| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2930 | Valganciclovir hydrochloride | ZHEJIANG CHARIOTEER PHARMACEUTICAL CO., LTD Xianju CN | 100011826;100018693 | CEP 2023-414 - Rev 00 | 2025/05/02 | Valid | 02/05/2030 | Chemical | 2025/05/02 | New application|CEP granted|02/05/2025 | |
| 867 | Triamcinolone hexacetonide, Micronised, Sterile | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2024-511 - Rev 00 | 2025/05/02 | Valid | 02/05/2030 | Chemical | 2025/05/02 | New application|CEP granted|02/05/2025 | |
| 996 | Clindamycin phosphate | HUBEI YITAI PHARMACEUTICAL CO., LTD. Tianmen CN | 100039319;100061892 | CEP 2022-145 - Rev 01 | 2025/05/02 | Valid | 27/05/2029 | Chemical | 2025/05/02 | Major revision|CEP granted|02/05/2025; New application|CEP granted|27/05/2024 |
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| 1753 | Iopromide | ZHEJIANG STARRY PHARMACEUTICAL CO., LTD. Xianju CN | 100024862;100034051 | CEP 2022-232 - Rev 01 | 2025/05/02 | Valid | 16/07/2029 | Chemical | 2025/05/02 | Notification|CEP granted|02/05/2025; New application|CEP granted|16/07/2024 |
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| 79 | Digoxin, Micronised, non-micronised | DECCAN NUTRACEUTICALS PRIVATE LIMITED Pune IN | 100023453;100032590 | CEP 2010-298 - Rev 02 | 2025/04/30 | Valid | Chemical | 2025/04/30 | Minor revision|CEP granted|30/04/2025 | ||
| 2600 | Olmesartan medoxomil | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100069944 | CEP 2012-228 - Rev 02 | 2025/04/30 | Valid | Chemical | 2025/04/30 | Major revision|CEP granted|30/04/2025; Notification|CEP granted|13/12/2022; Notification|Accepted - CEP remains valid|10/09/2020; Renewal|CEP granted|20/07/2020 |
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| 1524 | Gliclazide | INDOCO REMEDIES LIMITED Mumbai IN | 100020134;100061295 | CEP 2010-202 - Rev 01 | 2025/04/30 | Valid | Chemical | 2025/06/24 | Minor revision|Accepted - CEP remains valid|24/06/2025; Minor revision|CEP granted|30/04/2025; Minor revision|Accepted - CEP remains valid|17/07/2023; Minor revision|Accepted - CEP remains valid|05/03/2021 |
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| 2257 | Norflurane | SRF LIMITED Village Dahej IN | 100047941;100079283 | CEP 2018-195 - Rev 01 | 2025/04/30 | Valid | Chemical | 2025/04/30 | Renewal|CEP granted|30/04/2025 | ||
| 1226 | Imipenem monohydrate, Sterile | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2008-325 - Rev 04 | 2025/04/30 | Valid | Chemical | 2025/04/30 | Major revision|CEP granted|30/04/2025; Minor revision|CEP granted|20/03/2024 |
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| 2270 | Sildenafil citrate, Unit-VII | SMS PHARMACEUTICALS LIMITED Hyderabad IN | 100011780;100061058 | CEP 2025-066 - Rev 00 | 2025/04/30 | Valid | 30/04/2030 | Chemical | 2025/04/30 | New application|CEP granted|30/04/2025 | |
| 1374 | Thyme oil, thymol type, Rectified | FREY + LAU GMBH Henstedt-Ulzburg DE | 100017333;100026131 | CEP 2019-132 - Rev 01 | 2025/04/30 | Valid | Herbal | 2025/04/30 | Renewal|CEP granted|30/04/2025; Notification|Accepted - CEP remains valid|13/08/2021 |
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| 2601 | Pioglitazone hydrochloride | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2019-342 - Rev 02 | 2025/04/30 | Valid | Chemical | 2026/01/30 | Renewal|Accepted - CEP remains valid|30/01/2026; Minor revision|CEP granted|30/04/2025; Notification|CEP granted|12/01/2024; Minor revision|Accepted - CEP remains valid|22/06/2021 |
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| 372 | Benzalkonium chloride | HUBEI GEDIAN HUMANWELL PHARMACEUTICAL EXCIPIENTS CO. LTD. Ezhou City CN | 100049221;100083387 | CEP 2024-096 - Rev 00 | 2025/04/30 | Valid | 30/04/2030 | Chemical | 2025/04/30 | New application|CEP granted|30/04/2025 | |
| 1012 | Famotidine | AZICO BIOPHORE INDIA PRIVATE LIMITED Hyderabad IN | 100033325;100061652 | CEP 2021-094 - Rev 02 | 2025/04/29 | Valid | 16/12/2027 | Chemical | 2025/04/29 | Minor revision|CEP granted|29/04/2025; Notification|CEP granted|26/05/2023; New application|CEP granted|16/12/2022 |
|
| 1094 | Cyproterone acetate, Micronised | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2018-270 - Rev 01 | 2025/04/29 | Valid | Chemical | 2025/04/29 | Renewal|CEP granted|29/04/2025 | ||
| 583 | Lincomycin hydrochloride, Alternative process | XINYU PHARMACEUTICAL CO., LTD. Suzhou City CN | 100020532;100056331 | CEP 2020-105 - Rev 02 | 2025/04/29 | Valid | Chemical | 2025/04/29 | Renewal|CEP granted|29/04/2025; Notification|CEP granted|28/02/2024; New application|CEP granted|10/07/2020 |
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| 2416 | Pramipexole dihydrochloride monohydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2010-328 - Rev 04 | 2025/04/29 | Valid | Chemical | 2025/04/29 | Notification|CEP granted|29/04/2025; Minor revision|CEP granted|17/02/2023; Minor revision|Accepted - CEP remains valid|11/08/2021 |
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| 2931 | Sorafenib tosilate | SHANDONG LONCOM PHARMACEUTICAL CO., LTD Dezhou CN | 100048642;100080616 | CEP 2023-464 - Rev 00 | 2025/04/29 | Valid | 29/04/2030 | Chemical | 2025/04/29 | New application|CEP granted|29/04/2025 | |
| 1472 | Sodium hyaluronate, GS-120, intrinsic viscosity: 1.7 m3/kg; from fermentation; for parenteral administration, including intra-ocular use | KIKKOMAN BIOCHEMIFA COMPANY Noda City JP | 100039417;100087689 | CEP 2023-034 - Rev 02 | 2025/04/29 | Valid | 21/06/2028 | Chemical | 2025/04/29 | Minor revision|CEP granted|29/04/2025; Minor revision|CEP granted|30/04/2024; New application|CEP granted|21/06/2023 |
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| 2577 | Oxcarbazepine, Process-II | DASAMI LAB PRIVATE LIMITED Nalgonda IN | 100033206;100051825 | CEP 2023-348 - Rev 00 | 2025/04/29 | Valid | 29/04/2030 | Chemical | 2025/04/29 | New application|CEP granted|29/04/2025 |
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