| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 14 | Calcium carbonate, Sieved grade I (35) | OMYA SAS Omey FR | 100020502;100081592 | CEP 2001-366 - Rev 05 | 2025/11/21 | Valid | Chemical | 2025/11/21 | Minor revision|CEP granted|21/11/2025; Minor revision|CEP granted|25/05/2021; Minor revision|CEP granted|08/12/2020 |
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| 619 | Levomenthol | FREY + LAU GMBH Henstedt-Ulzburg DE | 100017333;100026131 | CEP 2019-058 - Rev 01 | 2025/11/21 | Valid | Chemical | 2025/11/21 | Renewal|CEP granted|21/11/2025; Renewal|Abandoned|04/07/2025; Notification|Accepted - CEP remains valid|13/08/2021; Notification|Accepted - CEP remains valid|25/02/2021 |
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| 2930 | Valganciclovir hydrochloride | SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO., LTD. Luoyang Town CN | 100020594;100034407 | CEP 2024-326 - Rev 00 | 2025/11/21 | Valid | 21/11/2030 | Chemical | 2025/11/21 | New application|CEP granted|21/11/2025 | |
| 260 | Amoxicillin trihydrate, Sterile | NORTH CHINA PHARMACEUTICAL GROUP SEMISYNTECH CO. LTD. Shijiazhuang CN | 100023274;100032418 | CEP 2024-583 - Rev 00 | 2025/11/21 | Valid | 21/11/2030 | Chemical | 2025/11/21 | New application|CEP granted|21/11/2025 | |
| 2017 | Oxaliplatin | SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan City CN | 100037406;100076812 | CEP 2013-113 - Rev 01 | 2025/11/21 | Valid | Chemical | 2025/11/21 | Minor revision|CEP granted|21/11/2025 | ||
| 1794 | Paclitaxel | WUXI TAXUS PHARMACEUTICAL CO. LTD. Wuxi City CN | 100052831;100093126 | CEP 2024-437 - Rev 00 | 2025/11/21 | Valid | 21/11/2030 | Chemical | 2025/11/21 | New application|CEP granted|21/11/2025 | |
| 1702 | Naproxen sodium | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2022-389 - Rev 01 | 2025/11/19 | Valid | 13/09/2029 | Chemical | 2025/11/19 | Minor revision|CEP granted|19/11/2025; New application|CEP granted|16/09/2024 |
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| 2756 | Amorolfine hydrochloride, Nantong site | SIEGFRIED AG Zofingen CH | 100011797;100022117 | CEP 2017-251 - Rev 01 | 2025/11/19 | Valid | Chemical | 2025/11/19 | Minor revision|CEP granted|19/11/2025; Minor revision|Accepted - CEP remains valid|22/08/2024; Renewal|CEP granted|11/01/2023 |
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| 781 | Phenoxyethanol | ICN POLFA RZESZOW S.A. Rzeszow PL | 100000280;100004301 | CEP 2023-276 - Rev 01 | 2025/11/19 | Valid | 06/05/2029 | Chemical | 2025/11/19 | Minor revision|CEP granted|19/11/2025; New application|CEP granted|06/05/2024 |
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| 67 | Folic acid hydrate | ZHEJIANG SHENGDA BIO-PHARM CO., LTD. Tiantai CN | 100024864;100041389 | CEP 2023-161 - Rev 01 | 2025/11/19 | Valid | 13/11/2029 | Chemical | 2025/11/19 | Notification|CEP granted|19/11/2025; New application|CEP granted|13/11/2024 |
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| 2341 | Cefpodoxime proxetil, Process 3 | QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN | 100033695;100052910 | CEP 2020-399 - Rev 02 | 2025/11/19 | Valid | Chemical | 2025/11/19 | Renewal|CEP granted|19/11/2025; Minor revision|CEP granted|03/01/2025; Notification|Accepted - CEP remains valid|17/11/2022; Minor revision|Accepted - CEP remains valid|18/01/2022; New application|CEP granted|15/03/2021 |
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| 3087 | Ticagrelor, Standard, micronised | ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL | 100000470;100001572 | CEP 2020-338 - Rev 04 | 2025/11/19 | Valid | 15/05/2028 | Chemical | 2025/11/19 | Notification|CEP granted|19/11/2025; Minor revision|CEP granted|27/10/2025; Minor revision|CEP granted|23/08/2024; Minor revision|CEP granted|17/01/2024; New application|CEP granted|15/05/2023 |
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| 2126 | Cefepime dihydrochloride monohydrate, Sterile | ACS DOBFAR S.P.A. Tribiano IT | 100011589;100019524 | CEP 2023-021 - Rev 01 | 2025/11/19 | Valid | 27/07/2028 | Chemical | 2025/11/19 | Major revision|CEP granted|19/11/2025; New application|CEP granted|27/07/2023 |
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| 1131 | Methylprednisolone hydrogen succinate | HENAN LIHUA PHARMACEUTICAL CO., LTD. Anyang CN | 100016183;100024971 | CEP 2024-159 - Rev 00 | 2025/11/17 | Valid | 17/11/2030 | Chemical | 2025/11/17 | New application|CEP granted|17/11/2025 | |
| 3095 | Dabigatran etexilate mesilate | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2023-382 - Rev 00 | 2025/11/17 | Valid | 17/11/2030 | Chemical | 2025/11/17 | New application|CEP granted|17/11/2025 | |
| 559 | Mannitol, For use in the manufacture of parenteral preparations | CARGILL S.R.L. Castelmassa IT | 100049176;100083235 | CEP 2005-019 - Rev 04 | 2025/11/17 | Valid | Chemical | 2025/11/17 | Minor revision|CEP granted|17/11/2025; Notification|CEP granted|24/06/2025 |
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| 2932 | Rivaroxaban | Changzhou Pharmaceutical Factory Changzhou CN | 100012704;100018611 | CEP 2021-252 - Rev 01 | 2025/11/17 | Valid | 12/09/2027 | Chemical | 2025/11/17 | Minor revision|CEP granted|17/11/2025; Notification|Accepted - CEP remains valid|20/12/2023; New application|CEP granted|12/09/2022 |
|
| 687 | Salbutamol sulfate, Micronised | VAMSI LABS LIMITED Solapur IN | 100014747;100096958 | CEP 2024-328 - Rev 00 | 2025/11/17 | Valid | 17/11/2030 | Chemical | 2025/11/17 | New application|CEP granted|17/11/2025 | |
| 524 | Promethazine hydrochloride | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100022690 | CEP 2024-304 - Rev 00 | 2025/11/17 | Valid | 17/11/2030 | Chemical | 2025/11/17 | New application|CEP granted|17/11/2025 | |
| 1336 | Ivermectin, Code iverm11 | ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN | 100011825;100018687 | CEP 2025-175 - Rev 01 | 2025/11/17 | Valid | 22/08/2030 | Chemical | 2025/11/17 | Minor revision|CEP granted|17/11/2025; New application|CEP granted|22/08/2025 |
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