| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 944 | Piroxicam | PFIZER INC. New York US | 100004191;100077681 | CEP 2001-427 - Rev 02 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025 | ||
| 3059 | Melatonin | SWATI SPENTOSE PRIVATE LIMITED Mumbai IN | 100021605;100052219 | CEP 2023-075 - Rev 03 | 2025/04/25 | Valid | 22/05/2029 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|CEP granted|17/02/2025; Notification|CEP granted|16/09/2024; New application|CEP granted|22/05/2024 |
|
| 2781 | Tolterodine tartrate | HETERO DRUGS LIMITED Hyderabad IN | 100008415;100014434 | CEP 2020-032 - Rev 01 | 2025/04/25 | Valid | 17/03/2026 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|Accepted - CEP remains valid|24/08/2023; New application|CEP granted|17/03/2021 |
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| 2254 | Moxifloxacin hydrochloride | ENALTEC LABS PRIVATE LIMITED Navi Mumbai IN | 100015510;100024234 | CEP 2022-487 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2296 | Pantoprazole sodium sesquihydrate | SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN | 100017920;100052986 | CEP 2013-350 - Rev 01 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Major revision|CEP granted|25/04/2025; Renewal|CEP granted|15/09/2020 |
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| 2173 | Gabapentin | ZHEJIANG BAMBOO PHARMACEUTICALS CO.,LTD. Shaoxing CN | 100047946;100079294 | CEP 2023-027 - Rev 02 | 2025/04/25 | Valid | 04/01/2029 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|CEP granted|11/03/2024; New application|CEP granted|04/01/2024 |
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| 1513 | Etofenamate | DUKE CHEM, S.A.U. Olérdola ES | 100022432;100031112 | CEP 2014-154 - Rev 02 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|CEP granted|27/02/2024; Renewal|CEP granted|02/10/2020 |
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| 916 | Hydroxyzine hydrochloride | IPCA LABORATORIES LIMITED Mumbai IN | 100011685;100018680 | CEP 2010-076 - Rev 04 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Minor revision|CEP granted|11/09/2024; Notification|Accepted - CEP remains valid|23/06/2023; Minor revision|CEP granted|03/08/2021 |
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| 2888 | Rupatadine fumarate, Micronised and Non-micronised | CADILA PHARMACEUTICALS LIMITED Ankleshwar IN | 100003616;100000498 | CEP 2018-161 - Rev 03 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Renewal|CEP granted|25/04/2025; Minor revision|CEP granted|25/01/2024; Minor revision|Accepted - CEP remains valid|01/08/2022; Minor revision|CEP granted|18/12/2020 |
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| 2333 | Fluvastatin sodium, Amorphous | BIOCON LIMITED Bengaluru IN | 100011487;100018595 | CEP 2016-075 - Rev 01 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Renewal|CEP granted|14/10/2022; Minor revision|Rejected|25/01/2022; Major revision|Rejected|14/09/2021 |
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| 1750 | Fluticasone propionate, Micronised | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED London GB | 100005535;100093170 | CEP 2018-229 - Rev 03 | 2025/04/25 | Valid | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025; Renewal|CEP granted|16/12/2024; Monograph revision|Accepted - CEP remains valid|12/07/2021; Notification|CEP granted|07/12/2020 |
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| 855 | Praziquantel | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100053537 | CEP 2021-162 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 823 | Etoposide | MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN | 100023737;100061579 | CEP 2020-074 - Rev 02 | 2025/04/25 | Valid | 25/07/2027 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; Administrative procedure|CEP granted|30/04/2024; New application|CEP granted|25/07/2022 |
|
| 391 | Furosemide | MANGALAM DRUGS & ORGANICS LTD. Mumbai IN | 100012477;100021137 | CEP 2019-063 - Rev 02 | 2025/04/25 | Valid | 07/09/2026 | Chemical | 2025/04/25 | Notification|CEP granted|25/04/2025; Major revision|CEP granted|02/03/2023 |
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| 2541 | Quetiapine Fumarate | ZHEJIANG SYNCOZYMES BIO-PHARMACEUTICAL CO. LTD. Shaoxing CN | 100049378;100084024 | CEP 2024-190 - Rev 01 | 2025/04/25 | Valid | 08/04/2030 | Chemical | 2025/04/25 | Administrative procedure|CEP granted|25/04/2025; New application|CEP granted|08/04/2025 |
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| 2358 | Teicoplanin, Changhai site | ZHEJIANG MEDICINE CO., LTD. Shaoxing CN | 100022357;100084942 | CEP 2022-436 - Rev 01 | 2025/04/25 | Valid | 10/02/2028 | Chemical | 2025/04/25 | Minor revision|CEP granted|25/04/2025; New application|CEP granted|10/02/2023 |
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| 2932 | Rivaroxaban | HIKAL LIMITED Bangalore IN | 100014769;100023445 | CEP 2023-351 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 141 | Ethionamide | APICHEM LABORATORIES PRIVATE LIMITED Yadadri Bhuvanagiri District IN | 100049373;100087707 | CEP 2024-502 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2577 | Oxcarbazepine | ARENE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100033956;100079880 | CEP 2024-343 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 | |
| 2288 | Citalopram hydrobromide, Sulfuric Acid Process, Micronised and non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2025-004 - Rev 00 | 2025/04/25 | Valid | 25/04/2030 | Chemical | 2025/04/25 | New application|CEP granted|25/04/2025 |
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