| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| 653 | Baclofen | COHANCE LIFESCIENCES LIMITED Mumbai IN | 100011755;100090273 | CEP 2018-280 - Rev 03 | 2026/01/27 | Valid | 17/06/2026 | Chemical | 2026/01/27 | Monograph revision|CEP granted|27/01/2026; Minor revision|CEP granted|22/01/2025; Notification|CEP granted|15/12/2022 |
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| 2778 | Sitagliptin phosphate monohydrate | ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. Taizhou City CN | 100012174;100018701 | CEP 2020-037 - Rev 02 | 2026/01/27 | Valid | 13/07/2026 | Chemical | 2026/01/27 | Minor revision|CEP granted|27/01/2026; Notification|Accepted - CEP remains valid|06/08/2025; Minor revision|CEP granted|20/09/2023; New application|CEP granted|13/07/2021 |
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| 645 | Tobramycin, EHS Optimized Process | CHONGQING DAXIN PHARMACEUTICAL CO., LTD. Shuitu Town CN | 100011996;100039007 | CEP 2019-036 - Rev 02 | 2026/01/27 | Valid | Chemical | 2026/01/27 | Monograph revision|CEP granted|27/01/2026; Renewal|CEP granted|31/07/2024 |
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| 1573 | Sumatriptan succinate | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2024-042 - Rev 00 | 2026/01/27 | Valid | 27/01/2031 | Chemical | 2026/01/27 | New application|CEP granted|27/01/2026 | |
| 922 | Ketoprofen | ANLON HEALTHCARE LIMITED Gondal IN | 100049220;100083386 | CEP 2023-344 - Rev 01 | 2026/01/27 | Valid | 31/01/2030 | Chemical | 2026/01/27 | Minor revision|CEP granted|27/01/2026; New application|CEP granted|31/01/2025 |
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| 1363 | Prilocaine Hydrochloride | SWATI SPENTOSE PRIVATE LIMITED Mumbai IN | 100021605;100052219 | CEP 2021-035 - Rev 01 | 2026/01/27 | Valid | 14/04/2030 | Chemical | 2026/01/27 | Minor revision|CEP granted|27/01/2026; New application|CEP granted|14/04/2025 |
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| 2993 | Nilotinib hydrochloride monohydrate, Form-B | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2023-226 - Rev 00 | 2026/01/26 | Valid | 26/01/2031 | Chemical | 2026/01/26 | New application|CEP granted|26/01/2026 | |
| 2423 | Valsartan | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2010-065 - Rev 09 | 2026/01/26 | Valid | Chemical | 2026/01/26 | Minor revision|CEP granted|26/01/2026; Minor revision|CEP granted|27/09/2024; Minor revision|CEP granted|18/10/2023; Minor revision|CEP granted|06/10/2020 |
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| 2631 | Rosuvastatin calcium, Amorphous | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2017-069 - Rev 05 | 2026/01/26 | Valid | Chemical | 2026/01/26 | Notification|CEP granted|26/01/2026; Renewal|CEP granted|28/03/2024; Minor revision|Accepted - CEP remains valid|31/01/2022; Minor revision|CEP granted|06/07/2021; Monograph revision|CEP granted|05/05/2020; Notification|CEP granted|29/01/2020 |
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