| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |
| 2932 | Rivaroxaban | BAJAJ HEALTHCARE LIMITED Thane IN | 100021782;100061986 | CEP 2023-085 - 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 |
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| 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 | |
| 2930 | Valganciclovir hydrochloride, Crystalline Type II | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2023-217 - Rev 00 | 2025/04/29 | Valid | 29/04/2030 | Chemical | 2025/09/03 | Minor revision|Accepted - CEP remains valid|03/09/2025; New application|CEP granted|29/04/2025 |
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| 2733 | Escitalopram oxalate, Process-IV | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2025-005 - Rev 01 | 2025/04/29 | Valid | 05/03/2030 | Chemical | 2025/04/29 | Minor revision|CEP granted|29/04/2025; New application|CEP granted|05/03/2025 |
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| 2422 | Oseltamivir phosphate, Form-A, route code OV | MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN | 100018316;100027671 | CEP 2024-571 - Rev 00 | 2025/04/29 | Valid | 29/04/2030 | Chemical | 2025/04/29 | New application|CEP granted|29/04/2025 | |
| 2209 | Sulbactam sodium, Sterile | QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN | 100033695;100052910 | CEP 2024-030 - Rev 01 | 2025/04/29 | Valid | 14/03/2030 | Chemical | 2025/04/29 | Administrative procedure|CEP granted|29/04/2025; New application|CEP granted|14/03/2025 |
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| 645 | Tobramycin, Spray-dried, amorphous | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2024-023 - Rev 01 | 2025/04/29 | Valid | 25/06/2029 | Chemical | 2026/01/22 | Monograph revision|Accepted - CEP remains valid|22/01/2026; Notification|CEP granted|29/04/2025; New application|CEP granted|25/06/2024 |
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| 1489 | Ambroxol hydrochloride, Process II | AMI LIFESCIENCES PRIVATE LIMITED Karakhadi IN | 100021822;100030527 | CEP 2023-168 - Rev 01 | 2025/04/28 | Valid | 23/08/2028 | Chemical | 2025/04/28 | Minor revision|CEP granted|28/04/2025; New application|CEP granted|23/08/2023 |
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| 2127 | Clobetasol propionate | CURIA SPAIN S.A.U. Boecillo ES | 100011649;100019586 | CEP 2011-095 - Rev 02 | 2025/04/28 | Valid | Chemical | 2025/04/28 | Minor revision|CEP granted|28/04/2025; Notification|CEP granted|25/08/2021 |
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| 2133 | Troxerutin | TOPFOND PHARMACEUTICAL CO., LTD. Zhumadian CN | 100023369;100077278 | CEP 2023-419 - Rev 00 | 2025/04/28 | Valid | 28/04/2030 | Chemical | 2025/04/28 | New application|CEP granted|28/04/2025 | |
| 38 | Levodopa | SHANDONG LUKANG PHARMACEUTICAL CO., LTD. Jining City CN | 100025471;100071013 | CEP 2022-202 - Rev 00 | 2025/04/28 | Valid | 28/04/2030 | Chemical and TSE | 2025/04/28 | New application|CEP granted|28/04/2025 | |
| 2600 | Olmesartan medoxomil | CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN | 100038839;100060978 | CEP 2018-083 - Rev 04 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Renewal|CEP granted|25/04/2025; Minor revision|CEP granted|03/08/2023; Notification|Accepted - CEP remains valid|06/01/2023; Minor revision|Accepted - CEP remains valid|21/12/2022; Minor revision|CEP granted|06/09/2022; Monograph revision|CEP granted|06/05/2022 |
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| 2017 | Oxaliplatin, Process HER-2 | HERAEUS PRECIOUS METALS GMBH & CO. KG Hanau DE | 100012310;100021629 | CEP 2006-137 - Rev 06 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025; Notification|CEP granted|02/10/2023; Notification|CEP granted|18/07/2022; Notification|CEP granted|24/03/2021 |
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