| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1449 | Mometasone furoate | SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN | 100049295;100083729 | CEP 2024-044 - Rev 00 | 2025/06/27 | Valid | 27/06/2030 | Chemical | 2025/06/27 | New application|CEP granted|27/06/2025 | |
| 471 | Calcitonin (salmon), Synthetic | PIRAMAL PHARMA LIMITED Navi Mumbai IN | 100036948;100075608 | CEP 2012-236 - Rev 02 | 2025/06/25 | Valid | Chemical | 2025/06/25 | Minor revision|CEP granted|25/06/2025; Notification|CEP granted|04/10/2022 |
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| 2573 | Candesartan cilexetil | JIANGXI SYNERGY PHARMACEUTICAL CO., LTD. Yichun CN | 100020812;100080065 | CEP 2013-007 - Rev 05 | 2025/06/25 | Valid | Chemical | 2025/06/25 | Minor revision|CEP granted|25/06/2025; Minor revision|CEP granted|28/08/2024; Notification|CEP granted|20/09/2023; Notification|CEP granted|21/03/2023; Minor revision|Accepted - CEP remains valid|01/09/2021; Minor revision|CEP granted|24/11/2020; Notification|Abandoned|09/10/2020 |
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| 2420 | Tiotropium bromide monohydrate, Micronised, non-micronised | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2012-285 - Rev 03 | 2025/06/25 | Valid | Chemical | 2025/06/25 | Notification|CEP granted|25/06/2025; Minor revision|CEP granted|16/01/2024; Notification|Rejected|14/09/2023; Notification|CEP granted|28/07/2022 |
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| 946 | Ranitidine hydrochloride, Crystalline powder grade and D.C. grade | ORCHEV PHARMA PRIVATE LIMITED Rajkot IN | 100020650;100029403 | CEP 2007-320 - Rev 04 | 2025/06/25 | Valid | Chemical | 2025/06/25 | Administrative procedure|CEP granted|25/06/2025 | ||
| 1280 | Zolpidem tartrate | CENTAUR PHARMACEUTICALS PRIVATE LIMITED Mumbai IN | 100018245;100028824 | CEP 2002-171 - Rev 07 | 2025/06/25 | Valid | Chemical | 2025/06/25 | Minor revision|CEP granted|25/06/2025; Notification|CEP granted|20/10/2023 |
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| 1058 | Vancomycin hydrochloride | XELLIA PHARMACEUTICALS LTD. Budapest X HU | 100012234;100020635 | CEP 1999-110 - Rev 11 | 2025/06/25 | Valid | Chemical | 2025/06/25 | Minor revision|CEP granted|25/06/2025; Minor revision|CEP granted|21/02/2023; Notification|Accepted - CEP remains valid|11/01/2021 |
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| 2582 | Donepezil hydrochloride, Monohydrate | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2019-311 - Rev 02 | 2025/06/25 | Valid | 19/10/2026 | Chemical | 2025/12/02 | Minor revision|Accepted - CEP remains valid|02/12/2025; Minor revision|CEP granted|25/06/2025; Minor revision|Accepted - CEP remains valid|12/12/2024; Monograph revision|Accepted - CEP remains valid|13/12/2023; Major revision|CEP granted|31/01/2024 |
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| 1338 | Lavender oil | SCHWABE EXTRACTA GMBH & CO. KG Karlsruhe DE | 100021578;100030272 | CEP 2015-363 - Rev 02 | 2025/06/25 | Valid | Herbal | 2025/06/25 | Minor revision|CEP granted|25/06/2025; Minor revision|CEP granted|05/06/2023; Notification|Accepted - CEP remains valid|17/02/2023; Renewal|CEP granted|13/09/2022; Major revision|CEP granted|24/11/2021 |
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| 1765 | Salmeterol xinafoate, Micronised | MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN | 100014822;100073679 | CEP 2020-070 - Rev 02 | 2025/06/25 | Valid | Chemical | 2025/06/25 | Renewal|CEP granted|25/06/2025; Minor revision|CEP granted|30/08/2021; New application|CEP granted|14/08/2020 |
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| 2219 | Lansoprazole, Unit IV | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2020-185 - Rev 01 | 2025/06/25 | Valid | Chemical | 2025/06/25 | Renewal|CEP granted|25/06/2025; New application|CEP granted|26/08/2020 |
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| 2609 | Triclabendazole for veterinary use | ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN | 100033528;100052489 | CEP 2015-109 - Rev 03 | 2025/06/25 | Valid | Chemical | 2025/06/25 | Minor revision|CEP granted|25/06/2025; Major revision|CEP granted|03/07/2023; Minor revision|CEP granted|08/07/2022; Renewal|CEP granted|18/03/2022 |
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| 2931 | Sorafenib tosilate | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2022-056 - Rev 01 | 2025/06/25 | Valid | 10/06/2029 | Chemical | 2025/06/25 | Monograph revision|CEP granted|25/06/2025; New application|CEP granted|10/06/2024 |
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| 576 | Allopurinol | HENAN DONGTAI PHARM CO., LTD. Anyang CN | 100023192;100052097 | CEP 2023-232 - Rev 00 | 2025/06/25 | Valid | 25/06/2030 | Chemical | 2025/06/25 | New application|CEP granted|25/06/2025 | |
| 1706 | Thiamazole | MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN | 100020971;100029680 | CEP 2022-029 - Rev 02 | 2025/06/25 | Valid | 28/09/2028 | Chemical | 2025/06/25 | Monograph revision|CEP granted|25/06/2025; Minor revision|CEP granted|14/05/2024; New application|CEP granted|28/09/2023 |
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| 635 | Primaquine diphosphate, PQ3 Process | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2022-258 - Rev 01 | 2025/06/25 | Valid | 23/06/2028 | Chemical | 2025/06/25 | Minor revision|CEP granted|25/06/2025; New application|CEP granted|23/06/2023 |
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| 1393 | Benzbromarone | ZHEJIANG CHEMSYN PHARM. CO., LTD. Quzhou CN | 100025798;100035044 | CEP 2023-109 - Rev 00 | 2025/06/25 | Valid | 25/06/2030 | Chemical | 2025/06/25 | New application|CEP granted|25/06/2025 | |
| 1790 | Naltrexone hydrochloride, Process 2 | SANECA PHARMACEUTICALS A.S. Hlohovec SK | 100002257;100000752 | CEP 2025-194 - Rev 00 | 2025/06/25 | Valid | 25/06/2030 | Chemical | 2025/06/25 | New application|CEP granted|25/06/2025 | |
| 2192 | Atovaquone, Form A, Process-II | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2025-001 - Rev 00 | 2025/06/25 | Valid | 25/06/2030 | Chemical | 2025/06/25 | New application|CEP granted|25/06/2025 | |
| 2735 | Gadobutrol monohydrate | MSN LIFE SCIENCES PRIVATE LIMITED Bhiknoor Village IN | 100018316;100070723 | CEP 2023-260 - Rev 00 | 2025/06/25 | Valid | 25/06/2030 | Chemical | 2025/06/25 | New application|CEP granted|25/06/2025 |
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