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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223 | Ergometrine Maleate | TAPI CZECH INDUSTRIES S.R.O. Opava CZ | 100051642;100090678 | CEP 2012-387 - Rev 03 | 2024/12/23 | Valid | Chemical | 2024/12/23 | Minor revision|CEP granted|23/12/2024; Minor revision|CEP granted|09/12/2022; Notification|Accepted - CEP remains valid|24/03/2021; Monograph revision|CEP granted|21/04/2020 |
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1008 | Domperidone maleate, Process II | SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN | 100015104;100023787 | CEP 2020-096 - Rev 01 | 2024/12/23 | Valid | 17/07/2028 | Chemical | 2024/12/23 | Notification|CEP granted|23/12/2024; New application|CEP granted|17/07/2023 |
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1665 | Betahistine dihydrochloride | Laboratorios Espinos Y Bofill S.A. Cornella de Llobregat ES | 100021595;100030302 | CEP 2009-177 - Rev 03 | 2024/12/23 | Valid | Chemical | 2024/12/23 | Minor revision|CEP granted|23/12/2024 | ||
2992 | Lacosamide, Form-I | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2018-099 - Rev 03 | 2024/12/23 | Valid | Chemical | 2024/12/23 | Renewal|CEP granted|23/12/2024; Minor revision|Accepted - CEP remains valid|09/09/2022; Major revision|CEP granted|03/11/2021; Minor revision|Rejected|02/07/2021; Minor revision|CEP granted|31/08/2020 |
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2019 | Perindopril tert-butylamine, PER55LP | APOTEX PHARMACHEM INDIA PVT. LTD Bangalore IN | 100012611;100041734 | CEP 2019-196 - Rev 02 | 2024/12/23 | Valid | Chemical | 2024/12/23 | Renewal|CEP granted|23/12/2024; Minor revision|CEP granted|21/08/2023 |
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2258 | Olanzapine, Form II Micronised | TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL | 100000702;100060842 | CEP 2024-297 - Rev 00 | 2024/12/23 | Valid | 23/12/2029 | Chemical | 2024/12/23 | New application|CEP granted|23/12/2024 | |
914 | Hydroxocobalamin chloride | Hebei Huarong Pharmaceutical Co Ltd Xingtai CN | 100020003;100061302 | CEP 2023-256 - Rev 00 | 2024/12/23 | Valid | 23/12/2029 | Chemical | 2024/12/23 | New application|CEP granted|23/12/2024 | |
931 | Metformin Hydrochloride, 2nd line | NINGXIA HENGKANG TECHNOLOGY CO., LTD. Yinchuan CN | 100049743;100086705 | CEP 2024-237 - Rev 01 | 2024/12/23 | Valid | 02/08/2029 | Chemical | 2024/12/23 | Minor revision|CEP granted|23/12/2024; New application|CEP granted|02/08/2024 |
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2932 | Rivaroxaban | MEHTA API PVT. LTD. Boisar IN | 100020995;100042931 | CEP 2022-212 - Rev 01 | 2024/12/23 | Valid | 30/05/2029 | Chemical | 2024/12/23 | Minor revision|CEP granted|23/12/2024; New application|CEP granted|30/05/2024 |
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2932 | Rivaroxaban, Micronised | INDOCO REMEDIES LIMITED Mumbai IN | 100020134;100061295 | CEP 2022-159 - Rev 01 | 2024/12/23 | Valid | 26/06/2028 | Chemical | 2024/12/23 | Minor revision|CEP granted|23/12/2024; New application|CEP granted|26/06/2023 |
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809 | Betamethasone dipropionate | SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. Butterworth MY | 100014908;100053188 | CEP 2011-005 - Rev 02 | 2024/12/23 | Valid | Chemical | 2024/12/23 | Notification|CEP granted|23/12/2024 | ||
. | Foetal Bovine Serum | CAPRICORN SCIENTIFIC GMBH Ebsdorfergrund DE | 100051998;100091460 | CEP 2024-276 - Rev 00 | 2024/12/23 | Valid | 23/12/2029 | TSE | 2024/12/23 | New application|CEP granted|23/12/2024 | |
1354 | Oxybutynin hydrochloride, Process II | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2022-348 - Rev 01 | 2024/12/23 | Valid | 03/11/2027 | Chemical | 2024/12/23 | Minor revision|CEP granted|23/12/2024; New application|CEP granted|03/11/2022 |
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2235 | Methylphenidate hydrochloride | JANSSEN PHARMACEUTICA NV Beerse BE | 100000625;100005958 | CEP 2009-219 - Rev 04 | 2024/12/23 | Valid | Chemical | 2024/12/23 | Notification|CEP granted|23/12/2024; Notification|Accepted - CEP remains valid|18/01/2023; Notification|CEP granted|13/01/2022; Minor revision|CEP granted|15/12/2020 |
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1009 | Domperidone | SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN | 100015104;100023787 | CEP 1997-094 - Rev 10 | 2024/12/20 | Valid | Chemical | 2024/12/20 | Notification|CEP granted|20/12/2024; Monograph revision|Accepted - CEP remains valid|02/09/2022 |
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1973 | Cineole | DÜLLBERG KONZENTRA GMBH & CO. KG Hamburg DE | 100022402;100031085 | CEP 2023-198 - Rev 01 | 2024/12/20 | Valid | 13/11/2029 | Chemical | 2024/12/20 | Minor revision|CEP granted|20/12/2024; New application|CEP granted|13/11/2024 |
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1009 | Domperidone, Process II | SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN | 100015104;100023787 | CEP 2022-374 - Rev 01 | 2024/12/20 | Valid | 16/01/2028 | Chemical | 2024/12/20 | Notification|CEP granted|20/12/2024; New application|CEP granted|16/01/2023 |
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1008 | Domperidone maleate | SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN | 100015104;100023787 | CEP 2003-069 - Rev 06 | 2024/12/20 | Valid | Chemical | 2024/12/20 | Notification|CEP granted|20/12/2024; Monograph revision|CEP granted|10/10/2022; Minor revision|CEP granted|30/04/2020 |
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3095 | Dabigatran etexilate mesilate, Crystalline Form-I, micronised and non-micronised | MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN | 100018316;100027671 | CEP 2024-026 - Rev 00 | 2024/12/20 | Valid | 20/12/2029 | Chemical | 2024/12/20 | New application|CEP granted|20/12/2024 | |
2244 | Tacrolimus monohydrate | Chunghwa Chemical Synthesis & Biotech Co., Ltd. Shu-Lin TW | 100011999;100018609 | CEP 2018-241 - Rev 02 | 2024/12/20 | Valid | Chemical | 2024/12/20 | Renewal|CEP granted|20/12/2024; Minor revision|CEP granted|30/03/2023; Notification|Accepted - CEP remains valid|02/11/2020 |