| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2992 | Lacosamide | JUBILANT BIOSYS LIMITED Mysuru IN | 100055198;100098088 | CEP 2019-049 - Rev 02 | 2026/01/13 | Valid | 21/12/2025 | Chemical | 2026/01/13 | Notification|CEP granted|13/01/2026; Notification|CEP granted|12/08/2022 |
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| 1458 | Oxfendazole For Veterinary Use, Process II | ALIVIRA ANIMAL HEALTH LIMITED Visakhapatnam IN | 100033528;100052489 | CEP 2021-071 - Rev 03 | 2026/01/13 | Valid | Chemical | 2026/01/13 | Renewal|CEP granted|13/01/2026; Notification|CEP granted|18/04/2023; Minor revision|CEP granted|20/10/2021; New application|CEP granted|31/03/2021 |
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| 1491 | Amlodipine besilate | AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN | 100046306;100076393 | CEP 2019-310 - Rev 02 | 2026/01/13 | Valid | 16/08/2026 | Chemical | 2026/01/13 | Monograph revision|CEP granted|13/01/2026; Minor revision|CEP granted|15/11/2024 |
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| 2898 | Atazanavir sulfate, Micronised and non-micronised, form A | GRANULES INDIA LIMITED Hyderabad IN | 100011671;100097387 | CEP 2020-279 - Rev 02 | 2026/01/13 | Valid | 20/06/2027 | Chemical | 2026/01/13 | Minor revision|CEP granted|13/01/2026; Notification|CEP granted|10/06/2024; New application|CEP granted|20/06/2022 |
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| 1573 | Sumatriptan succinate, Process II | DR. REDDY'S LABORATORIES LIMITED Hyderabad IN | 100003991;100000217 | CEP 2023-022 - Rev 01 | 2026/01/12 | Valid | 30/10/2028 | Chemical | 2026/01/12 | Minor revision|CEP granted|12/01/2026; New application|CEP granted|30/10/2023 |
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| 821 | Estradiol hemihydrate | SCHMITT PHARMA GMBH Kleinmachnow DE | 100048120;100079611 | CEP 2025-211 - Rev 00 | 2026/01/12 | Valid | 12/01/2031 | Chemical | 2026/01/12 | New application|CEP granted|12/01/2026 | |
| 248 | Suxamethonium Chloride | SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN | 100032307;100099917 | CEP 2013-210 - Rev 02 | 2026/01/12 | Valid | Chemical | 2026/01/12 | Notification|CEP granted|12/01/2026; Minor revision|CEP granted|30/05/2024; Renewal|CEP granted|15/02/2021 |
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| 1756 | Lamotrigine, Anhydrous Form | ZYDUS LIFESCIENCES LIMITED Vadodara IN | 100005979;100074301 | CEP 2018-295 - Rev 04 | 2026/01/12 | Valid | Chemical | 2026/01/12 | Renewal|CEP granted|12/01/2026; Minor revision|CEP granted|30/01/2024; Minor revision|Accepted - CEP remains valid|24/04/2023; Minor revision|CEP granted|02/12/2022; Notification|CEP granted|08/07/2022 |
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| 2411 | Epinastine hydrochloride | WUHAN CALMLAND PHARMACEUTICALS CO., LTD. Wuhan CN | 100049301;100083738 | CEP 2024-295 - Rev 00 | 2026/01/12 | Valid | 12/01/2031 | Chemical | 2026/01/12 | New application|CEP granted|12/01/2026 | |
| 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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