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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2637 | Pemetrexed disodium heptahydrate | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2014-235 - Rev 01 | 2023/09/07 | Valid | Chemical | 2023/09/07 | Monograph revision|CEP granted|07/09/2023; Major revision|Rejected|16/09/2022; Renewal|CEP granted|03/01/2022 |
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2768 | Fluticasone furoate | AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN | 100011968;100018590 | CEP 2022-238 - Rev 00 | 2023/09/07 | Valid | 07/09/2028 | Chemical | 2023/09/07 | New application|CEP granted|07/09/2023 | |
2932 | Rivaroxaban, Micronised | Moehs Iberica S.L. Rubi ES | 100029092;100068825 | CEP 2021-245 - Rev 01 | 2023/09/07 | Valid | 27/06/2028 | Chemical | 2023/09/07 | Minor revision|CEP granted|07/09/2023; New application|CEP granted|27/06/2023 |
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. | Collagen, Paste 04 | 3M DEUTSCHLAND GMBH Neuss DE | 100003197;100008658 | CEP 2003-152 - Rev 03 | 2023/09/07 | Valid | TSE | 2023/09/07 | Administrative procedure|CEP granted|07/09/2023; Notification|CEP granted|21/08/2023 |
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2359 | Dorzolamide hydrochloride, Process 2 | FDC Limited Mumbai IN | 100011646;100021030 | CEP 2023-236 - Rev 00 | 2023/09/07 | Valid | 07/09/2028 | Chemical | 2024/07/04 | Minor revision|Accepted - CEP remains valid|04/07/2024; New application|CEP granted|07/09/2023 |
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1322 | Fenofibrate | Moehs Iberica S.L. Rubi ES | 100029092;100068825 | CEP 1998-128 - Rev 08 | 2023/09/07 | Valid | Chemical | 2023/09/07 | Minor revision|CEP granted|07/09/2023; Minor revision|Accepted - CEP remains valid|03/08/2022; Minor revision|Accepted - CEP remains valid|04/06/2020 |
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2702 | Chlormadinone acetate, Micronised (grade 21), non-micronised | Farmabios SpA Gropello Cairoli IT | 100011643;100021232 | CEP 2018-122 - Rev 03 | 2023/09/07 | Valid | 25/11/2024 | Chemical | 2023/09/07 | Minor revision|CEP granted|07/09/2023; Minor revision|CEP granted|18/12/2020; Minor revision|CEP granted|13/05/2020 |
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2173 | Gabapentin | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100078783 | CEP 2011-154 - Rev 03 | 2023/09/07 | Valid | Chemical | 2023/09/07 | Administrative procedure|CEP granted|07/09/2023; Minor revision|CEP granted|30/08/2023 |
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553 | Ethambutol hydrochloride, Process-II | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2023-224 - Rev 00 | 2023/09/07 | Valid | 07/09/2028 | Chemical | 2023/09/07 | New application|CEP granted|07/09/2023 | |
729 | Naloxone hydrochloride dihydrate | NORAMCO, LLC. Wilmington US | 100048651;100080628 | CEP 2011-055 - Rev 03 | 2023/09/06 | Valid | Chemical | 2023/09/06 | Minor revision|CEP granted|06/09/2023; Notification|CEP granted|18/03/2022; Notification|CEP granted|05/03/2020 |
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1724 | Formoterol fumarate dihydrate, FRM | LUSOCHIMICA S.P.A. Lomagna IT | 100018957;100027729 | CEP 2011-262 - Rev 02 | 2023/09/05 | Valid | Chemical | 2023/09/06 | Minor revision|CEP granted|06/09/2023; Monograph revision|Accepted - CEP remains valid|29/04/2022 |
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2357 | Dydrogesterone | YANGZHOU AURISCO PHARMACEUTICAL CO., LTD. Yangzhou City CN | 100048379;100080110 | CEP 2021-460 - Rev 02 | 2023/09/05 | Valid | 07/11/2027 | Chemical | 2023/09/06 | Minor revision|CEP granted|06/09/2023; Minor revision|CEP granted|16/03/2023; New application|CEP granted|07/11/2022 |
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260 | Amoxicillin trihydrate, Enzymatic process | North China Pharmaceutical Group Semisyntech Co., Ltd. Shijiazhuang CN | 100023274;100032418 | CEP 2014-220 - Rev 02 | 2023/09/05 | Valid | Chemical | 2023/09/06 | Minor revision|CEP granted|06/09/2023; Minor revision|Accepted - CEP remains valid|09/05/2023; Minor revision|CEP granted|24/06/2022; Notification|Rejected|28/04/2022; Renewal|CEP granted|09/11/2020 |
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260 | Amoxicillin trihydrate, Enzymatic process, compacted | North China Pharmaceutical Group Semisyntech Co., Ltd. Shijiazhuang CN | 100023274;100032418 | CEP 2017-009 - Rev 01 | 2023/09/05 | Valid | Chemical | 2023/09/06 | Minor revision|CEP granted|06/09/2023; Minor revision|Accepted - CEP remains valid|06/10/2022; Renewal|CEP granted|02/03/2022 |
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394 | Hydrochlorothiazide | Changzhou Pharmaceutical Factory Jiangsu Province CN | 100012704;100018611 | CEP 2006-011 - Rev 04 | 2023/09/05 | Valid | Chemical | 2023/09/06 | Minor revision|CEP granted|06/09/2023; Minor revision|CEP granted|28/04/2023; Notification|CEP granted|08/11/2021 |
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68 | Atropine sulfate | ROLABO OUTSOURCING, S.L. Zaragoza ES | 100012139;100019601 | CEP 2015-002 - Rev 01 | 2023/09/04 | Valid | Chemical | 2023/09/04 | Minor revision|CEP granted|04/09/2023; Renewal|CEP granted|16/10/2020 |
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2056 | Atropine | ROLABO OUTSOURCING, S.L. Zaragoza ES | 100012139;100019601 | CEP 2015-255 - Rev 01 | 2023/09/04 | Valid | Chemical | 2023/09/04 | Minor revision|CEP granted|04/09/2023; Renewal|CEP granted|24/06/2021; Minor revision|Accepted - CEP remains valid|09/10/2020 |
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1724 | Formoterol fumarate dihydrate, Micronised | FERMION OY Espoo FI | 100011508;100020280 | CEP 2015-215 - Rev 02 | 2023/09/04 | Valid | Chemical | 2023/09/04 | Major revision|CEP granted|04/09/2023; Notification|CEP granted|07/11/2022; Notification|Rejected|28/06/2022; Monograph revision|Accepted - CEP remains valid|12/04/2022; Renewal|CEP granted|21/09/2021; Notification|Accepted - CEP remains valid|22/01/2020 |
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1651 | Clarithromycin, Process 2 | SM BIOMED SDN BHD Sungai Petani MY | 100018119;100026902 | CEP 2022-483 - Rev 00 | 2023/09/04 | Valid | 04/09/2028 | Chemical | 2023/09/04 | New application|CEP granted|04/09/2023 | |
2778 | Sitagliptin phosphate monohydrate | JUBILANT PHARMOVA LIMITED Nanjangud IN | R0-CEP 2021-175 - Rev 00 | 2023/08/31 | Valid | 31/08/2028 | Chemical | 2023/09/01 | New application|CEP granted|01/09/2023 |