| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1648 | Thioctic acid | SUZHOU FUSHILAI PHARMACEUTICAL CO., LTD. Changshu CN | 100033468;100052365 | CEP 2023-359 - Rev 00 | 2025/02/03 | Valid | 03/02/2030 | Chemical | 2025/02/03 | New application|CEP granted|03/02/2025 | |
| 2423 | Valsartan, ID: 7611 | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2011-121 - Rev 05 | 2025/01/31 | Valid | Chemical | 2025/01/31 | Minor revision|CEP granted|31/01/2025; Major revision|CEP granted|10/07/2024; Notification|CEP granted|04/02/2022; Minor revision|CEP granted|18/06/2021 |
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| 2536 | Milbemycin oxime for veterinary use | HUBEI HONCH PHARMACEUTICAL CO., LTD. Huanggang CN | 100036821;100058182 | CEP 2018-025 - Rev 04 | 2025/01/31 | Valid | Chemical | 2025/01/31 | Minor revision|CEP granted|31/01/2025; Minor revision|Accepted - CEP remains valid|03/12/2024; Renewal|CEP granted|14/02/2024; Minor revision|Accepted - CEP remains valid|18/05/2022; Minor revision|CEP granted|02/06/2020 |
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| 2825 | Tigecycline | SAG MANUFACTURING S.L.U. San Agustin de Guadalix ES | 100009832;100014254 | CEP 2023-015 - Rev 01 | 2025/01/31 | Valid | 26/11/2029 | Chemical | 2025/01/31 | Minor revision|CEP granted|31/01/2025; New application|CEP granted|26/11/2024 |
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| 1778 | Etidronate disodium | QUALIX DOT S.L. L’Hospitalet de Llobregat ES | 100042575;100087019 | CEP 2023-321 - Rev 00 | 2025/01/31 | Valid | 31/01/2030 | Chemical | 2025/01/31 | New application|CEP granted|31/01/2025 | |
| 922 | Ketoprofen | ANLON HEALTHCARE PVT. LTD. Pipaliya (Sadak) IN | 100049220;100083386 | CEP 2023-344 - Rev 00 | 2025/01/31 | Valid | 31/01/2030 | Chemical | 2025/01/31 | New application|CEP granted|31/01/2025 | |
| 2574 | Entacapone | HEC PHARM GMBH Berlin DE | 100002583;100009334 | CEP 2013-127 - Rev 03 | 2025/01/31 | Valid | Chemical | 2025/01/31 | Notification|CEP granted|31/01/2025; Notification|Accepted - CEP remains valid|12/03/2024; Minor revision|Accepted - CEP remains valid|02/01/2024; Minor revision|CEP granted|06/07/2022; Monograph revision|CEP granted|28/09/2020 |
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| 1742 | Esketamine hydrochloride | SUPRIYA LIFESCIENCE LIMITED Mumbai IN | 100015796;100024574 | CEP 2018-198 - Rev 01 | 2025/01/31 | Valid | 01/03/2026 | Chemical | 2025/01/31 | Minor revision|CEP granted|31/01/2025 | |
| 1030 | Minocycline hydrochloride dihydrate | ZHEJIANG MEDICINE CO., LTD. Shaoxing CN | 100022357;100084942 | CEP 2022-195 - Rev 00 | 2025/01/30 | Valid | 30/01/2030 | Chemical | 2025/01/30 | New application|CEP granted|30/01/2025 | |
| 2779 | Solifenacin succinate | Yuki Gosei Kogyo Co., Ltd. Tokyo JP | 100012281;100061902 | CEP 2023-361 - Rev 00 | 2025/01/30 | Valid | 30/01/2030 | Chemical | 2025/01/30 | New application|CEP granted|30/01/2025 | |
| 2577 | Oxcarbazepine | AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN | 100021822;100030527 | CEP 2022-108 - Rev 02 | 2025/01/30 | Valid | 28/06/2029 | Chemical | 2025/10/10 | Minor revision|Accepted - CEP remains valid|10/10/2025; Minor revision|CEP granted|30/01/2025; Major revision|CEP granted|03/10/2024; New application|CEP granted|28/06/2024 |
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| 260 | Amoxicillin trihydrate, Compacted | ZHUHAI UNITED LABORATORIES CO., LTD. Sanzao Town CN | 100022945;100052547 | CEP 2007-191 - Rev 04 | 2025/01/29 | Valid | Chemical | 2025/01/29 | Notification|CEP granted|29/01/2025; Notification|Accepted - CEP remains valid|13/06/2024; Minor revision|Accepted - CEP remains valid|15/10/2020 |
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| 1589 | Doxylamine hydrogen succinate | SIGMA-ALDRICH IRELAND LTD Arklow IE | 100019213;100027978 | CEP 2004-167 - Rev 02 | 2025/01/29 | Valid | Chemical | 2025/01/29 | Administrative procedure|CEP granted|29/01/2025; Minor revision|Accepted - CEP remains valid|24/01/2025; Notification|Accepted - CEP remains valid|22/07/2021 |
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| 2270 | Sildenafil citrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2013-002 - Rev 01 | 2025/01/29 | Valid | Chemical | 2025/01/29 | Minor revision|CEP granted|29/01/2025; Minor revision|Accepted - CEP remains valid|21/03/2024; Notification|Accepted - CEP remains valid|24/02/2023; Minor revision|Accepted - CEP remains valid|03/10/2022; Minor revision|Accepted - CEP remains valid|14/01/2022 |
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| 2637 | Pemetrexed disodium heptahydrate | SUZHOU LIXIN PHARMACEUTICAL CO., LTD. Suzhou CN | 100012102;100019568 | CEP 2020-398 - Rev 01 | 2025/01/29 | Valid | 03/01/2027 | Chemical | 2025/01/29 | Minor revision|CEP granted|29/01/2025; Monograph revision|Accepted - CEP remains valid|27/03/2023; New application|CEP granted|03/01/2022 |
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| 2191 | Atorvastatin calcium | CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN | 100038839;100060978 | CEP 2015-288 - Rev 01 | 2025/01/29 | Valid | Chemical | 2025/01/29 | Minor revision|CEP granted|29/01/2025; Minor revision|Accepted - CEP remains valid|13/06/2024; Renewal|CEP granted|05/06/2023; Major revision|CEP granted|18/11/2022; Notification|Rejected|09/08/2022; Monograph revision|Accepted - CEP remains valid|15/07/2022; Minor revision|Accepted - CEP remains valid|08/09/2021; Minor revision|CEP granted|08/07/2021 |
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| 252 | Zinc oxide | GRILLO ZINC POWDER GMBH Goslar DE | 100027314;100044134 | CEP 2018-254 - Rev 02 | 2025/01/29 | Valid | Chemical | 2025/01/29 | Renewal|CEP granted|29/01/2025; Notification|CEP granted|22/08/2024; Monograph revision|Accepted - CEP remains valid|04/04/2022 |
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| 2993 | Nilotinib hydrochloride monohydrate | SHANDONG LIXIN PHARMACEUTICAL CO. LTD. Zibo CN | 100048250;100079839 | CEP 2021-133 - Rev 01 | 2025/01/29 | Valid | 21/07/2028 | Chemical | 2025/01/29 | Minor revision|CEP granted|29/01/2025; New application|CEP granted|21/07/2023 |
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| 3046 | Pemetrexed disodium 2.5-hydrate | SUZHOU LIXIN PHARMACEUTICAL CO., LTD. Suzhou CN | 100012102;100019568 | CEP 2021-072 - Rev 01 | 2025/01/29 | Valid | 08/07/2027 | Chemical | 2025/01/29 | Minor revision|CEP granted|29/01/2025; New application|CEP granted|08/07/2022 |
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| 1751 | Fosinopril sodium, Rhodium process | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN | 100011833;100018698 | CEP 2024-433 - Rev 00 | 2025/01/29 | Valid | 29/01/2030 | Chemical | 2025/01/29 | New application|CEP granted|29/01/2025 |
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