| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 388 | Dexamethasone, Process II | TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN | 100011805;100018616 | CEP 2020-270 - Rev 01 | 2025/12/02 | Valid | 31/03/2027 | Chemical and TSE | 2025/12/02 | Minor revision|CEP granted|02/12/2025; New application|CEP granted|31/03/2022 |
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| 1750 | Fluticasone propionate, Micronised | HOVIONE FARMACIENCIA S.A. Loures PT | 100001467;100000315 | CEP 2005-160 - Rev 03 | 2025/12/02 | Valid | Chemical | 2025/12/02 | Minor revision|CEP granted|02/12/2025; Monograph revision|Accepted - CEP remains valid|15/04/2021; Minor revision|Accepted - CEP remains valid|13/10/2020; Notification|Rejected|06/07/2020 |
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| 2751 | Valaciclovir hydrochloride hydrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2018-102 - Rev 04 | 2025/12/01 | Valid | Chemical | 2025/12/01 | Notification|CEP granted|01/12/2025; Renewal|CEP granted|25/04/2025; Minor revision|Accepted - CEP remains valid|20/08/2024; Minor revision|CEP granted|20/02/2024; Minor revision|Accepted - CEP remains valid|27/01/2021; Minor revision|CEP granted|07/08/2020 |
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| 1511 | Enoxolone | ALCHEM INTERNATIONAL PRIVATE LIMITED Faridabad IN | 100011947;100018683 | CEP 2018-263 - Rev 02 | 2025/12/01 | Valid | Chemical | 2025/12/01 | Renewal|CEP granted|01/12/2025; Monograph revision|CEP granted|22/06/2023; Minor revision|Accepted - CEP remains valid|03/08/2022 |
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| 2896 | Thiocolchicoside crystallised from ethanol | ALCHEM INTERNATIONAL PRIVATE LIMITED Faridabad IN | 100011947;100018683 | CEP 2018-128 - Rev 01 | 2025/12/01 | Valid | Chemical | 2025/12/01 | Renewal|CEP granted|01/12/2025 | ||
| 626 | Neostigmine metilsulfate | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | 100011732;100018657 | CEP 2016-044 - Rev 01 | 2025/12/01 | Valid | Chemical | 2025/12/01 | Minor revision|CEP granted|01/12/2025; Renewal|CEP granted|09/09/2022; Minor revision|CEP granted|16/12/2020 |
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| 561 | Methylprednisolone, Micronised | SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN | 100018972;100095999 | CEP 2014-015 - Rev 02 | 2025/12/01 | Valid | Chemical | 2025/12/01 | Minor revision|CEP granted|01/12/2025; Minor revision|CEP granted|03/05/2022 |
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| 1470 | Simeticone | EV PRODUZIONE S.R.L. Trecate IT | 100054964;100097557 | CEP 2006-140 - Rev 02 | 2025/12/01 | Valid | Chemical | 2025/12/01 | Notification|CEP granted|01/12/2025; Transfer of holdership|CEP granted|30/05/2025 |
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| 2751 | Valaciclovir hydrochloride hydrate, Site-II | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2024-054 - Rev 02 | 2025/12/01 | Valid | 06/05/2029 | Chemical | 2025/12/01 | Notification|CEP granted|01/12/2025; Minor revision|CEP granted|13/12/2024; New application|CEP granted|06/05/2024 |
|
| 11 | Benzocaine | APEX HEALTHCARE LIMITED Ankleshwar IN | 100039365;100061975 | CEP 2022-102 - Rev 01 | 2025/12/01 | Valid | 09/08/2028 | Chemical | 2025/12/01 | Minor revision|CEP granted|01/12/2025; New application|CEP granted|09/08/2023 |
|
| 1783 | Glycopyrronium bromide, Micronised, non-micronised | MELODY HEALTHCARE PRIVATE LIMITED Mumbai IN | 100014822;100073679 | CEP 2021-222 - Rev 02 | 2025/12/01 | Valid | 19/12/2027 | Chemical | 2025/12/01 | Minor revision|CEP granted|01/12/2025; Administrative procedure|CEP granted|16/01/2023; New application|CEP granted|19/12/2022 |
|
| 2582 | Donepezil hydrochloride, Monohydrate | VASUDHA PHARMA CHEM LIMITED Hyderabad IN | 100011811;100018603 | CEP 2024-041 - Rev 00 | 2025/12/01 | Valid | 01/12/2030 | Chemical | 2025/12/01 | New application|CEP granted|01/12/2025 | |
| 2932 | Rivaroxaban, Micronised, non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2021-017 - Rev 01 | 2025/12/01 | Valid | 17/02/2027 | Chemical | 2025/12/01 | Minor revision|CEP granted|01/12/2025; Minor revision|Accepted - CEP remains valid|17/05/2022; New application|CEP granted|17/02/2022 |
|
| 1558 | Propofol | EMCURE PHARMACEUTICALS LIMITED Pune IN | 100011677;100022690 | CEP 2020-203 - Rev 02 | 2025/12/01 | Valid | Chemical | 2025/12/01 | Renewal|CEP granted|01/12/2025; Notification|CEP granted|25/08/2023; Major revision|Rejected|09/05/2023; New application|CEP granted|05/01/2021 |
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| 2232 | Losartan potassium, Form-1 | DIVI'S LABORATORIES LIMITED Hyderabad IN | 100011666;100052116 | CEP 2024-430 - Rev 00 | 2025/12/01 | Valid | 01/12/2030 | Chemical | 2025/12/01 | New application|CEP granted|01/12/2025 | |
| 1141 | Potassium hydrogen carbonate | EMNAR PHARMA PRIVATE LIMITED Hyderabad IN | 100033980;100065255 | CEP 2025-387 - Rev 00 | 2025/12/01 | Valid | 01/12/2030 | Chemical | 2025/12/01 | New application|CEP granted|01/12/2025 | |
| 1076 | Bumetanide | SUZHOU LIXIN PHARMACEUTICAL CO., LTD. Suzhou CN | 100012102;100019568 | CEP 2024-381 - Rev 00 | 2025/12/01 | Valid | 01/12/2030 | Chemical | 2025/12/01 | New application|CEP granted|01/12/2025 | |
| 1014 | Fluphenazine Decanoate | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2024-235 - Rev 00 | 2025/11/27 | Valid | 27/11/2030 | Chemical | 2025/11/27 | New application|CEP granted|27/11/2025 | |
| 3115 | Levocetirizine dihydrochloride | EGIS Pharmaceuticals PLC Budapest HU | 100001091;100001662 | CEP 2023-391 - Rev 00 | 2025/11/27 | Valid | 27/11/2030 | Chemical | 2025/11/27 | New application|CEP granted|27/11/2025 | |
| 2736 | Imatinib mesilate, β-Form | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2025-099 - Rev 00 | 2025/11/27 | Valid | 27/11/2030 | Chemical | 2025/11/27 | New application|CEP granted|27/11/2025 |
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