/04/25 | Valid | Chemical | 2024/04/25 | Minor revision|CEP granted|25/04/2024 | ||
| 97 | Morphine hydrochloride trihydrate | FRANCOPIA Paris FR | 100041331;100069306 | CEP 2008-208 - Rev 04 | 2024/04/25 | Valid | Chemical | 2024/04/25 | Monograph revision|CEP granted|25/04/2024; Notification|CEP granted|01/03/2024; Notification|Accepted - CEP remains valid|22/11/2023; Transfer of holdership|CEP granted|25/05/2022 |
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| 2930 | Valganciclovir hydrochloride, Site-II | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2024-111 - Rev 00 | 2024/04/24 | Valid | 24/04/2029 | Chemical | 2024/04/24 | New application|CEP granted|24/04/2024 | |
| 931 | Metformin Hydrochloride | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2021-311 - Rev 00 | 2024/04/24 | Valid | 24/04/2029 | Chemical | 2024/04/24 | New application|CEP granted|24/04/2024 | |
| 572 | Timolol maleate | FAREVA LA VALLEE Saint-Germain-Laprade FR | 100025243;100034451 | CEP 2021-304 - Rev 00 | 2024/04/24 | Valid | 24/04/2029 | Chemical | 2024/04/24 | New application|CEP granted|24/04/2024 | |
| 2375 | Raloxifene hydrochloride, Modified process | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-069 - Rev 00 | 2024/04/24 | Valid | 24/04/2029 | Chemical | 2024/04/24 | New application|CEP granted|24/04/2024 | |
| 2119 | Venlafaxine hydrochloride | ATUL BIOSCIENCE LIMITED Ambernath (East) IN | 100044514;100086818 | CEP 2022-447 - Rev 00 | 2024/04/24 | Valid | 24/04/2029 | Chemical | 2024/04/24 | New application|CEP granted|24/04/2024 | |
| 1404 | Cefoperazone sodium, Sterile | Qilu Antibiotics Pharmaceutical Co., Ltd. Jinan CN | 100033695;100052910 | CEP 2007-202 - Rev 04 | 2024/04/24 | Valid | Chemical | 2024/04/24 | Major revision|CEP granted|24/04/2024; Major revision|CEP granted|30/08/2022; Major revision|CEP granted|14/05/2020 |
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| 38 | Levodopa | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN | 100011833;100018698 | CEP 2017-090 - Rev 04 | 2024/04/24 | Valid | Chemical | 2024/04/24 | Renewal|CEP granted|24/04/2024; Minor revision|Accepted - CEP remains valid|28/08/2023; Minor revision|Accepted - CEP remains valid|28/10/2022; Minor revision|CEP granted|08/12/2021; Major revision|CEP granted|30/07/2020 |
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| 1633 | Azelastine hydrochloride | EVONIK OPERATIONS GMBH Essen DE | 100012437;100020094 | CEP 2009-333 - Rev 05 | 2024/04/24 | Valid | Chemical | 2024/04/24 | Minor revision|CEP granted|24/04/2024; Minor revision|CEP granted|13/01/2021; Minor revision|CEP granted|16/04/2020 |
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| 1300 | Cefuroxime axetil, Amorphous | NECTAR LIFESCIENCES LIMITED Tehsil Dera Bassi IN | 100019097;100029430 | CEP 2009-045 - Rev 03 | 2024/04/24 | Valid | Chemical | 2024/04/24 | Minor revision|CEP granted|24/04/2024 | ||
| 2359 | Dorzolamide hydrochloride | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2011-102 - Rev 07 | 2024/04/24 | Valid | Chemical | 2024/04/24 | Notification|CEP granted|24/04/2024; Minor revision|Accepted - CEP remains valid|13/12/2021; Minor revision|CEP granted|07/01/2021; Minor revision|CEP granted|02/10/2020 |
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| . | Bovine pericardial tissue | COLLAGEN SOLUTIONS (US) LLC Eden Prairie US | 100049714;100086563 | CEP 2018-135 - Rev 02 | 2024/04/23 | Valid | TSE | 2024/04/23 | Renewal|CEP granted|23/04/2024; Major revision|CEP granted|31/10/2023 |
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