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 |
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. | Collagen | TIGER AESTHETICS MEDICAL LLC Conshohocken US | 100054541;100096658 | CEP 2010-223 - Rev 01 | 2025/06/13 | Valid | TSE | 2025/06/13 | Notification|CEP granted|13/06/2025 | ||
942 | Omeprazole | CIPLA LIMITED Mumbai IN | 100006004;100018147 | CEP 1997-122 - Rev 06 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025 | ||
47 | Nicotinamide | LONZA GUANGZHOU PHARMACEUTICAL LTD Guangzhou CN | 100024633;100096813 | CEP 2004-110 - Rev 07 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Notification|CEP granted|13/06/2025; Administrative procedure|CEP granted|28/09/2023; Notification|Accepted - CEP remains valid|16/08/2023; Notification|CEP granted|05/05/2021 |
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1741 | Trimetazidine dihydrochloride | SHARON BIO-MEDICINE LIMITED Navi Mumbai IN | 100017869;100077413 | CEP 2010-075 - Rev 02 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025 | ||
14 | Calcium carbonate | SCORA Caffiers FR | 100017757;100026517 | CEP 1997-065 - Rev 05 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025 | ||
2049 | Econazole | PMC ISOCHEM Vert Le Petit FR | 100011861;100020972 | CEP 2020-047 - Rev 01 | 2025/06/13 | Valid | 18/09/2025 | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025; New application|CEP granted|18/09/2020 |
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1653 | Potassium clavulanate, diluted, with cellulose microcrystalline (0316) in ratio 1:1 | SINOPHARM WEIQIDA PHARMACEUTICAL CO., LTD Datong CN | 100033465;100082197 | CEP 2014-327 - Rev 01 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025; Renewal|CEP granted|05/03/2021 |
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1794 | Paclitaxel, Produced by a semi-synthetic process | Fujian South Pharmaceutical Co., Ltd. Sanming CN | 100012371;100021536 | CEP 2019-110 - Rev 03 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Renewal|CEP granted|13/06/2025; Notification|CEP granted|16/06/2022; Minor revision|Accepted - CEP remains valid|01/04/2022; Minor revision|CEP granted|08/04/2021 |
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2280 | Fexofenadine hydrochloride | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2012-278 - Rev 04 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Notification|CEP granted|13/06/2025; Minor revision|CEP granted|12/03/2024; Major revision|CEP granted|12/12/2022; Major revision|CEP granted|23/03/2021; Renewal|CEP granted|29/07/2020 |
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2591 | Celecoxib | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2016-037 - Rev 02 | 2025/06/13 | Valid | Chemical | 2025/06/13 | Notification|CEP granted|13/06/2025; Minor revision|Accepted - CEP remains valid|27/11/2023; Minor revision|CEP granted|22/02/2023; Renewal|CEP granted|17/08/2022; Minor revision|Accepted - CEP remains valid|29/04/2021; Minor revision|Accepted - CEP remains valid|17/08/2020 |
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1002 | Diclofenac sodium | SHANGHAI JINDI JIUZHOU PHARMACEUTICAL (ANYANG) CO., LTD. Anyang CN | 100033462;100052355 | CEP 2023-204 - Rev 00 | 2025/06/13 | Valid | 13/06/2030 | Chemical | 2025/06/13 | New application|CEP granted|13/06/2025 | |
2465 | Irbesartan, Form-A | CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN | 100048075;100079517 | CEP 2023-237 - Rev 01 | 2025/06/13 | Valid | 12/06/2029 | Chemical | 2025/06/13 | Minor revision|CEP granted|13/06/2025; New application|CEP granted|12/06/2024 |
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395 | Hydrogen peroxide solution (3 per cent) | ARKEMA FRANCE Puteaux FR | 100049819;100096345 | CEP 2022-162 - Rev 02 | 2025/06/13 | Valid | 20/12/2028 | Chemical | 2025/06/13 | Notification|CEP granted|13/06/2025; Administrative procedure|CEP granted|27/02/2024; New application|CEP granted|20/12/2023 |
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3035 | Tapentadol hydrochloride | ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100033956;100079880 | CEP 2024-524 - Rev 00 | 2025/06/13 | Valid | 13/06/2030 | Chemical | 2025/06/13 | New application|CEP granted|13/06/2025 | |
1108 | Indapamide, Micronised | KRKA TOVARNA ZDRAVIL D.D. NOVO MESTO Novo mesto SI | 100000627;100009540 | CEP 2024-179 - Rev 00 | 2025/06/13 | Valid | 13/06/2030 | Chemical | 2025/06/13 | New application|CEP granted|13/06/2025 | |
1292 | Amphotericin B, Intended For Use in the Manufacture of Parenteral Preparations | Asence Pharma Private Limited Vadodara IN | 100023319;100088414 | CEP 2024-118 - Rev 00 | 2025/06/13 | Valid | 13/06/2030 | Chemical | 2025/06/13 | New application|CEP granted|13/06/2025 | |
1995 | Sodium glycerophosphate, hydrated | MACCO ORGANIQUES, S.R.O. Bruntál CZ | 100017613;100026377 | CEP 2024-320 - Rev 00 | 2025/06/12 | Valid | 12/06/2030 | Chemical | 2025/06/12 | New application|CEP granted|12/06/2025 | |
721 | Ibuprofen, IPA route | SMS PHARMACEUTICALS LIMITED Hyderabad IN | 100011780;100061058 | CEP 2020-414 - Rev 02 | 2025/06/12 | Valid | 21/07/2027 | Chemical | 2025/06/12 | Minor revision|CEP granted|12/06/2025; Minor revision|CEP granted|25/03/2024; Minor revision|Accepted - CEP remains valid|05/04/2023; New application|CEP granted|21/07/2022 |
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2589 | Abacavir sulfate, Form-II | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2016-090 - Rev 01 | 2025/06/12 | Valid | Chemical | 2025/06/12 | Minor revision|CEP granted|12/06/2025; Renewal|CEP granted|27/01/2023; Minor revision|Accepted - CEP remains valid|13/07/2021; Minor revision|CEP granted|25/03/2021; Notification|Accepted - CEP remains valid|17/06/2020 |
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1386 | Albendazole | RAKSHIT DRUGS PRIVATE LIMITED Hyderabad IN | 100011756;100060531 | CEP 2023-268 - Rev 00 | 2025/06/12 | Valid | 12/06/2030 | Chemical | 2025/06/12 | New application|CEP granted|12/06/2025 |