| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1335 | Itraconazole, II | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100089573 | CEP 2025-246 - Rev 01 | 2026/05/19 | Valid | 02/10/2030 | Chemical | 2026/05/19 | Notification|CEP granted|19/05/2026; New application|CEP granted|02/10/2025 |
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| 1827 | Ginkgo dry extract, refined and quantified, DER:35-67:1 | FINZELBERG GMBH & CO. KG Andernach DE | 100014516;100022034 | CEP 2010-220 - Rev 02 | 2026/05/19 | Valid | Herbal | 2026/05/19 | Minor revision|CEP granted|19/05/2026; Minor revision|CEP granted|27/11/2024; Monograph revision|Accepted - CEP remains valid|18/06/2024; Minor revision|Accepted - CEP remains valid|01/12/2021; Minor revision|Accepted - CEP remains valid|23/06/2021; Notification|Rejected|25/05/2021 |
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| 1181 | Buprenorphine hydrochloride, Process II | SIEGFRIED AG Zofingen CH | 100011797;100022117 | CEP 2024-011 - Rev 01 | 2026/05/19 | Valid | 10/06/2029 | Chemical | 2026/05/19 | Notification|CEP granted|19/05/2026; Minor revision|Accepted - CEP remains valid|27/11/2025; New application|CEP granted|11/06/2024 |
|
| 2585 | Rizatriptan benzoate | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2012-108 - Rev 04 | 2026/05/18 | Valid | Chemical | 2026/05/18 | Notification|CEP granted|18/05/2026; Notification|CEP granted|04/04/2025; Notification|CEP granted|05/12/2022; Minor revision|CEP granted|07/01/2022 |
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| 2409 | Diacerein | ARCHIMICA S.P.A Lodi IT | 100012202;100048377 | CEP 2014-247 - Rev 01 | 2026/05/18 | Valid | Chemical | 2026/05/18 | Minor revision|CEP granted|18/05/2026; Renewal|CEP granted|24/06/2021; Monograph revision|CEP granted|04/11/2020 |
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| 1058 | Vancomycin hydrochloride, Precipitated process | ZHEJIANG MEDICINE CO., LTD. Xinchang CN | 100022357;100062098 | CEP 2010-198 - Rev 05 | 2026/05/18 | Valid | Chemical | 2026/05/18 | Minor revision|CEP granted|18/05/2026; Minor revision|CEP granted|28/08/2025; Monograph revision|Accepted - CEP remains valid|31/01/2025; Minor revision|Accepted - CEP remains valid|17/06/2022 |
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| 1142 | Povidone, iodinated | ASHLAND INDUSTRIES EUROPE GMBH Schaffhausen CH | 100040941;100067410 | CEP 2005-007 - Rev 02 | 2026/05/18 | Valid | Chemical | 2026/05/18 | Minor revision|CEP granted|18/05/2026 | ||
| 1058 | Vancomycin hydrochloride, Lyophilised process | ZHEJIANG MEDICINE CO., LTD. Xinchang CN | 100022357;100062098 | CEP 2008-246 - Rev 05 | 2026/05/18 | Valid | Chemical | 2026/05/18 | Minor revision|CEP granted|18/05/2026; Minor revision|CEP granted|28/08/2025; Monograph revision|Accepted - CEP remains valid|31/01/2025; Minor revision|Accepted - CEP remains valid|17/06/2022 |
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| 931 | Metformin Hydrochloride | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2000-059 - Rev 14 | 2026/05/18 | Valid | Chemical | 2026/05/18 | Minor revision|CEP granted|18/05/2026; Minor revision|CEP granted|11/09/2024; Minor revision|CEP granted|23/11/2022; Minor revision|Accepted - CEP remains valid|09/10/2020 |
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| 1058 | Vancomycin hydrochloride, Changhai site (lyophilised process) | ZHEJIANG MEDICINE CO., LTD. Shaoxing CN | 100022357;100084942 | CEP 2023-065 - Rev 02 | 2026/05/18 | Valid | 05/04/2028 | Chemical | 2026/05/18 | Minor revision|CEP granted|18/05/2026; Minor revision|CEP granted|25/08/2025; Monograph revision|Accepted - CEP remains valid|31/01/2025; New application|CEP granted|05/04/2023 |
|
| 2988 | Fingolimod hydrochloride | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2020-108 - Rev 02 | 2026/05/18 | Valid | 30/06/2027 | Chemical | 2026/05/18 | Notification|CEP granted|18/05/2026; Notification|CEP granted|03/04/2025; Monograph revision|Accepted - CEP remains valid|19/04/2024; New application|CEP granted|30/06/2022 |
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| 1680 | Pyrantel embonate, Micronised and non-micronised | MINSHENG GROUP SHAOXING PHARMACEUTICAL CO., LTD. Shaoxing CN | 100023459;100032595 | CEP 2020-321 - Rev 02 | 2026/05/18 | Valid | 13/05/2027 | Chemical | 2026/05/18 | Minor revision|CEP granted|18/05/2026; Notification|Accepted - CEP remains valid|02/01/2025; Minor revision|CEP granted|03/08/2022; New application|CEP granted|16/05/2022 |
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| 2856 | Pirfenidone | ALIVUS LIFE SCIENCES LIMITED Mumbai IN | 100023468;100101905 | CEP 2017-170 - Rev 05 | 2026/05/18 | Valid | Chemical | 2026/05/18 | Notification|CEP granted|18/05/2026; Notification|CEP granted|04/04/2025; Renewal|CEP granted|15/04/2024; Notification|CEP granted|05/12/2022 |
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| 2373 | Meloxicam | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2019-017 - Rev 04 | 2026/05/18 | Valid | Chemical | 2026/05/18 | Renewal|CEP granted|18/05/2026; Major revision|CEP granted|17/07/2023; Minor revision|CEP granted|24/11/2022; Notification|CEP granted|11/07/2022 |
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| 1535 | Levodropropizine | MACLEODS PHARMACEUTICALS LIMITED Mumbai IN | 100021441;100077265 | CEP 2016-174 - Rev 02 | 2026/05/18 | Valid | Chemical | 2026/05/18 | Notification|CEP granted|18/05/2026; Notification|CEP granted|22/04/2026; Renewal|CEP granted|21/10/2022; Major revision|CEP granted|02/08/2022; Monograph revision|Accepted - CEP remains valid|05/05/2020 |
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| 2414 | Octreotide | MATRIX PHARMACORP PRIVATE LIMITED Sangareddy IN | 100051463;100098142 | CEP 2022-031 - Rev 02 | 2026/05/18 | Valid | 07/03/2029 | Chemical | 2026/05/18 | Minor revision|CEP granted|18/05/2026; Notification|CEP granted|22/07/2024; New application|CEP granted|07/03/2024 |
|
| 3151 | Cannabidiol | LINNEA S.A. Locarno CH | 100018975;100027746 | CEP 2024-462 - Rev 01 | 2026/05/18 | Valid | 09/02/2031 | Chemical | 2026/05/18 | Administrative procedure|CEP granted|18/05/2026; New application|CEP granted|09/02/2026 |
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| 3095 | Dabigatran etexilate mesilate, Form 1, Process II | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2024-365 - Rev 00 | 2026/05/18 | Valid | 18/05/2031 | Chemical | 2026/05/18 | New application|CEP granted|18/05/2026 | |
| 2341 | Cefpodoxime proxetil, Process-II | PURE AND CURE HEALTHCARE PRIVATE LIMITED Sahibzada Ajit Singh Nagar IN | 100045639;100075200 | CEP 2025-561 - Rev 00 | 2026/05/18 | Valid | 18/05/2031 | Chemical | 2026/05/18 | New application|CEP granted|18/05/2026 | |
| 1058 | Vancomycin hydrochloride, Changhai site (precipitated process) | ZHEJIANG MEDICINE CO., LTD. Shaoxing CN | 100022357;100084942 | CEP 2023-067 - Rev 03 | 2026/05/18 | Valid | 05/04/2028 | Chemical | 2026/05/18 | Minor revision|CEP granted|18/05/2026; Minor revision|CEP granted|25/08/2025; Monograph revision|CEP granted|03/02/2025; New application|CEP granted|05/04/2023 |
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