| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 871 | Acebutolol hydrochloride | NURAY CHEMICALS PRIVATE LIMITED Thiruvallur IN | 100048890;100081754 | CEP 2024-109 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 2888 | Rupatadine fumarate | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2024-294 - Rev 01 | 2025/11/26 | Valid | 10/09/2030 | Chemical | 2025/11/26 | Minor revision|CEP granted|26/11/2025; New application|CEP granted|10/09/2025 |
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| 2992 | Lacosamide | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2024-405 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 2768 | Fluticasone furoate, Micronised | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2024-298 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 2097 | Mebeverine hydrochloride | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2024-278 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 2790 | Clopidogrel besilate | SYNTHIMED LABS PRIVATE LIMITED Derabassi IN | 100052287;100092080 | CEP 2024-347 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 2306 | Gemcitabine hydrochloride, Process-3 | LAURUS LABS LIMITED Hyderabad IN | 100011702;100032608 | CEP 2025-445 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 2765 | Eplerenone, Form-L Site-II | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2025-487 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 1394 | Bezafibrate | DEVI PHARMATECH PRIVATE LIMITED Visakhapatnam IN | 100053267;100094028 | CEP 2024-541 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 1804 | Hydroxypropylbetadex, Molar substitution (MS) 0.7 | ZIBO QIANHUI BIOLOGICAL TECHNOLOGY CO., LTD. Zibo City CN | 100046161;100076158 | CEP 2024-542 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 1486 | Adenosine | PHARMA WALDHOF GMBH Duesseldorf DE | 100035710;100056564 | CEP 2025-070 - Rev 00 | 2025/11/26 | Valid | 26/11/2030 | Chemical | 2025/11/26 | New application|CEP granted|26/11/2025 | |
| 1386 | Albendazole | SEQUENT SCIENTIFIC LIMITED Hyderabad IN | 100017805;100096208 | CEP 2005-010 - Rev 07 | 2025/11/24 | Valid | Chemical | 2025/11/24 | Minor revision|CEP granted|24/11/2025; Minor revision|CEP granted|20/03/2025; Minor revision|CEP granted|20/12/2024; Notification|Rejected|25/11/2024; Minor revision|CEP granted|24/07/2024; Minor revision|Accepted - CEP remains valid|29/09/2021; Minor revision|CEP granted|21/12/2020 |
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| 889 | Clomipramine Hydrochloride | BIOPHORE INDIA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN | 100028906;100063062 | CEP 2017-288 - Rev 02 | 2025/11/24 | Valid | Chemical | 2025/11/24 | Renewal|CEP granted|24/11/2025; Notification|CEP granted|15/05/2023 |
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| 1681 | Tramadol hydrochloride | VIRUPAKSHA ORGANICS LIMITED Hyderabad IN | 100021606;100076961 | CEP 2015-203 - Rev 03 | 2025/11/24 | Valid | Chemical | 2025/11/24 | Minor revision|CEP granted|24/11/2025; Minor revision|CEP granted|25/07/2023; Minor revision|CEP granted|27/03/2023; Renewal|CEP granted|23/09/2021 |
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| 2531 | Clopidogrel hydrogen sulfate | AARTI DRUGS LIMITED Mumbai IN | 100014953;100023652 | CEP 2019-104 - Rev 02 | 2025/11/24 | Valid | Chemical | 2025/11/24 | Renewal|CEP granted|24/11/2025; Minor revision|CEP granted|26/01/2023 |
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| 2762 | Capecitabine, Process II | INTAS PHARMACEUTICALS LIMITED Ahmedabad IN | 100011529;100023432 | CEP 2019-143 - Rev 02 | 2025/11/24 | Valid | Chemical | 2025/11/24 | Renewal|CEP granted|24/11/2025; Transfer of holdership|CEP granted|27/06/2022 |
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| 942 | Omeprazole | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2019-339 - Rev 01 | 2025/11/24 | Valid | Chemical | 2025/11/24 | Renewal|CEP granted|24/11/2025 | ||
| 780 | Oxytocin | PIRAMAL PHARMA LIMITED Navi Mumbai IN | 100036948;100075608 | CEP 2008-029 - Rev 05 | 2025/11/24 | Valid | Chemical | 2025/11/24 | Major revision|CEP granted|24/11/2025; Minor revision|Accepted - CEP remains valid|16/06/2025; Minor revision|Accepted - CEP remains valid|07/03/2024; Notification|Rejected|02/01/2024; Monograph revision|CEP granted|03/11/2023; Notification|CEP granted|04/10/2022; Notification|CEP granted|26/07/2022; Minor revision|CEP granted|13/09/2021 |
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| 1589 | Doxylamine hydrogen succinate | HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED Secunderabad IN | 100024077;100041595 | CEP 2024-195 - Rev 00 | 2025/11/24 | Valid | 24/11/2030 | Chemical | 2025/11/24 | New application|CEP granted|24/11/2025 | |
| 2773 | Memantine hydrochloride, Crystalline Form-I, Micronised and Non-micronised | MSN PHARMACHEM PRIVATE LIMITED Sangareddy District IN | 100014794;100023345 | CEP 2025-237 - Rev 00 | 2025/11/24 | Valid | 24/11/2030 | Chemical | 2025/11/24 | New application|CEP granted|24/11/2025 |
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