| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Foetal Calf Serum, Defined, characterised, standard | HYCLONE LABORATORIES LLC. Logan US | 100012797;100022115 | CEP 2000-076 - Rev 06 | 2025/05/07 | Valid | TSE | 2025/05/07 | Notification|CEP granted|07/05/2025; Major revision|CEP granted|06/07/2022; Notification|Rejected|25/03/2022; Notification|Accepted - CEP remains valid|23/03/2021; Notification|Accepted - CEP remains valid|27/08/2020; Notification|CEP granted|24/06/2020 |
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| 1705 | Sertraline hydrochloride, Alternate process | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2012-218 - Rev 05 | 2025/05/07 | Valid | Chemical | 2026/03/03 | Notification|Accepted - CEP remains valid|03/03/2026; Minor revision|CEP granted|07/05/2025; Minor revision|Accepted - CEP remains valid|04/10/2023; Minor revision|Accepted - CEP remains valid|17/02/2023; Minor revision|CEP granted|07/09/2022 |
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| 816 | Cinnarizine | FLEMING LABORATORIES LIMITED Nawabpet Village IN | 100015641;100024384 | CEP 2015-019 - Rev 01 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Monograph revision|CEP granted|07/05/2025; Renewal|CEP granted|10/05/2022; Minor revision|Accepted - CEP remains valid|03/02/2021 |
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| 888 | Ciprofloxacin Hydrochloride, Process 105 | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. Shaoxing CN | 100022562;100093113 | CEP 2019-007 - Rev 05 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Renewal|CEP granted|07/05/2025; Minor revision|CEP granted|29/10/2024; Minor revision|CEP granted|26/06/2023; Minor revision|CEP granted|16/08/2024; Notification|Rejected|23/01/2023; Minor revision|CEP granted|01/08/2022 |
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| 2849 | Hydroxychloroquine sulfate | MANGALAM DRUGS & ORGANICS LTD. Mumbai IN | 100012477;100021137 | CEP 2019-151 - Rev 02 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Renewal|CEP granted|07/05/2025; Notification|CEP granted|19/07/2024 |
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| 2600 | Olmesartan medoxomil, Process II | APITORIA PHARMA PRIVATE LIMITED Hyderabad IN | 100049668;100086364 | CEP 2020-112 - Rev 04 | 2025/05/07 | Valid | Chemical | 2025/05/07 | Renewal|CEP granted|07/05/2025; Notification|CEP granted|11/01/2024; Minor revision|CEP granted|05/06/2023; Minor revision|CEP granted|19/08/2022; New application|CEP granted|31/07/2020 |
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| 1335 | Itraconazole | NOSCH LABS PRIVATE LIMITED Hyderabad IN | 100020550;100029297 | CEP 2011-283 - Rev 01 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Minor revision|CEP granted|05/05/2025; Minor revision|Rejected|21/02/2025 |
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| 2126 | Cefepime dihydrochloride monohydrate, Sterile | QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD. Jinan CN | 100033695;100052910 | CEP 2011-286 - Rev 02 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Major revision|CEP granted|05/05/2025; Major revision|CEP granted|21/12/2021 |
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| 2306 | Gemcitabine hydrochloride | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2008-161 - Rev 03 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Notification|CEP granted|05/05/2025; Notification|CEP granted|20/12/2021; Notification|Accepted - CEP remains valid|22/02/2021 |
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| 394 | Hydrochlorothiazide | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2001-304 - Rev 13 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Minor revision|CEP granted|05/05/2025; Notification|Accepted - CEP remains valid|20/02/2023; Minor revision|CEP granted|03/10/2022; Minor revision|CEP granted|01/12/2021; Minor revision|CEP granted|09/12/2020 |
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| 1058 | Vancomycin hydrochloride | CHONGQING DAXIN PHARMACEUTICAL CO., LTD. Shuitu Town CN | 100011996;100039007 | CEP 2018-197 - Rev 01 | 2025/05/05 | Valid | Chemical and TSE | 2025/05/05 | Renewal|CEP granted|05/05/2025 | ||
| 1551 | Nomegestrol acetate, Nomac grade B | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2014-178 - Rev 06 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Minor revision|CEP granted|05/05/2025; Minor revision|CEP granted|25/09/2024; Notification|CEP granted|20/12/2021; Minor revision|CEP granted|22/10/2021; Minor revision|CEP granted|10/07/2020; Monograph revision|CEP granted|06/05/2020 |
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| 464 | Amitriptyline hydrochloride, Process II | DIPHARMA FRANCIS S.R.L. Baranzate IT | 100014675;100030401 | CEP 2019-193 - Rev 01 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Renewal|CEP granted|05/05/2025 | ||
| 658 | Chlorhexidine digluconate solution, CDG | MEDICHEM, S.A. Sant Joan Despí ES | 100001017;100002951 | CEP 2017-128 - Rev 01 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Minor revision|CEP granted|05/05/2025; Monograph revision|Accepted - CEP remains valid|26/03/2025; Minor revision|Accepted - CEP remains valid|13/07/2023; Renewal|CEP granted|18/07/2022; Notification|Accepted - CEP remains valid|10/06/2021; Notification|Accepted - CEP remains valid|07/08/2020 |
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| 396 | Hydrogen peroxide solution (30 per cent) | SOLVAY CHEMIE B.V. HERTEN NL | 100024348;100033521 | CEP 2018-167 - Rev 01 | 2025/05/05 | Valid | Chemical | 2025/05/05 | Renewal|CEP granted|05/05/2025; Minor revision|Accepted - CEP remains valid|09/04/2024 |
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| 2631 | Rosuvastatin calcium | ZHEJIANG LEPU PHARMACEUTICAL CO., LTD Taizhou City CN | 100033518;100052465 | CEP 2020-243 - Rev 01 | 2025/05/05 | Valid | 31/03/2027 | Chemical | 2025/05/05 | Minor revision|CEP granted|05/05/2025; New application|CEP granted|31/03/2022 |
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| 2779 | Solifenacin succinate | DIJIA PHARMACEUTICAL GROUP CO., LTD. Weihai CN | 100048717;100080764 | CEP 2024-479 - Rev 00 | 2025/05/05 | Valid | 05/05/2030 | Chemical | 2025/05/05 | New application|CEP granted|05/05/2025 | |
| 931 | Metformin Hydrochloride | TRIMAX BIO SCIENCES PRIVATE LIMITED Raichur IN | 100048452;100080257 | CEP 2024-132 - Rev 00 | 2025/05/05 | Valid | 05/05/2030 | Chemical | 2025/05/05 | New application|CEP granted|05/05/2025 | |
| 67 | Folic acid hydrate | JIANGXI TIANXIN PHARMACEUTICAL CO., LTD. Leping CN | 100016959;100025761 | CEP 2022-378 - Rev 00 | 2025/05/05 | Valid | 05/05/2030 | Chemical | 2025/08/11 | Minor revision|Accepted - CEP remains valid|11/08/2025; New application|CEP granted|05/05/2025 |
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| 2775 | Nebivolol hydrochloride | TORRENT PHARMACEUTICALS LIMITED Ahmedabad IN | 100004452;100001862 | CEP 2023-122 - Rev 01 | 2025/05/05 | Valid | 19/07/2029 | Chemical | 2025/05/05 | Minor revision|CEP granted|05/05/2025; New application|CEP granted|19/07/2024 |
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