| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2306 | Gemcitabine hydrochloride | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | R1-CEP 2006-222 - Rev 01 | 2023/02/23 | Valid | Chemical | 2023/02/23 | Minor revision|CEP granted|23/02/2023 | ||
| 1088 | Cinchocaine Hydrochloride, Micronised and non-micronised | PHARMASYNTHESE Saint Pierre Les Elbeuf FR | 100012546;100020952 | R1-CEP 2007-117 - Rev 02 | 2023/02/23 | Valid | Chemical | 2023/02/23 | Minor revision|CEP granted|23/02/2023 | ||
| 2232 | Losartan potassium | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | R1-CEP 2013-166 - Rev 05 | 2023/02/23 | Valid | Chemical | 2023/02/23 | Minor revision|CEP granted|23/02/2023; Notification|CEP granted|02/02/2023; Minor revision|CEP granted|22/08/2022; Major revision|CEP granted|06/04/2022; Major revision|CEP granted|08/12/2020 |
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| 2932 | Rivaroxaban, Micronised | BAYER AG Leverkusen DE | 100000011;100001505 | R0-CEP 2021-090 - Rev 00 | 2023/02/22 | Valid | 22/02/2028 | Chemical | 2023/05/11 | Minor revision|Accepted - CEP remains valid|11/05/2023; New application|CEP granted|22/02/2023 |
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| 2600 | Olmesartan medoxomil, Process – II | AMOLI ORGANICS PRIVATE LIMITED Mumbai IN | 100016500;100025303 | R0-CEP 2021-404 - Rev 01 | 2023/02/22 | Valid | 20/04/2027 | Chemical | 2023/02/22 | Minor revision|CEP granted|22/02/2023; Notification|Rejected|27/01/2023; New application|CEP granted|20/04/2022 |
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| . | Foetal Bovine Serum, Product code SH 30084 | CYTIVA Tauranga NZ | R1-CEP 2000-384 - Rev 05 | 2023/02/22 | Valid | TSE | 2023/02/22 | Major revision|CEP granted|22/02/2023; Notification|Accepted - CEP remains valid|05/12/2022; Major revision|CEP granted|29/04/2022; Notification|Rejected|07/03/2022; Notification|Accepted - CEP remains valid|28/07/2021; Notification|Accepted - CEP remains valid|04/05/2021; Notification|CEP granted|05/06/2020 |
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| 2334 | Letrozole | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | R1-CEP 2012-145 - Rev 02 | 2023/02/22 | Valid | Chemical | 2023/02/22 | Minor revision|CEP granted|22/02/2023; Monograph revision|Accepted - CEP remains valid|27/01/2021 |
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| 2591 | Celecoxib | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | R1-CEP 2016-037 - Rev 01 | 2023/02/22 | Valid | Chemical | 2023/11/27 | Minor revision|Accepted - CEP remains valid|27/11/2023; Minor revision|CEP granted|22/02/2023; Renewal|CEP granted|17/08/2022; Minor revision|Accepted - CEP remains valid|29/04/2021; Minor revision|Accepted - CEP remains valid|17/08/2020 |
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| 2443 | Fulvestrant | Farmabios SpA Gropello Cairoli IT | 100011643;100021232 | R1-CEP 2016-169 - Rev 00 | 2023/02/22 | Valid | Chemical | 2023/02/22 | Renewal|CEP granted|22/02/2023; Major revision|CEP granted|03/08/2022 |
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| 2235 | Methylphenidate hydrochloride | VERANOVA, L.P. West Deptford US | 100012273;100018937 | R1-CEP 2017-119 - Rev 00 | 2023/02/22 | Valid | Chemical | 2023/04/25 | Minor revision|Accepted - CEP remains valid|25/04/2023; Renewal|CEP granted|22/02/2023; Minor revision|Accepted - CEP remains valid|08/06/2022 |
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| 2372 | Esomeprazole magnesium trihydrate | MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN | 100018316;100027671 | R0-CEP 2019-253 - Rev 01 | 2023/02/21 | Valid | 11/08/2026 | Chemical | 2023/02/21 | Minor revision|CEP granted|21/02/2023 | |
| 2631 | Rosuvastatin calcium, Process III | GLENMARK LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | R0-CEP 2022-377 - Rev 00 | 2023/02/21 | Valid | 21/02/2028 | Chemical | 2023/02/21 | New application|CEP granted|21/02/2023 | |
| 1058 | Vancomycin hydrochloride | XELLIA PHARMACEUTICALS LTD Budapest HU | 100012234;100020635 | R1-CEP 1999-110 - Rev 10 | 2023/02/21 | Valid | Chemical | 2023/02/21 | Minor revision|CEP granted|21/02/2023; Notification|Accepted - CEP remains valid|11/01/2021 |
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| 2258 | Olanzapine | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100053537 | R1-CEP 2012-050 - Rev 02 | 2023/02/21 | Valid | Chemical | 2023/02/21 | Minor revision|CEP granted|21/02/2023 | ||
| 1250 | Omega-3-acid ethyl esters 90, With mixed tocopherol | SHANDONG TENMORE TRADING CO., LTD. Linyi City CN | R1-CEP 2016-033 - Rev 00 | 2023/02/21 | Valid | Chemical | 2023/02/21 | Renewal|CEP granted|21/02/2023 | |||
| 2107 | Vinorelbine tartrate | JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD. Lianyungang City CN | R1-CEP 2017-075 - Rev 00 | 2023/02/21 | Valid | Chemical | 2023/05/15 | Minor revision|Accepted - CEP remains valid|15/05/2023; Renewal|CEP granted|21/02/2023; Minor revision|Accepted - CEP remains valid|07/06/2022 |
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| 573 | Verapamil hydrochloride | ASSURGEN PHARMA PVT LTD Lalamkoduru Village IN | 100048048;100079469 | R0-CEP 2019-014 - Rev 01 | 2023/02/20 | Valid | 12/04/2026 | Chemical | 2023/02/20 | Minor revision|CEP granted|20/02/2023 | |
| 2531 | Clopidogrel hydrogen sulfate, Form II | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100000217 | R0-CEP 2021-052 - Rev 01 | 2023/02/20 | Valid | 17/08/2027 | Chemical | 2023/09/14 | Minor revision|Accepted - CEP remains valid|14/09/2023; Minor revision|Accepted - CEP remains valid|12/05/2023; Minor revision|CEP granted|20/02/2023; New application|CEP granted|17/08/2022 |
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| 1075 | Budesonide | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | 100016183;100024971 | R0-CEP 2021-346 - Rev 00 | 2023/02/20 | Valid | 20/02/2028 | Chemical | 2023/02/20 | New application|CEP granted|20/02/2023 | |
| 2771 | Ibandronate sodium monohydrate | PHARMACEUTICAL WORKS POLPHARMA S.A. Starogard Gdanski PL | 100000470;100001572 | R0-CEP 2022-073 - Rev 00 | 2023/02/20 | Valid | 20/02/2028 | Chemical | 2023/02/20 | New application|CEP granted|20/02/2023 |
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