| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 662 | Daunorubicin Hydrochloride | ZHEJIANG HISUN PHARMACEUTICAL CO., LTD. Taizhou City CN | 100011825;100018687 | CEP 2012-380 - Rev 03 | 2026/01/30 | Valid | Chemical | 2026/01/30 | Monograph revision|CEP granted|30/01/2026; Minor revision|CEP granted|08/03/2024; Monograph revision|CEP granted|01/08/2023; Notification|Accepted - CEP remains valid|12/09/2022 |
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| 549 | Dexamethasone sodium phosphate | ZHEJIANG XIANJU PHARMACEUTICAL CO., LTD. Taizhou CN | 100022759;100031459 | CEP 2025-277 - Rev 00 | 2026/01/30 | Valid | 30/01/2031 | Chemical | 2026/01/30 | New application|CEP granted|30/01/2026 | |
| 1274 | Tylosin tartrate for veterinary use | ELANCO ANIMAL HEALTH INC. Greenfield US | 100012274;100020462 | CEP 2001-016 - Rev 06 | 2026/01/30 | Valid | Chemical | 2026/01/30 | Notification|CEP granted|30/01/2026; Notification|CEP granted|09/12/2025; Notification|Accepted - CEP remains valid|02/06/2025; Major revision|CEP granted|07/10/2024 |
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| 578 | Ampicillin sodium, Sterile, Process-II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2024-454 - Rev 00 | 2026/01/30 | Valid | 30/01/2031 | Chemical | 2026/01/30 | New application|CEP granted|30/01/2026 | |
| 2124 | Loratadine, Process II, Micronised | QUIMICA SINTETICA S.A. Alcala De Henares ES | 100012121;100019020 | CEP 2025-493 - Rev 00 | 2026/01/30 | Valid | 30/01/2031 | Chemical | 2026/01/30 | New application|CEP granted|30/01/2026 | |
| 432 | Rifamycin sodium | EUROAPI ITALY S.R.L. Brindisi IT | 100039217;100061735 | CEP 2011-233 - Rev 05 | 2026/01/30 | Valid | Chemical | 2026/01/30 | Monograph revision|CEP granted|30/01/2026; Minor revision|CEP granted|09/07/2025; Minor revision|Accepted - CEP remains valid|27/03/2025; Notification|CEP granted|17/12/2021; Notification|Accepted - CEP remains valid|04/08/2021; Notification|CEP granted|09/11/2020 |
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| 417 | Oxygen, Salerno site | SOL S.P.A. Monza IT | 100002061;100001723 | CEP 2025-380 - Rev 00 | 2026/01/30 | Valid | 30/01/2031 | Chemical | 2026/01/30 | New application|CEP granted|30/01/2026 | |
| 1081 | Carboplatin | QILU PHARMACEUTICAL CO., LTD. Jinan CN | 100014051;100061315 | CEP 2010-285 - Rev 05 | 2026/01/30 | Valid | Chemical | 2026/01/30 | Notification|CEP granted|30/01/2026; Notification|CEP granted|23/05/2025; Minor revision|CEP granted|14/02/2024; Notification|Accepted - CEP remains valid|28/01/2022; Notification|CEP granted|16/09/2021 |
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| 2858 | Mometasone furoate monohydrate | STERLING S.p.A. Solomeo Di Corciano IT | 100024377;100033551 | CEP 2018-185 - Rev 02 | 2026/01/30 | Valid | Chemical | 2026/01/30 | Notification|CEP granted|30/01/2026; Renewal|CEP granted|14/10/2024 |
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| 1275 | Ursodeoxycholic acid, UDCA P | ICE S.P.A. Reggio Emilia IT | 100015143;100023828 | CEP 2024-006 - Rev 01 | 2026/01/30 | Valid | 21/08/2029 | Chemical | 2026/01/30 | Monograph revision|CEP granted|30/01/2026; New application|CEP granted|21/08/2024 |
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| 2631 | Rosuvastatin calcium, 1518 | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2023-356 - Rev 01 | 2026/01/29 | Valid | 10/07/2029 | Chemical | 2026/01/29 | Minor revision|CEP granted|29/01/2026; New application|CEP granted|10/07/2024 |
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| 2778 | Sitagliptin phosphate monohydrate, Process-II | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2023-366 - Rev 01 | 2026/01/29 | Valid | 20/03/2029 | Chemical | 2026/01/29 | Major revision|CEP granted|29/01/2026; New application|CEP granted|20/03/2024 |
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| 2234 | Meropenem trihydrate, Sterile, synthetic origin, process I | SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou CN | 100014777;100050265 | CEP 2020-020 - Rev 02 | 2026/01/29 | Valid | Chemical | 2026/01/29 | Renewal|CEP granted|29/01/2026; Minor revision|Accepted - CEP remains valid|30/05/2025; Minor revision|Accepted - CEP remains valid|26/05/2023; Major revision|CEP granted|18/06/2021; New application|CEP granted|22/03/2021 |
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| 1444 | Macrogols, Types 3350 and 4000 | THE DOW CHEMICAL COMPANY Midland US | 100011909;100090025 | CEP 2006-085 - Rev 06 | 2026/01/29 | Valid | Chemical | 2026/01/29 | Minor revision|CEP granted|29/01/2026; Notification|CEP granted|25/04/2025; Administrative procedure|CEP granted|18/09/2024; Minor revision|Accepted - CEP remains valid|06/06/2024; Administrative procedure|CEP granted|29/03/2021; Minor revision|CEP granted|03/02/2021 |
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| 2779 | Solifenacin succinate | SAPTAGIR LABORATORIES PRIVATE LMITED Hyderabad IN | 100042587;100070387 | CEP 2023-384 - Rev 00 | 2026/01/29 | Valid | 29/01/2031 | Chemical | 2026/01/29 | New application|CEP granted|29/01/2026 | |
| 2675 | Irinotecan hydrochloride trihydrate, Form-b | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2017-147 - Rev 01 | 2026/01/29 | Valid | Chemical | 2026/01/29 | Minor revision|CEP granted|29/01/2026; Renewal|CEP granted|04/07/2023; Notification|CEP granted|21/07/2022 |
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| 432 | Rifamycin sodium | CKD BIO CORPORATION Ansan-si KR | 100018976;100029257 | CEP 2010-035 - Rev 03 | 2026/01/27 | Valid | Chemical | 2026/01/27 | Monograph revision|CEP granted|27/01/2026; Minor revision|CEP granted|25/07/2025; Notification|Rejected|19/06/2025; Notification|Accepted - CEP remains valid|25/02/2021 |
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| 2531 | Clopidogrel hydrogen sulfate | IOL CHEMICALS AND PHARMACEUTICALS LIMITED Ludhiana IN | 100017919;100037377 | CEP 2019-006 - Rev 02 | 2026/01/27 | Valid | Chemical | 2026/01/27 | Renewal|CEP granted|27/01/2026; Minor revision|Accepted - CEP remains valid|05/08/2025; Minor revision|Accepted - CEP remains valid|04/08/2022; Administrative procedure|CEP granted|01/06/2021 |
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| 2600 | Olmesartan medoxomil | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2013-297 - Rev 02 | 2026/01/27 | Valid | Chemical | 2026/01/27 | Minor revision|CEP granted|27/01/2026; Minor revision|Accepted - CEP remains valid|21/01/2025; Minor revision|Accepted - CEP remains valid|27/08/2024; Minor revision|CEP granted|12/05/2023; Minor revision|Accepted - CEP remains valid|21/09/2021; Renewal|CEP granted|01/07/2021 |
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| 614 | Glycine | AMINO GMBH Frellstedt DE | 100011599;100021107 | CEP 2013-179 - Rev 02 | 2026/01/27 | Valid | Chemical | 2026/01/27 | Minor revision|CEP granted|27/01/2026; Notification|Accepted - CEP remains valid|13/09/2023; Minor revision|CEP granted|08/07/2022; Renewal|CEP granted|31/05/2021 |
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