| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 3139 | Brivaracetam, Non-micronised and micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2024-064 - Rev 01 | 2025/12/04 | Valid | 25/02/2030 | Chemical | 2025/12/04 | Minor revision|CEP granted|04/12/2025; New application|CEP granted|25/02/2025 |
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| 2296 | Pantoprazole sodium sesquihydrate, Process III | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-346 - Rev 00 | 2025/12/04 | Valid | 04/12/2030 | Chemical | 2025/12/04 | New application|CEP granted|04/12/2025 | |
| 2775 | Nebivolol hydrochloride | ALKEM LABORATORIES LIMITED Mumbai IN | 100005554;100010367 | CEP 2024-481 - Rev 00 | 2025/12/04 | Valid | 04/12/2030 | Chemical | 2025/12/04 | New application|CEP granted|04/12/2025 | |
| 3052 | Lercanidipine hydrochloride, Amorphous | MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN | 100020971;100029680 | CEP 2024-409 - Rev 00 | 2025/12/04 | Valid | 04/12/2030 | Chemical | 2025/12/04 | New application|CEP granted|04/12/2025 | |
| 2741 | Sulfadimethoxine | ANUH PHARMA LTD. Mumbai IN | 100021566;100030259 | CEP 2024-522 - Rev 00 | 2025/12/04 | Valid | 04/12/2030 | Chemical | 2025/12/04 | New application|CEP granted|04/12/2025 | |
| 1491 | Amlodipine besilate, Site-II | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2025-407 - Rev 00 | 2025/12/04 | Valid | 04/12/2030 | Chemical | 2025/12/04 | New application|CEP granted|04/12/2025 | |
| 937 | Minoxidil | IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN | 100017919;100037377 | CEP 2024-558 - Rev 00 | 2025/12/04 | Valid | 04/12/2030 | Chemical | 2025/12/04 | New application|CEP granted|04/12/2025 | |
| 2583 | Montelukast sodium | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2024-125 - Rev 00 | 2025/12/03 | Valid | 03/12/2030 | Chemical | 2025/12/03 | New application|CEP granted|03/12/2025 | |
| 391 | Furosemide, Alternative process | SRI KRISHNA PHARMACEUTICALS LIMITED Hyderabad IN | 100015104;100023787 | CEP 2013-273 - Rev 01 | 2025/12/03 | Valid | Chemical | 2025/12/03 | Minor revision|CEP granted|03/12/2025; Minor revision|Accepted - CEP remains valid|20/09/2022; Minor revision|Accepted - CEP remains valid|21/03/2022 |
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| 3095 | Dabigatran etexilate mesilate | HIKAL LIMITED Bangalore IN | 100014769;100023445 | CEP 2024-363 - Rev 00 | 2025/12/03 | Valid | 03/12/2030 | Chemical | 2025/12/03 | New application|CEP granted|03/12/2025 | |
| 930 | Lysine Hydrochloride | EVONIK REXIM S.A.S. Ham FR | 100012329;100020964 | CEP 2003-057 - Rev 06 | 2025/12/03 | Valid | Chemical | 2025/12/03 | Minor revision|CEP granted|03/12/2025; Notification|CEP granted|04/04/2022 |
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| 2617 | Aripiprazole | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2014-188 - Rev 02 | 2025/12/03 | Valid | Chemical | 2025/12/03 | Administrative procedure|CEP granted|03/12/2025; Minor revision|CEP granted|07/11/2025; Renewal|CEP granted|02/06/2021; Minor revision|Accepted - CEP remains valid|12/10/2020 |
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| 3087 | Ticagrelor | Changzhou Pharmaceutical Factory Changzhou CN | 100012704;100018611 | CEP 2021-333 - Rev 02 | 2025/12/03 | Valid | 26/05/2028 | Chemical | 2025/12/03 | Minor revision|CEP granted|03/12/2025; Minor revision|CEP granted|26/08/2024; New application|CEP granted|30/05/2023 |
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| 1732 | Norgestimate, Optimized process | STERLING S.p.A. Solomeo Di Corciano IT | 100024377;100033551 | CEP 2021-049 - Rev 03 | 2025/12/03 | Valid | 03/01/2027 | Chemical | 2025/12/03 | Minor revision|CEP granted|03/12/2025; Notification|CEP granted|12/10/2022; Minor revision|Rejected|03/02/2023; Minor revision|CEP granted|13/04/2022; New application|CEP granted|03/01/2022 |
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| 665 | Econazole nitrate, Powder, micronised | PMC ISOCHEM Vert Le Petit FR | 100011861;100020972 | CEP 2019-074 - Rev 02 | 2025/12/03 | Valid | Chemical | 2025/12/03 | Renewal|CEP granted|03/12/2025; Minor revision|CEP granted|08/04/2025 |
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| 1655 | Mitomycin | CONCORD BIOTECH LIMITED Ahmedabad IN | 100005519;100000897 | CEP 2019-308 - Rev 01 | 2025/12/02 | Valid | Chemical | 2025/12/02 | Renewal|CEP granted|02/12/2025 | ||
| 2330 | Leflunomide | MAPRIMED S.A. Buenos Aires AR | 100012039;100018552 | CEP 2018-252 - Rev 03 | 2025/12/02 | Valid | Chemical | 2025/12/02 | Renewal|CEP granted|02/12/2025; Minor revision|CEP granted|03/06/2025; Notification|Accepted - CEP remains valid|04/12/2023; Minor revision|CEP granted|27/10/2022; Minor revision|Rejected|24/05/2022 |
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| 2119 | Venlafaxine hydrochloride, Standard and milled, form II | MOEHS IBERICA S.L. Rubi ES | 100029092;100068825 | CEP 2006-182 - Rev 05 | 2025/12/02 | Valid | Chemical | 2025/12/02 | Minor revision|CEP granted|02/12/2025; Notification|Accepted - CEP remains valid|21/02/2023; Minor revision|Accepted - CEP remains valid|28/07/2022; Minor revision|Accepted - CEP remains valid|28/03/2022; Minor revision|Accepted - CEP remains valid|24/01/2022; Minor revision|Accepted - CEP remains valid|19/03/2021 |
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| 748 | Vinblastine Sulfate, Process 2 | MINAKEM HIGH POTENT Mont-Saint-Guibert BE | 100011725;100022401 | CEP 2020-065 - Rev 02 | 2025/12/02 | Valid | Chemical | 2025/12/02 | Renewal|CEP granted|02/12/2025; Notification|Accepted - CEP remains valid|02/04/2024; Minor revision|CEP granted|17/07/2023; New application|CEP granted|09/09/2020 |
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| 1449 | Mometasone furoate, Micronised | STERLING S.p.A. Solomeo Di Corciano IT | 100024377;100033551 | CEP 2025-335 - Rev 01 | 2025/12/02 | Valid | 17/11/2030 | Chemical | 2025/12/02 | Minor revision|CEP granted|02/12/2025; New application|CEP granted|17/11/2025 |
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