| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2063 | Omega-3-acid ethyl esters 60, Containing mixed tocopherols | K.D. PHARMA BEXBACH GMBH Bexbach DE | 100016421;100092038 | CEP 2009-326 - Rev 02 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Minor revision|CEP granted|08/01/2026 | ||
| 67 | Folic acid hydrate | DSM-FIRMENICH SWITZERLAND AG Kaiseraugst CH | 100053293;100094111 | CEP 1996-045 - Rev 08 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Minor revision|CEP granted|08/01/2026; Notification|CEP granted|17/07/2025; Administrative procedure|CEP granted|10/08/2023; Minor revision|CEP granted|06/07/2023; Monograph revision|Accepted - CEP remains valid|11/05/2022; Minor revision|CEP granted|27/04/2021 |
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| 2063 | Omega-3-acid ethyl esters 60, Containing alpha tocopherol | K.D. PHARMA BEXBACH GMBH Bexbach DE | 100016421;100092038 | CEP 2007-042 - Rev 01 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Minor revision|CEP granted|08/01/2026 | ||
| 941 | Nortriptyline hydrochloride | OLON S.P.A. Rodano IT | 100012085;100019537 | CEP 2013-070 - Rev 03 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Minor revision|CEP granted|08/01/2026; Administrative procedure|CEP granted|31/05/2023; Minor revision|CEP granted|19/05/2023; Minor revision|Accepted - CEP remains valid|16/05/2022 |
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| 1045 | Sulpiride | ICROM S.R.L. Concorezzo IT | 100022464;100031145 | CEP 2011-074 - Rev 04 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Minor revision|CEP granted|08/01/2026; Minor revision|CEP granted|13/03/2023; Notification|CEP granted|27/11/2020; Minor revision|CEP granted|25/02/2020 |
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| 678 | Sodium valproate | ANJAN DRUG PRIVATE LIMITED Alathur IN | 100023458;100032594 | CEP 2003-180 - Rev 04 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Minor revision|CEP granted|08/01/2026 | ||
| 2825 | Tigecycline, Form II | TAPI NL B.V. Amsterdam NL | 100003852;100094134 | CEP 2018-130 - Rev 03 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Renewal|CEP granted|08/01/2026; Notification|CEP granted|10/03/2022; Notification|CEP granted|21/12/2021; Monograph revision|Accepted - CEP remains valid|17/11/2021 |
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| 942 | Omeprazole | ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD. Jinhua City CN | 100024897;100034088 | CEP 2016-109 - Rev 02 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Notification|CEP granted|08/01/2026; Administrative procedure|CEP granted|30/09/2022; Renewal|CEP granted|16/09/2022; Minor revision|CEP granted|17/03/2022; Minor revision|CEP granted|29/04/2020 |
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| 1422 | Etodolac, Micronised, non-micronised | ZAKŁADY FARMACEUTYCZNE POLPHARMA S.A. Starogard Gdański PL | 100000470;100001572 | CEP 2013-134 - Rev 04 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Notification|CEP granted|08/01/2026; Minor revision|CEP granted|02/12/2024; Minor revision|CEP granted|07/02/2023 |
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| 576 | Allopurinol | ANUH PHARMA LTD. Mumbai IN | 100021566;100030259 | CEP 2023-078 - Rev 01 | 2026/01/08 | Valid | 25/09/2029 | Chemical | 2026/01/08 | Minor revision|CEP granted|08/01/2026; New application|CEP granted|25/09/2024 |
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| 2617 | Aripiprazole, Form B | NEULAND LABORATORIES LIMITED Hyderabad IN | 100011545;100062134 | CEP 2017-289 - Rev 04 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Minor revision|CEP granted|08/01/2026; Renewal|Accepted - CEP remains valid|21/01/2025; Minor revision|CEP granted|25/04/2024; Notification|CEP granted|24/03/2023; Notification|CEP granted|08/09/2021; Monograph revision|Accepted - CEP remains valid|19/07/2021 |
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| 2733 | Escitalopram oxalate, Micronised, milled and non-micronised | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Taizhou CN | 100011833;100018698 | CEP 2016-178 - Rev 02 | 2026/01/08 | Valid | Chemical | 2026/01/08 | Minor revision|CEP granted|08/01/2026; Minor revision|CEP granted|23/02/2024; Renewal|CEP granted|19/01/2023; Minor revision|CEP granted|23/07/2021; Notification|Accepted - CEP remains valid|04/09/2020 |
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| 1075 | Budesonide | CORAL DRUGS PRIVATE LIMITED New Delhi IN | 100019182;100042823 | CEP 2016-020 - Rev 01 | 2026/01/06 | Valid | Chemical | 2026/01/06 | Minor revision|CEP granted|06/01/2026; Renewal|CEP granted|15/11/2022 |
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| 727 | Lidocaine | APEX HEALTHCARE LIMITED Ankleshwar IN | 100039365;100061975 | CEP 2024-291 - Rev 00 | 2026/01/06 | Valid | 06/01/2031 | Chemical | 2026/01/06 | New application|CEP granted|06/01/2026 | |
| 760 | Cytarabine | MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Mumbai IN | 100023737;100061579 | CEP 2012-251 - Rev 03 | 2026/01/06 | Valid | Chemical | 2026/01/06 | Notification|CEP granted|06/01/2026; Administrative procedure|CEP granted|30/04/2024; Minor revision|CEP granted|19/05/2022; Minor revision|Accepted - CEP remains valid|19/07/2021; Minor revision|Rejected|19/03/2021 |
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| 2910 | Trifluridine, Crystalline form | HETERO LABS LIMITED Hyderabad IN | 100011681;100018664 | CEP 2023-437 - Rev 00 | 2026/01/06 | Valid | 06/01/2031 | Chemical | 2026/01/06 | New application|CEP granted|06/01/2026 | |
| 97 | Morphine hydrochloride trihydrate | S.A.L.A.R.S. S.p.A. Como IT | 100017528;100026302 | CEP 2009-339 - Rev 02 | 2026/01/06 | Valid | Chemical | 2026/01/06 | Minor revision|CEP granted|06/01/2026; Monograph revision|CEP granted|20/06/2024 |
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| 1362 | Prilocaine | MOEHS IBERICA S.L. Rubi ES | 100029092;100068825 | CEP 2024-589 - Rev 00 | 2026/01/06 | Valid | 06/01/2031 | Chemical | 2026/01/06 | New application|CEP granted|06/01/2026 | |
| 1092 | Cyclizine Hydrochloride | BAJAJ HEALTHCARE LIMITED Thane IN | 100021782;100061986 | CEP 2024-447 - Rev 00 | 2026/01/06 | Valid | 06/01/2031 | Chemical | 2026/01/06 | New application|CEP granted|06/01/2026 | |
| 1197 | Dicycloverine Hydrochloride | AMI LIFESCIENCES PRIVATE LIMITED Vadodara IN | 100021822;100030527 | CEP 2024-517 - Rev 00 | 2026/01/06 | Valid | 06/01/2031 | Chemical | 2026/01/06 | New application|CEP granted|06/01/2026 |
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