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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2287 | Fluconazole | GRANULES INDIA LIMITED Hyderabad IN | 100011671;100018694 | CEP 2009-075 - Rev 02 | 2024/06/12 | Withdrawn by Holder | 2024/08/14 | Chemical | 2024/06/12 | ||
2089 | Acarbose | HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. Hangzhou CN | 100016034;100062035 | CEP 2009-224 - Rev 05 | 2024/06/12 | Valid | Chemical | 2024/06/12 | Minor revision|CEP granted|12/06/2024; Minor revision|CEP granted|10/03/2021; Minor revision|CEP granted|10/12/2020 |
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1472 | Sodium hyaluronate, Intrinsic viscosity 1.8 m3/kg, by fermentation, for parenteral administration including intra-articular administration and for intra-ocular use | BLOOMAGE BIOTECHNOLOGY CORP., LTD. Jinan CN | 100024983;100034173 | CEP 2021-220 - Rev 02 | 2024/06/12 | Valid | 19/04/2028 | Chemical | 2024/06/12 | Minor revision|CEP granted|12/06/2024; Minor revision|CEP granted|16/06/2023; New application|CEP granted|19/04/2023 |
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74 | Codeine phosphate hemihydrate, Process 2 | ALCALIBER S.A.U. Madrid ES | 100020633;100087731 | CEP 2021-054 - Rev 03 | 2024/06/12 | Valid | 29/03/2027 | Chemical | 2024/06/12 | Minor revision|CEP granted|12/06/2024; Notification|CEP granted|23/01/2024; Minor revision|CEP granted|24/07/2023; New application|CEP granted|29/03/2022 |
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1425 | Fosfomycin trometamol | ZACH SYSTEM Avrillé FR | 100012282;100021396 | CEP 2020-370 - Rev 03 | 2024/06/12 | Valid | 02/09/2026 | Chemical | 2025/04/02 | Notification|Accepted - CEP remains valid|02/04/2025; Minor revision|CEP granted|12/06/2024; Minor revision|CEP granted|03/07/2023; Notification|Accepted - CEP remains valid|25/11/2022; Minor revision|CEP granted|09/12/2021; New application|CEP granted|02/09/2021 |
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3087 | Ticagrelor | SHENZHEN SALUBRIS PHARMACEUTICALS CO., LTD. Shenzhen City CN | 100033629;100087648 | CEP 2022-491 - Rev 00 | 2024/06/12 | Valid | 12/06/2029 | Chemical | 2024/06/12 | New application|CEP granted|12/06/2024 | |
2230 | Latanoprost | MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN | 100011732;100023530 | CEP 2023-113 - Rev 00 | 2024/06/12 | Valid | 12/06/2029 | Chemical | 2024/06/12 | New application|CEP granted|12/06/2024 | |
1567 | Sodium stearyl fumarate | RANK ORGANICS CHEMICAL PVT. LTD. Boisar IN | 100049838;100086973 | CEP 2023-052 - Rev 00 | 2024/06/12 | Valid | 12/06/2029 | Chemical | 2024/06/12 | New application|CEP granted|12/06/2024 | |
2465 | Irbesartan, Form-A | CPL PHARMACEUTICALS PRIVATE LIMITED Ahmedabad IN | 100048075;100079517 | CEP 2023-237 - Rev 00 | 2024/06/12 | Valid | 12/06/2029 | Chemical | 2024/06/12 | New application|CEP granted|12/06/2024 | |
234 | Norethisterone, 202311 | BAYER AG Leverkusen DE | 100000011;100001505 | CEP 2023-427 - Rev 00 | 2024/06/12 | Valid | 12/06/2029 | Chemical | 2024/06/12 | New application|CEP granted|12/06/2024 | |
1681 | Tramadol hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2002-232 - Rev 07 | 2024/06/12 | Valid | Chemical | 2024/06/12 | Minor revision|CEP granted|12/06/2024; Minor revision|Accepted - CEP remains valid|20/10/2022 |
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260 | Amoxicillin trihydrate | INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO., LTD. Tuoketuo CN | 100019603;100028364 | CEP 2007-315 - Rev 03 | 2024/06/12 | Valid | Chemical | 2024/06/12 | Minor revision|CEP granted|12/06/2024 | ||
2306 | Gemcitabine hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | 100008538;100018201 | CEP 2007-021 - Rev 02 | 2024/06/12 | Valid | Chemical | 2024/06/12 | Minor revision|CEP granted|12/06/2024 | ||
1359 | Pivmecillinam hydrochloride | FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT | 100015105;100057989 | CEP 2004-262 - Rev 07 | 2024/06/12 | Valid | Chemical | 2024/06/12 | Minor revision|CEP granted|12/06/2024; Major revision|CEP granted|01/02/2023; Minor revision|CEP granted|17/01/2022; Notification|CEP granted|02/02/2021; Notification|Accepted - CEP remains valid|05/02/2020 |
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708 | Cefalexin monohydrate, Powder, compacted | CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. Delft NL | 100002351;100005259 | CEP 1997-007 - Rev 08 | 2024/06/12 | Valid | Chemical | 2024/06/12 | Notification|CEP granted|12/06/2024; Minor revision|Accepted - CEP remains valid|25/01/2024; Minor revision|Accepted - CEP remains valid|13/11/2023; Notification|Accepted - CEP remains valid|09/12/2021 |
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687 | Salbutamol sulfate | FDC Limited Mumbai IN | 100011646;100021030 | CEP 2015-212 - Rev 02 | 2024/06/12 | Valid | Chemical | 2025/02/06 | Minor revision|Accepted - CEP remains valid|06/02/2025; Minor revision|CEP granted|12/06/2024; Monograph revision|CEP granted|01/02/2024; Renewal|CEP granted|04/07/2022 |
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1322 | Fenofibrate | JIANGSU NHWA PHARMACEUTICAL CO., LTD. Xuzhou City CN | 100016628;100080030 | CEP 2007-350 - Rev 02 | 2024/06/12 | Valid | Chemical | 2024/06/12 | Major revision|CEP granted|12/06/2024 | ||
2132 | Torasemide | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN | 100011833;100018698 | CEP 2009-061 - Rev 05 | 2024/06/12 | Valid | Chemical | 2024/06/12 | Minor revision|CEP granted|12/06/2024; Minor revision|Accepted - CEP remains valid|21/11/2023; Minor revision|Accepted - CEP remains valid|01/12/2022; Administrative procedure|CEP granted|21/04/2022; Major revision|CEP granted|13/04/2022; Notification|Accepted - CEP remains valid|03/06/2021; Minor revision|Accepted - CEP remains valid|23/09/2020 |
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2988 | Fingolimod hydrochloride | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2019-301 - Rev 02 | 2024/06/12 | Valid | 10/02/2026 | Chemical | 2024/06/12 | Monograph revision|CEP granted|12/06/2024; Minor revision|CEP granted|18/11/2022; Minor revision|Accepted - CEP remains valid|10/12/2021 |
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77 | Dapsone | EXTROVIS AG Baar CH | 100040194;100065405 | CEP 2022-379 - Rev 00 | 2024/06/12 | Valid | 12/06/2029 | Chemical | 2024/06/12 | New application|CEP granted|12/06/2024 |