| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2358 | Teicoplanin, Process II | LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD. Fuzhou CN | 100020920;100029633 | CEP 2025-047 - Rev 00 | 2025/06/18 | Valid | 18/06/2030 | Chemical | 2025/06/18 | New application|CEP granted|18/06/2025 | |
| 272 | Doxycycline hyclate, Process Ⅱ | SHANDONG GUOBANG PHARMACEUTICAL CO., LTD. Weifang CN | 100036834;100058198 | CEP 2025-191 - Rev 00 | 2025/06/18 | Valid | 18/06/2030 | Chemical | 2025/06/18 | New application|CEP granted|18/06/2025 | |
| 2404 | Drospirenone, Code 202900 | STERLING CHEMICAL MALTA LTD. Birzebbugia MT | 100021162;100039059 | CEP 2023-457 - Rev 00 | 2025/06/18 | Valid | 18/06/2030 | Chemical | 2025/06/18 | New application|CEP granted|18/06/2025 | |
| 2307 | Modafinil | SYMED LABS LIMITED Hyderabad IN | 100018727;100053490 | CEP 2024-098 - Rev 00 | 2025/06/18 | Valid | 18/06/2030 | Chemical | 2025/06/18 | New application|CEP granted|18/06/2025 | |
| 2284 | Calcipotriol monohydrate | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2014-016 - Rev 02 | 2025/06/17 | Valid | Chemical | 2025/06/17 | Notification|CEP granted|17/06/2025; Notification|CEP granted|20/12/2021 |
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| 698 | Warfarin sodium | CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100053345;100094249 | CEP 2008-321 - Rev 02 | 2025/06/17 | Valid | Chemical | 2025/06/17 | Notification|CEP granted|17/06/2025 | ||
| 57 | Tetracaine hydrochloride | CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100053345;100094249 | CEP 2010-256 - Rev 02 | 2025/06/17 | Valid | Chemical | 2025/06/17 | Notification|CEP granted|17/06/2025; Monograph revision|Accepted - CEP remains valid|20/04/2022 |
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| 2541 | Quetiapine Fumarate, Process-II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2023-005 - Rev 02 | 2025/06/17 | Valid | 12/12/2028 | Chemical | 2025/06/17 | Minor revision|CEP granted|17/06/2025; Notification|Rejected|15/05/2025; Notification|CEP granted|12/04/2024; New application|CEP granted|12/12/2023 |
|
| 253 | Ascorbic acid | NORTHEAST PHARMACEUTICAL GROUP CO. LTD Shenyang CN | 100021339;100054155 | CEP 2022-066 - Rev 01 | 2025/06/17 | Valid | 14/06/2029 | Chemical | 2025/06/17 | Notification|CEP granted|17/06/2025; New application|CEP granted|14/06/2024 |
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| 699 | Warfarin sodium clathrate | CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100053345;100094249 | CEP 2021-450 - Rev 01 | 2025/06/17 | Valid | 05/02/2029 | Chemical | 2025/06/17 | Notification|CEP granted|17/06/2025; New application|CEP granted|05/02/2024 |
|
| 2054 | Clofazimine, Triclinic form | MIDAS PHARMA GMBH Ingelheim am Rhein DE | 100001328;100004656 | CEP 2019-257 - Rev 02 | 2025/06/17 | Valid | 15/10/2026 | Chemical | 2025/06/17 | Minor revision|CEP granted|17/06/2025; Notification|CEP granted|27/01/2023; Minor revision|Accepted - CEP remains valid|16/02/2022 |
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| 2778 | Sitagliptin phosphate monohydrate, 1567 | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2024-229 - Rev 01 | 2025/06/17 | Valid | 10/04/2030 | Chemical | 2025/06/17 | Minor revision|CEP granted|17/06/2025; New application|CEP granted|10/04/2025 |
|
| 922 | Ketoprofen | SNJ LIFECARE PRIVATE LIMITED 363 650 IN | 100051847;100091285 | CEP 2024-281 - Rev 00 | 2025/06/17 | Valid | 17/06/2030 | Chemical | 2025/06/17 | New application|CEP granted|17/06/2025 | |
| 2306 | Gemcitabine hydrochloride | FARMHISPANIA S.A. Montmeló ES | 100011645;100022190 | CEP 2024-203 - Rev 00 | 2025/06/17 | Valid | 17/06/2030 | Chemical | 2026/02/26 | Notification|Accepted - CEP remains valid|26/02/2026; 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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