| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 931 | Metformin Hydrochloride | SHANDONG SHOUGUANG BOKANG PHARMACEUTICAL CO., LTD. Yangkou Town CN | 100048458;100080267 | CEP 2019-141 - Rev 01 | 2025/12/12 | Valid | Chemical | 2025/12/12 | Renewal|CEP granted|12/12/2025; Minor revision|Rejected|16/08/2022 |
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| 2306 | Gemcitabine hydrochloride | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2009-208 - Rev 03 | 2025/12/12 | Valid | Chemical | 2025/12/12 | Minor revision|CEP granted|12/12/2025; Minor revision|Accepted - CEP remains valid|30/01/2024; Minor revision|Accepted - CEP remains valid|19/04/2022; Minor revision|Accepted - CEP remains valid|02/02/2022; Minor revision|CEP granted|02/11/2020 |
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| 1454 | Nonoxinol 9 | SYENSQO USA LLC Spartanburg US | 100038993;100061359 | CEP 2007-327 - Rev 02 | 2025/12/12 | Valid | Chemical | 2025/12/12 | Notification|CEP granted|12/12/2025; Minor revision|CEP granted|04/05/2022; Notification|Rejected|21/03/2022 |
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| 534 | Trimipramine maleate | LUNDBECK PHARMACEUTICALS ITALY S.P.A. Padova IT | 100005981;100005944 | CEP 2011-329 - Rev 01 | 2025/12/12 | Valid | Chemical | 2025/12/12 | Minor revision|CEP granted|12/12/2025; Minor revision|Accepted - CEP remains valid|26/08/2024 |
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| 1559 | Risperidone | CHIERON ACTIVE INGREDIENTS PRIVATE LIMITED Hyderabad IN | 100053345;100094249 | CEP 2018-210 - Rev 02 | 2025/12/12 | Valid | Chemical | 2025/12/12 | Renewal|CEP granted|12/12/2025; Notification|CEP granted|17/06/2025 |
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| 2362 | Rifaximin | LUOHE CHIEF PHARMACEUTICAL CO., LTD. Luohe City CN | 100043312;100071644 | CEP 2021-420 - Rev 01 | 2025/12/12 | Valid | 06/06/2028 | Chemical | 2025/12/12 | Major revision|CEP granted|12/12/2025; New application|CEP granted|06/06/2023 |
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| 2932 | Rivaroxaban, Process-2, Symed Labs Limited Unit-I, 1RVS | SYMED LABS LIMITED Hyderabad IN | 100018727;100090820 | CEP 2025-385 - Rev 00 | 2025/12/12 | Valid | 12/12/2030 | Chemical | 2025/12/12 | New application|CEP granted|12/12/2025 | |
| 566 | Penicillamine | FLEMING LABORATORIES LIMITED Hyderabad IN | 100015641;100067279 | CEP 2022-136 - Rev 01 | 2025/12/12 | Valid | 17/06/2029 | Chemical | 2025/12/12 | Minor revision|CEP granted|12/12/2025; New application|CEP granted|17/06/2024 |
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| . | Purified bovine Haemoglobin | SOUTH PACIFIC SERA LIMITED Timaru NZ | 100044527;100099043 | CEP 2025-262 - Rev 00 | 2025/12/12 | Valid | 12/12/2030 | TSE | 2025/12/12 | New application|CEP granted|12/12/2025 | |
| 1758 | Moxonidine | MICRO LABS LIMITED Bengaluru IN | 100017819;100077269 | CEP 2025-322 - Rev 00 | 2025/12/12 | Valid | 12/12/2030 | Chemical | 2025/12/12 | New application|CEP granted|12/12/2025 | |
| 2768 | Fluticasone furoate, Micronised | AARTI PHARMALABS LIMITED Mulund (W), Mumbai IN | 100045727;100075371 | CEP 2024-361 - Rev 00 | 2025/12/12 | Valid | 12/12/2030 | Chemical | 2025/12/12 | New application|CEP granted|12/12/2025 | |
| 2760 | Brimonidine tartrate | SYMED LABS LIMITED Hyderabad IN | 100018727;100090820 | CEP 2018-124 - Rev 01 | 2025/12/11 | Valid | Chemical | 2025/12/11 | Renewal|CEP granted|11/12/2025 | ||
| 2307 | Modafinil | ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN | 100006039;100002980 | CEP 2014-073 - Rev 01 | 2025/12/11 | Valid | Chemical | 2025/12/11 | Minor revision|CEP granted|11/12/2025; Minor revision|Accepted - CEP remains valid|06/07/2022; Renewal|CEP granted|14/01/2021 |
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| 2064 | Chondroitin sulfate sodium, Process A and B | BIOIBERICA, S.A.U. Palafolls ES | 100000136;100043853 | CEP 2001-063 - Rev 07 | 2025/12/11 | Valid | TSE | 2025/12/11 | Minor revision|CEP granted|11/12/2025; Minor revision|CEP granted|26/10/2022; Major revision|CEP granted|24/03/2022 |
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| 1012 | Famotidine | GEDEON RICHTER PLC. Budapest HU | 100000640;100001653 | CEP 1999-054 - Rev 04 | 2025/12/11 | Valid | Chemical | 2025/12/11 | Minor revision|CEP granted|11/12/2025; Minor revision|CEP granted|18/02/2022 |
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| 601 | Dimenhydrinate | SHANGHAI WONDER PHARMACEUTICAL CO., LTD Shanghai CN | 100020697;100029440 | CEP 2020-110 - Rev 02 | 2025/12/11 | Valid | 03/03/2027 | Chemical | 2025/12/11 | Minor revision|CEP granted|11/12/2025; Notification|Accepted - CEP remains valid|07/07/2025; Minor revision|CEP granted|15/02/2024; New application|CEP granted|03/03/2022 |
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| 1648 | Thioctic acid | CADCHEM LABORATORIES LIMITED Chandigarh IN | 100039011;100083960 | CEP 2024-419 - Rev 00 | 2025/12/11 | Valid | 11/12/2030 | Chemical | 2025/12/11 | New application|CEP granted|11/12/2025 | |
| 1648 | Thioctic acid | KINSY S.L. Murcia ES | 100025606;100057039 | CEP 2024-321 - Rev 00 | 2025/12/11 | Valid | 11/12/2030 | Chemical | 2025/12/11 | New application|CEP granted|11/12/2025 | |
| 2445 | Adapalene | MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN | 100020971;100029680 | CEP 2023-462 - Rev 00 | 2025/12/11 | Valid | 11/12/2030 | Chemical | 2025/12/11 | New application|CEP granted|11/12/2025 | |
| 1699 | Mesalazine, Pubagang site | ZHEJIANG HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN | 100034135;100082085 | CEP 2021-400 - Rev 01 | 2025/12/10 | Valid | 17/12/2026 | Chemical | 2025/12/10 | Minor revision|CEP granted|10/12/2025; Minor revision|Accepted - CEP remains valid|04/10/2024; New application|CEP granted|17/12/2021 |
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