| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| 1473 | Soya-bean oil, refined, IV | SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint-Laurent Blangy FR | 100018152;100094230 | CEP 2011-115 - Rev 03 | 2025/01/16 | Valid | Chemical | 2025/01/16 | Notification|CEP granted|16/01/2025; Minor revision|Accepted - CEP remains valid|26/08/2024; Minor revision|CEP granted|27/11/2023; Minor revision|Accepted - CEP remains valid|15/09/2021 |
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| 1473 | Soya-bean oil, refined, BXR EU, antioxidant ascorbyl palmitate | SOCIETE INDUSTRIELLE DES OLEAGINEUX SIO Saint-Laurent Blangy FR | 100018152;100094230 | CEP 2012-336 - Rev 02 | 2025/01/16 | Valid | Chemical | 2025/01/16 | Notification|CEP granted|16/01/2025; Minor revision|Accepted - CEP remains valid|26/08/2024; Minor revision|Accepted - CEP remains valid|09/03/2022; Major revision|CEP granted|15/09/2020 |
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| 1559 | Risperidone | TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN | 100004452;100001862 | CEP 2004-160 - Rev 04 | 2025/01/15 | Valid | Chemical | 2025/01/15 | Minor revision|CEP granted|15/01/2025; Minor revision|CEP granted|27/10/2023; Notification|CEP granted|27/05/2020 |
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| 1451 | Mupirocin calcium, Micronised | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN | 100016034;100024777 | CEP 2013-236 - Rev 04 | 2025/01/15 | Valid | Chemical | 2025/01/15 | Minor revision|CEP granted|15/01/2025; Administrative procedure|CEP granted|04/01/2022; Minor revision|CEP granted|17/12/2021; Minor revision|CEP granted|24/06/2021; Minor revision|Accepted - CEP remains valid|17/08/2020 |
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| 1065 | Alprazolam | FERMION OY Espoo FI | 100011508;100020280 | CEP 2007-365 - Rev 02 | 2025/01/15 | Valid | Chemical | 2025/01/15 | Minor revision|CEP granted|15/01/2025; Minor revision|Accepted - CEP remains valid|17/10/2022 |
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| 888 | Ciprofloxacin Hydrochloride | AARTI DRUGS LIMITED Mumbai IN | 100014953;100023652 | CEP 2005-119 - Rev 06 | 2025/01/15 | Valid | Chemical | 2025/01/15 | Minor revision|CEP granted|15/01/2025; Minor revision|CEP granted|21/08/2024 |
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| 2177 | Lufenuron for veterinary use | ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN | 100033528;100052489 | CEP 2023-125 - Rev 00 | 2025/01/15 | Valid | 15/01/2030 | Chemical | 2025/01/15 | New application|CEP granted|15/01/2025 | |
| 2757 | Aprepitant, Form I | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100078783 | CEP 2022-033 - Rev 00 | 2025/01/15 | Valid | 15/01/2030 | Chemical | 2025/01/15 | New application|CEP granted|15/01/2025 | |
| 615 | Guaifenesin, Unit-II | SYNTHOKEM LABS PRIVATE LIMITED Hyderabad IN | 100018775;100027570 | CEP 2019-065 - Rev 01 | 2025/01/15 | Valid | Chemical | 2025/01/15 | Renewal|CEP granted|15/01/2025; Minor revision|Accepted - CEP remains valid|30/05/2022; Notification|Rejected|10/11/2021 |
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| 312 | Betamethasone | AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN | 100011968;100018590 | CEP 2022-196 - Rev 02 | 2025/01/15 | Valid | 13/11/2029 | Chemical | 2025/01/15 | Administrative procedure|CEP granted|15/01/2025; Minor revision|CEP granted|19/12/2024; New application|CEP granted|13/11/2024 |
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| 2815 | Entecavir monohydrate | DONG BANG FUTURE TECH & LIFE CO., LTD. Hwaseong-si KR | 100024414;100042624 | CEP 2018-093 - Rev 01 | 2025/01/15 | Valid | Chemical | 2025/01/15 | Renewal|CEP granted|15/01/2025 | ||
| 2235 | Methylphenidate hydrochloride, Process II | HARMAN FINOCHEM LIMITED Mumbai IN | 100011528;100020515 | CEP 2021-474 - Rev 01 | 2025/01/15 | Valid | 25/05/2027 | Chemical | 2025/01/15 | Minor revision|CEP granted|15/01/2025; New application|CEP granted|25/05/2022 |
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| 2765 | Eplerenone, Process code - EPLB, Micronised (FA, FC) | AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN | 100011968;100018590 | CEP 2019-028 - Rev 02 | 2025/01/14 | Valid | Chemical | 2025/01/14 | Renewal|CEP granted|14/01/2025; Notification|Accepted - CEP remains valid|22/11/2022; Minor revision|Accepted - CEP remains valid|21/09/2021; Notification|Accepted - CEP remains valid|07/12/2020; Minor revision|CEP granted|26/10/2020 |
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