| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 934 | Metronidazole benzoate | ACHARYA CHEMICALS Dombivli (East) IN | 100023843;100094052 | CEP 2007-056 - Rev 04 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Minor revision|CEP granted|20/01/2025; Notification|Rejected|10/12/2024; Administrative procedure|CEP granted|05/04/2023 |
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| 2777 | Pregabalin | SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN | 100018880;100027661 | CEP 2018-169 - Rev 01 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Renewal|CEP granted|20/01/2025 | ||
| 1191 | Clozapine | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2021-110 - Rev 01 | 2025/01/20 | Valid | 08/07/2027 | Chemical | 2025/06/13 | Minor revision|Accepted - CEP remains valid|13/06/2025; Minor revision|CEP granted|20/01/2025; New application|CEP granted|08/07/2022 |
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| 1745 | Carvedilol | CTX LIFESCIENCES PVT. LIMITED Surat IN | 100019102;100027863 | CEP 2014-201 - Rev 02 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Minor revision|CEP granted|20/01/2025; Minor revision|CEP granted|05/04/2022; Renewal|CEP granted|18/06/2021 |
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| 2335 | Ropivacaine hydrochloride monohydrate | SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN | 100048410;100080174 | CEP 2023-148 - Rev 01 | 2025/01/20 | Valid | 25/09/2029 | Chemical | 2025/01/20 | Minor revision|CEP granted|20/01/2025; New application|CEP granted|25/09/2024 |
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| 752 | Alanine | AMINO GMBH Frellstedt DE | 100011599;100021107 | CEP 2013-157 - Rev 02 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Notification|CEP granted|20/01/2025; Minor revision|CEP granted|31/05/2023 |
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| 1188 | Cefixime | PURE AND CURE HEALTHCARE PRIVATE LIMITED Punjab IN | 100045639;100075200 | CEP 2009-005 - Rev 02 | 2025/01/20 | Valid | Chemical | 2025/01/20 | Notification|CEP granted|20/01/2025; Transfer of holdership|CEP granted|13/01/2022 |
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| 578 | Ampicillin sodium, Sterile, Enzymatic route | SANDOZ GMBH Kundl AT | 100000546;100000450 | CEP 2024-480 - Rev 00 | 2025/01/20 | Valid | 20/01/2030 | Chemical | 2025/01/20 | New application|CEP granted|20/01/2025 | |
| 1089 | Ciprofloxacin | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN | 100022562;100093113 | CEP 2020-120 - Rev 03 | 2025/01/17 | Valid | 11/06/2026 | Chemical | 2025/01/17 | Minor revision|CEP granted|17/01/2025; Minor revision|CEP granted|03/07/2024; Minor revision|CEP granted|26/10/2022; New application|CEP granted|11/06/2021 |
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| 2232 | Losartan potassium | SYNERGENE ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100038855;100091886 | CEP 2023-049 - Rev 00 | 2025/01/17 | Valid | 17/01/2030 | Chemical | 2025/01/17 | New application|CEP granted|17/01/2025 | |
| 1456 | Olive oil, refined, BXR EU refined olive oil | SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint-Laurent Blangy FR | 100018152;100094230 | CEP 2012-333 - Rev 01 | 2025/01/17 | Valid | Chemical | 2025/10/30 | Minor revision|Accepted - CEP remains valid|30/10/2025; Notification|CEP granted|17/01/2025; Minor revision|Accepted - CEP remains valid|27/08/2024; Minor revision|Accepted - CEP remains valid|09/03/2022; Minor revision|Accepted - CEP remains valid|06/07/2020 |
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| 335 | Hydrocortisone, Non-micronised, micronised | SHANDONG XINHUA PHARMACEUTICAL CO., LTD. Zibo CN | 100011788;100019607 | CEP 2019-176 - Rev 01 | 2025/01/17 | Valid | 06/10/2026 | Chemical | 2025/01/17 | Minor revision|CEP granted|17/01/2025; Notification|Accepted - CEP remains valid|24/06/2024 |
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| 2702 | Chlormadinone acetate, Micronised (grade 21), non-micronised | FARMABIOS S.p.A Gropello Cairoli IT | 100011643;100021232 | CEP 2018-122 - Rev 04 | 2025/01/17 | Valid | Chemical | 2025/01/17 | Renewal|CEP granted|17/01/2025; Minor revision|CEP granted|07/09/2023; Minor revision|CEP granted|18/12/2020; Minor revision|CEP granted|13/05/2020 |
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| 1286 | Alfacalcidol | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2000-100 - Rev 07 | 2025/01/17 | Valid | Chemical | 2025/01/17 | Administrative procedure|CEP granted|17/01/2025; Notification|CEP granted|13/01/2025; Notification|Accepted - CEP remains valid|22/02/2024; Notification|Accepted - CEP remains valid|05/08/2022; Notification|CEP granted|20/12/2021; Minor revision|CEP granted|26/05/2021 |
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| 711 | Cyclophosphamide monohydrate, Milled and non milled | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | 100011732;100023530 | CEP 2018-092 - Rev 02 | 2025/01/17 | Valid | Chemical | 2025/01/17 | Renewal|CEP granted|17/01/2025; Monograph revision|CEP granted|23/08/2023 |
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| 1699 | Mesalazine | IOL CHEMICALS AND PHARMACEUTICALS LTD Ludhiana IN | 100017919;100037377 | CEP 2023-339 - Rev 00 | 2025/01/16 | Valid | 16/01/2030 | Chemical | 2025/01/16 | New application|CEP granted|16/01/2025 | |
| 198 | Oxytetracycline hydrochloride | INNER MONGOLIA GLINT PHARMACEUTICAL CO., LTD. Chifeng CN | 100039247;100061785 | CEP 2021-412 - Rev 02 | 2025/01/16 | Valid | 12/12/2027 | Chemical | 2025/01/16 | Monograph revision|CEP granted|16/01/2025; Minor revision|CEP granted|06/04/2023; New application|CEP granted|12/12/2022 |
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| 2675 | Irinotecan hydrochloride trihydrate, Process 2, Form b | SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN | 100044578;100073706 | CEP 2019-156 - Rev 02 | 2025/01/16 | Valid | Chemical | 2025/01/16 | Renewal|CEP granted|16/01/2025; Notification|CEP granted|21/07/2022 |
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| 23 | Diphenhydramine hydrochloride | QIDONG DONGYUE PHARMACEUTICAL CO., LTD. Qidong CN | 100012994;100023425 | CEP 2023-023 - Rev 00 | 2025/01/16 | Valid | 16/01/2030 | Chemical | 2025/01/16 | New application|CEP granted|16/01/2025 | |
| 1456 | Olive oil, refined, For parenteral use | SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint-Laurent Blangy FR | 100018152;100094230 | CEP 2015-167 - Rev 02 | 2025/01/16 | Valid | Chemical | 2025/01/16 | Notification|CEP granted|16/01/2025; Minor revision|CEP granted|06/02/2024; Minor revision|Accepted - CEP remains valid|16/03/2022; Renewal|CEP granted|24/08/2020 |
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