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 |
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2570 | Desloratadine | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2014-321 - Rev 02 | 2024/01/25 | Valid | Chemical | 2024/01/25 | Minor revision|CEP granted|25/01/2024; Minor revision|CEP granted|05/04/2023; Renewal|CEP granted|11/02/2021; Minor revision|CEP granted|25/06/2020 |
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1121 | Lorazepam | R L FINE CHEM PVT. LTD. Gowribidanur IN | 100016723;100053383 | CEP 2010-217 - Rev 03 | 2024/01/25 | Valid | Chemical | 2024/09/19 | Minor revision|Accepted - CEP remains valid|19/09/2024; Minor revision|CEP granted|25/01/2024; Minor revision|CEP granted|01/06/2022 |
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942 | Omeprazole | ZHEJIANG HUAYI PHARMACEUTICAL CO., LTD. Yiwu CN | 100012165;100019516 | CEP 2012-326 - Rev 01 | 2024/01/25 | Valid | Chemical | 2024/01/25 | Minor revision|CEP granted|25/01/2024; Notification|Accepted - CEP remains valid|01/02/2022 |
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2254 | Moxifloxacin hydrochloride, Monohydrate | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2015-269 - Rev 02 | 2024/01/25 | Valid | Chemical | 2024/01/25 | Notification|CEP granted|25/01/2024; Minor revision|Abandoned|22/01/2024; Minor revision|CEP granted|20/06/2023; Renewal|CEP granted|27/07/2022; Minor revision|CEP granted|29/03/2021; Minor revision|Accepted - CEP remains valid|23/06/2020 |
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2888 | Rupatadine fumarate | CADILA PHARMACEUTICALS LIMITED Ankleshwar IN | 100003616;100000498 | CEP 2018-161 - Rev 02 | 2024/01/25 | Valid | 02/06/2025 | Chemical | 2024/01/25 | Minor revision|CEP granted|25/01/2024; Minor revision|Accepted - CEP remains valid|01/08/2022; Minor revision|CEP granted|18/12/2020 |
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245 | Pyridoxine hydrochloride, Grenzach II | DSM Nutritional Products Ltd. Kaiseraugst CH | 100012007;100022521 | CEP 2022-492 - Rev 01 | 2024/01/25 | Valid | 20/12/2028 | Chemical | 2024/01/25 | Administrative procedure|CEP granted|25/01/2024; New application|CEP granted|20/12/2023 |
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2593 | Docetaxel | WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN | 100049301;100083738 | CEP 2022-011 - Rev 00 | 2024/01/25 | Valid | 25/01/2029 | Chemical | 2024/01/25 | New application|CEP granted|25/01/2024 | |
1970 | Atracurium besilate, Manufacturing code: 55 | CF PHARMA LTD. Budapest HU | 100022980;100031712 | CEP 2020-436 - Rev 02 | 2024/01/25 | Valid | 08/01/2026 | Chemical | 2024/01/25 | Minor revision|CEP granted|25/01/2024; Minor revision|Accepted - CEP remains valid|01/02/2022; Minor revision|Accepted - CEP remains valid|18/11/2021; Administrative procedure|CEP granted|11/02/2021; New application|CEP granted|08/01/2021 |
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522 | Pholcodine monohydrate | ALKALOIDA CHEMICAL COMPANY ZRT. Tiszavasvari HU | 100001084;100002269 | CEP 2016-268 - Rev 01 | 2024/01/25 | Valid | Chemical | 2024/01/25 | Renewal|CEP granted|25/01/2024; Minor revision|Accepted - CEP remains valid|26/05/2021 |
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3059 | Melatonin | FLAMMA S.P.A. Chignolo d'Isola IT | 100012051;100020885 | CEP 2023-171 - Rev 00 | 2024/01/24 | Valid | 24/01/2029 | Chemical | 2024/01/24 | New application|CEP granted|24/01/2024 | |
2373 | Meloxicam, Powder and milled grade | ESTEVE QUIMICA S.A. Barcelona ES | 100002266;100056508 | CEP 2011-037 - Rev 02 | 2024/01/24 | Valid | Chemical | 2024/01/24 | Notification|CEP granted|24/01/2024; Notification|CEP granted|28/10/2020 |
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578 | Ampicillin sodium, Sterile and bacterial endotoxins free | ACS DOBFAR S.P.A. Tribiano IT | 100011589;100019524 | CEP 2004-303 - Rev 03 | 2024/01/24 | Valid | Chemical | 2024/01/24 | Minor revision|CEP granted|24/01/2024; Major revision|CEP granted|04/12/2020 |
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1898 | Valerian dry hydroalcoholic extract, DER: 2.5-3.3:1 | GREENTECH Saint-Beauzire FR | 100020293;100029057 | CEP 2011-229 - Rev 01 | 2024/01/24 | Suspended by Holder | 2024/07/25 | Herbal | 2024/01/24 | Transfer of holdership|CEP granted|24/01/2024 | |
330 | Gelatin, Limed bone gelatin | TESSENDERLO GROUP N.V. Vilvoorde BE | 100038809;100060926 | CEP 2000-045 - Rev 06 | 2024/01/24 | Valid | TSE | 2024/01/24 | Administrative procedure|CEP granted|24/01/2024; Major revision|CEP granted|03/01/2024 |
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2114 | Lysine acetate | EVONIK REXIM S.A.S. Ham FR | 100012329;100020964 | CEP 2010-155 - Rev 03 | 2024/01/24 | Valid | Chemical | 2024/01/24 | Monograph revision|CEP granted|24/01/2024; Notification|CEP granted|14/03/2022 |
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2594 | Duloxetine hydrochloride | ZHEJIANG HUAYI PHARMACEUTICAL CO., LTD. Yiwu CN | 100012165;100019516 | CEP 2015-155 - Rev 01 | 2024/01/24 | Valid | Chemical | 2024/01/24 | Minor revision|CEP granted|24/01/2024; Renewal|CEP granted|24/02/2022 |
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1280 | Zolpidem tartrate, Site-II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2020-320 - Rev 02 | 2024/01/24 | Valid | 13/01/2026 | Chemical | 2024/01/24 | Notification|CEP granted|24/01/2024; Minor revision|CEP granted|22/09/2022; New application|CEP granted|13/01/2021 |
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1882 | Passionflower herb dry extract, DER: 2-5:1 | GREENTECH Saint-Beauzire FR | 100020293;100029057 | CEP 2011-230 - Rev 01 | 2024/01/24 | Suspended by Holder | 2024/07/25 | Herbal | 2024/01/24 | Transfer of holdership|CEP granted|24/01/2024 | |
1245 | Nimodipine | LUSOCHIMICA S.P.A. Lomagna IT | 100018957;100027729 | CEP 2022-403 - Rev 00 | 2024/01/24 | Valid | 24/01/2029 | Chemical | 2024/01/24 | New application|CEP granted|24/01/2024 | |
394 | Hydrochlorothiazide | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2021-088 - Rev 00 | 2024/01/23 | Valid | 23/01/2029 | Chemical | 2024/01/23 | New application|CEP granted|23/01/2024 |