| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1783 | Glycopyrronium bromide | FDC Limited Mumbai IN | 100011646;100021030 | CEP 2024-110 - Rev 00 | 2025/03/28 | Valid | 28/03/2030 | Chemical | 2025/03/28 | New application|CEP granted|28/03/2025 | |
| 2535 | Levetiracetam | ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN | 100022703;100031392 | CEP 2012-072 - Rev 01 | 2025/03/27 | Withdrawn by Holder | 2025/06/04 | Chemical | 2025/03/27 | ||
| 1724 | Formoterol fumarate dihydrate, Micronised, non-micronised | Inke, S.A. Castellbisbal ES | 100020253;100029013 | CEP 2006-024 - Rev 03 | 2025/03/27 | Valid | Chemical | 2025/03/27 | Minor revision|CEP granted|27/03/2025; Monograph revision|Accepted - CEP remains valid|06/05/2022; Minor revision|CEP granted|15/10/2020 |
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| 1368 | Ramipril | ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. Taizhou CN | 100022703;100031392 | CEP 2010-176 - Rev 01 | 2025/03/27 | Valid | Chemical | 2025/03/27 | Notification|CEP granted|27/03/2025 | ||
| 311 | Aluminium oxide, hydrated, 0200 | SPI PHARMA, INC. Wilmington US | 100018352;100042876 | CEP 2008-264 - Rev 01 | 2025/03/26 | Valid | Chemical | 2025/03/26 | Monograph revision|CEP granted|26/03/2025 | ||
| 1081 | Carboplatin | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2003-155 - Rev 04 | 2025/03/26 | Valid | Chemical | 2025/03/26 | Major revision|CEP granted|26/03/2025; Minor revision|CEP granted|14/12/2023 |
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| 734 | Prednisolone acetate | EUROAPI FRANCE Vertolaye FR | 100039327;100061906 | CEP 2000-025 - Rev 07 | 2025/03/26 | Valid | Chemical | 2025/03/26 | Minor revision|CEP granted|26/03/2025; Transfer of holdership|CEP granted|16/12/2021; Minor revision|CEP granted|04/06/2020 |
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| 293 | Spiramycin | EUROAPI ITALY S.R.L. Brindisi IT | 100039217;100061735 | CEP 2010-032 - Rev 04 | 2025/03/26 | Valid | Chemical and TSE | 2025/12/03 | Notification|Accepted - CEP remains valid|03/12/2025; Minor revision|CEP granted|26/03/2025; Notification|Accepted - CEP remains valid|04/07/2024; Transfer of holdership|CEP granted|17/12/2021; Notification|CEP granted|09/11/2020; Notification|CEP granted|24/03/2020 |
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| 1188 | Cefixime | QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN | 100033695;100052910 | CEP 2014-213 - Rev 01 | 2025/03/26 | Valid | Chemical | 2025/03/26 | Minor revision|CEP granted|26/03/2025; Minor revision|Accepted - CEP remains valid|10/05/2022; Renewal|CEP granted|19/02/2021 |
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| 1368 | Ramipril, Process-II | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2021-281 - Rev 01 | 2025/03/26 | Valid | 20/05/2027 | Chemical | 2025/08/21 | Minor revision|Accepted - CEP remains valid|21/08/2025; Minor revision|CEP granted|26/03/2025; Minor revision|Accepted - CEP remains valid|13/02/2023; New application|CEP granted|20/05/2022 |
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| 1472 | Sodium hyaluronate, Intrinsic viscosity 1.28 m3/kg; 1.63 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use | KEWPIE CORP. Tokyo JP | 100039277;100093553 | CEP 2018-037 - Rev 03 | 2025/03/26 | Valid | Chemical and TSE | 2025/03/26 | Notification|CEP granted|26/03/2025; Renewal|CEP granted|21/02/2025; Minor revision|Accepted - CEP remains valid|11/08/2022; Minor revision|CEP granted|24/03/2021 |
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| 1589 | Doxylamine hydrogen succinate, Grade II | R L FINE CHEM PVT. LTD. Gowribidanur IN | 100016723;100053383 | CEP 2021-283 - Rev 02 | 2025/03/26 | Valid | 25/10/2026 | Chemical | 2025/03/26 | Minor revision|CEP granted|26/03/2025; Minor revision|CEP granted|08/02/2024; New application|CEP granted|25/10/2021 |
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| 1444 | Macrogols, Type 3350 and 4000 | LIAONING OXIRANPHARM INC. Liaoyang CN | 100051050;100089345 | CEP 2024-418 - Rev 00 | 2025/03/26 | Valid | 26/03/2030 | Chemical | 2025/03/26 | New application|CEP granted|26/03/2025 | |
| 1407 | Ciclopirox | SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO., LTD. Luoyang Town CN | 100020594;100034407 | CEP 2019-102 - Rev 02 | 2025/03/25 | Valid | Chemical | 2025/03/25 | Renewal|CEP granted|25/03/2025; Minor revision|Accepted - CEP remains valid|06/09/2024; Notification|CEP granted|22/07/2020 |
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| 294 | Sulfadiazine | CHONGQING KANGLE PHARMACEUTICAL CO., LTD. Chongqing City CN | 100024105;100033269 | CEP 2019-042 - Rev 02 | 2025/03/25 | Valid | Chemical | 2025/03/25 | Renewal|CEP granted|25/03/2025; Minor revision|CEP granted|09/01/2023 |
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| 2858 | Mometasone furoate monohydrate, Micronised | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2018-303 - Rev 03 | 2025/03/25 | Valid | Chemical | 2025/03/25 | Renewal|CEP granted|25/03/2025; Notification|Accepted - CEP remains valid|23/06/2023; Notification|CEP granted|20/10/2022; Minor revision|CEP granted|15/09/2021 |
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| 311 | Aluminium oxide, hydrated, 0325 | SPI PHARMA, INC. Wilmington US | 100018352;100042876 | CEP 2008-270 - Rev 01 | 2025/03/25 | Valid | Chemical | 2025/03/25 | Monograph revision|CEP granted|25/03/2025 | ||
| 2414 | Octreotide | SINOPEP-ALLSINO BIOPHARMACEUTICAL CO., LTD. Lianyungang CN | 100034355;100054452 | CEP 2022-302 - Rev 01 | 2025/03/25 | Valid | 21/06/2029 | Chemical | 2025/03/25 | Minor revision|CEP granted|25/03/2025; New application|CEP granted|21/06/2024 |
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| 1012 | Famotidine | Union Quimico Farmaceutica, S.A. (Uquifa S.A.) Barcelona ES | 100000721;100001301 | CEP 2021-182 - Rev 01 | 2025/03/25 | Valid | 08/06/2028 | Chemical | 2025/03/25 | Minor revision|CEP granted|25/03/2025; New application|CEP granted|08/06/2023 |
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| 582 | Clindamycin hydrochloride, Process C | CHONGQING CARELIFE PHARMACEUTICAL CO., LTD. Chongqing CN | 100011995;100018631 | CEP 2024-484 - Rev 00 | 2025/03/25 | Valid | 25/03/2030 | Chemical | 2025/03/25 | New application|CEP granted|25/03/2025 |
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