| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2306 | Gemcitabine hydrochloride | FARMHISPANIA S.A. Montmeló ES | 100011645;100022190 | CEP 2024-203 - Rev 00 | 2025/06/17 | Valid | 17/06/2030 | Chemical | 2025/06/17 | New application|CEP granted|17/06/2025 | |
| 388 | Dexamethasone | SHANDONG SIRUI PHARMACEUTICAL CO., LTD. Heze CN | 100049295;100083729 | CEP 2024-325 - Rev 00 | 2025/06/17 | Valid | 17/06/2030 | Chemical | 2025/06/17 | New application|CEP granted|17/06/2025 | |
| 330 | Gelatin, Alkaline pre-treated acid hide | GELPRIME INDÚSTRIA E COMÉRCIO DE PRODUTOS ALIMENTÍCIOS LTDA Ibiporã BR | 100053196;100093882 | CEP 2024-514 - Rev 00 | 2025/06/17 | Valid | 17/06/2030 | TSE | 2025/06/17 | New application|CEP granted|17/06/2025 | |
| 1585 | Acamprosate calcium | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2025-018 - Rev 00 | 2025/06/17 | Valid | 17/06/2030 | Chemical | 2025/06/17 | New application|CEP granted|17/06/2025 | |
| 330 | Gelatin, Acid hide | GELPRIME INDÚSTRIA E COMÉRCIO DE PRODUTOS ALIMENTÍCIOS LTDA Ibiporã BR | 100053196;100093882 | CEP 2024-515 - Rev 00 | 2025/06/17 | Valid | 17/06/2030 | TSE | 2025/06/17 | New application|CEP granted|17/06/2025 | |
| 2191 | Atorvastatin calcium, JA | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2022-099 - Rev 02 | 2025/06/16 | Valid | 16/08/2027 | Chemical | 2025/06/16 | Minor revision|CEP granted|16/06/2025; Notification|Accepted - CEP remains valid|19/06/2024; Minor revision|CEP granted|15/03/2024; New application|CEP granted|16/08/2022 |
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| 47 | Nicotinamide | LONZA GUANGZHOU PHARMACEUTICAL LTD Guangzhou CN | 100024633;100096813 | CEP 2004-110 - Rev 07 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Notification|CEP granted|13/06/2025; Administrative procedure|CEP granted|28/09/2023; Notification|Accepted - CEP remains valid|16/08/2023; Notification|CEP granted|05/05/2021 |
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| 942 | Omeprazole | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 1997-122 - Rev 06 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025 | ||
| . | Collagen | TIGER AESTHETICS MEDICAL LLC Conshohocken US | 100054541;100096658 | CEP 2010-223 - Rev 01 | 2025/06/13 | Valid | TSE | 2025/06/13 | Notification|CEP granted|13/06/2025 | ||
| 1741 | Trimetazidine dihydrochloride | SHARON BIO-MEDICINE LIMITED Navi Mumbai IN | 100017869;100077413 | CEP 2010-075 - Rev 02 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025 | ||
| 14 | Calcium carbonate | SCORA Caffiers FR | 100017757;100026517 | CEP 1997-065 - Rev 05 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025 | ||
| 2049 | Econazole | PMC ISOCHEM Vert Le Petit FR | 100011861;100020972 | CEP 2020-047 - Rev 01 | 2025/06/13 | Valid | Chemical | 2025/10/23 | Renewal|Accepted - CEP remains valid|23/10/2025; Minor revision|CEP granted|13/06/2025; New application|CEP granted|18/09/2020 |
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| 1653 | Potassium clavulanate, diluted, with cellulose microcrystalline (0316) in ratio 1:1 | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN | 100033465;100082197 | CEP 2014-327 - Rev 01 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025; Renewal|CEP granted|05/03/2021 |
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| 1794 | Paclitaxel, Produced by a semi-synthetic process | FUJIAN SOUTH PHARMACEUTICAL CO., LTD. Sanming CN | 100012371;100021536 | CEP 2019-110 - Rev 03 | 2025/06/13 | Valid | Chemical | 2025/10/17 | Notification|Accepted - CEP remains valid|17/10/2025; Renewal|CEP granted|13/06/2025; Notification|CEP granted|16/06/2022; Minor revision|Accepted - CEP remains valid|01/04/2022; Minor revision|CEP granted|08/04/2021 |
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| 2280 | Fexofenadine hydrochloride | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2012-278 - Rev 04 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Notification|CEP granted|13/06/2025; Minor revision|CEP granted|12/03/2024; Major revision|CEP granted|12/12/2022; Major revision|CEP granted|23/03/2021; Renewal|CEP granted|29/07/2020 |
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| 2591 | Celecoxib | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2016-037 - Rev 02 | 2025/06/13 | Valid | Chemical | 2025/09/18 | Minor revision|Rejected|18/09/2025; Notification|CEP granted|13/06/2025; Minor revision|Accepted - CEP remains valid|27/11/2023; Minor revision|CEP granted|22/02/2023; Renewal|CEP granted|17/08/2022; Minor revision|Accepted - CEP remains valid|29/04/2021; Minor revision|Accepted - CEP remains valid|17/08/2020 |
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| 1002 | Diclofenac sodium | SHANGHAI JINDI JIUZHOU PHARMACEUTICAL (ANYANG) CO., LTD. Anyang CN | 100033462;100052355 | CEP 2023-204 - Rev 00 | 2025/06/13 | Valid | 13/06/2030 | Chemical | 2025/06/13 | New application|CEP granted|13/06/2025 | |
| 2465 | Irbesartan, Form-A | CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN | 100048075;100079517 | CEP 2023-237 - Rev 01 | 2025/06/13 | Valid | 12/06/2029 | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025; New application|CEP granted|12/06/2024 |
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| 395 | Hydrogen peroxide solution (3 per cent) | ARKEMA FRANCE Puteaux FR | 100049819;100096345 | CEP 2022-162 - Rev 02 | 2025/06/13 | Valid | 20/12/2028 | Chemical | 2025/06/13 | Notification|CEP granted|13/06/2025; Administrative procedure|CEP granted|27/02/2024; New application|CEP granted|20/12/2023 |
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| 3035 | Tapentadol hydrochloride | ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100033956;100079880 | CEP 2024-524 - Rev 00 | 2025/06/13 | Valid | 13/06/2030 | Chemical | 2025/06/13 | New application|CEP granted|13/06/2025 |
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